Rule2023-25428
Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format
Primary source
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Published
November 21, 2023
Effective
May 20, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations concerning direct-to- consumer (DTC) advertisements (ads) for human prescription drugs presented in television or radio format and stating the name of the drug and its conditions of use (DTC TV/radio ads). Specifically, the final rule implements a requirement of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by the Food and Drug Administration Amendments Act of 2007 (FDAAA), that in such DTC TV/radio ads, the major statement relating to side effects and contraindications must be presented in a clear, conspicuous, and neutral manner. As directed by FDAAA, FDA is establishing standards to determine whether the major statement in DTC TV/radio ads is presented in a clear, conspicuous, and neutral manner.
Full Text
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[Federal Register Volume 88, Number 223 (Tuesday, November 21, 2023)]
[Rules and Regulations]
[Pages 80958-80984]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-25428]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 202
[Docket No. FDA-2009-N-0582]
RIN 0910-AG27
Direct-to-Consumer Prescription Drug Advertisements: Presentation
of the Major Statement in a Clear, Conspicuous, and Neutral Manner in
Advertisements in Television and Radio Format
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing a final rule to amend its regulations concerning direct-to-
consumer (DTC) advertisements (ads) for human prescription drugs
presented in television or radio format and stating the name of the
drug and its conditions of use (DTC TV/radio ads). Specifically, the
final rule implements a requirement of the Federal Food, Drug, and
Cosmetic Act (FD&C Act), added by the Food and Drug Administration
Amendments Act of 2007 (FDAAA), that in such DTC TV/radio ads, the
major statement relating to side effects and contraindications must be
presented in a clear, conspicuous, and neutral manner. As directed by
FDAAA, FDA is establishing standards to determine whether the major
statement in DTC TV/radio ads is presented in a clear, conspicuous, and
neutral manner.
DATES: This rule is effective May 20, 2024. The compliance date of this
rule is November 20, 2024.
ADDRESSES: For access to the docket to read background documents or
comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.
FOR FURTHER INFORMATION CONTACT:
With regard to human drug products: Suzanna Boyle, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1200, <a href="/cdn-cgi/l/email-protection#87c4c3c2d5aac8d7c3d7aad5d7cac7e1e3e6a9efeff4a9e0e8f1"><span class="__cf_email__" data-cfemail="387b7c7d6a1577687c68156a6875785e5c591650504b165f574e">[email protected]</span></a>.
With regard to human biological products: Anne Taylor, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.
With regard to the information collection: Domini Bean, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#752527342601141313351311145b1d1d065b121a03"><span class="__cf_email__" data-cfemail="4b1b190a183f2a2d2d0b2d2f2a65232338652c243d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Final Rule
B. Summary of the Major Provisions of the Final Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
A. Overview of Direct-to-Consumer Prescription Drug Advertising
and Its Regulation
B. History of the Rulemaking
C. Summary of Comments to the Proposed Rule
D. General Overview of Final Rule and Changes to the Proposed
Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
A. Introduction
B. General Comments
C. Research Studies--Comments and FDA Response
D. The Major Statement--Comments and FDA Response
E. Standards To Determine a Clear, Conspicuous, and Neutral
Manner--General Comments and FDA Response
F. Consumer/Audience--Comments and FDA Response
G. Proposed Standard #1 (Final Standard #1) (Language)--Comments
and FDA Response
H. Proposed Standard #2 (Final Standard #2) (Audio)--Comments
and FDA Response
I. Proposed Standard #3 (Final Standard #4) (Presentation of
Text)--Comments and FDA Response
J. Proposed Standard #4 (Final Standard #5) (Elements That
Interfere)--Comments and FDA Response
K. Dual Modality (Final Standard #3)--Comments and FDA Response
L. First Amendment Freedom of Speech--Comments and FDA Response
M. Role of Healthcare Professional--Comments and FDA Response
N. Costs--Comments and FDA Response
O. Enforcement--Comments and FDA Response
VI. Effective/Compliance Dates
VII. Economic Analysis of Impacts
A. Introduction
B. Summary of Costs and Benefits
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References
I. Executive Summary
A. Purpose of the Final Rule
This final rule implements a statutory requirement that in human
prescription drug advertisements presented directly to consumers in
television or radio format and stating the name of the drug and its
conditions of use (DTC TV/radio ads), the major statement relating to
side effects and contraindications (major statement) (Ref. 1) must be
presented in a clear, conspicuous, and neutral manner. (As used in this
document, unless specifically stated otherwise, references to DTC ads
and similar terms encompass ads for human prescription drugs only.) In
enacting that requirement, Congress directed FDA to issue regulations
establishing standards for determining whether a major statement is
presented in a clear,
[[Page 80959]]
conspicuous, and neutral manner. The final rule establishes five
standards that, independently and collectively, help ensure that the
major statement is presented in a clear, conspicuous, and neutral
manner. This rule does not change the content of the major statement.
This rule is an incremental addition to a longstanding body of
prescription drug advertising regulations. The statute and regulations
regarding DTC ads have long required that, with limited regulatory
exceptions, prescription drug ads include information about the
advertised drug's risks as well as its effectiveness. This final rule
complements the longstanding requirements for including risk
information in prescription drug ads, setting standards for the manner
of presentation of the major statement of side effects and
contraindications in DTC TV/radio ads to help ensure that this risk
information is presented effectively--that is, in a way that helps
consumers notice, attend to, and understand the drug's risks.
By helping consumers notice, attend to, and understand a drug's
risks, the final rule directly advances two substantial Government
interests. First, the measures required by the final rule help ensure
that DTC TV/radio ads convey a truthful and non-misleading net
impression about the advertised drug, including its risks. Second,
these measures help ensure that consumers are better informed when they
participate in healthcare decision making. Although prescription drugs
must be prescribed by a healthcare provider (HCP) and cannot be
accessed by consumers directly, consumers make decisions that have a
critical effect on health and well-being, such as whether to fill a
prescription, whether to initiate taking the prescribed drug, and
whether to continue taking the drug in adherence to a prescribed
regimen. The clear, conspicuous, and neutral presentation of risk
information in DTC TV/radio ads, in addition to benefit information,
helps ensure that these ads convey a truthful and non-misleading net
impression about the advertised drug and that consumers are better
informed when they participate in healthcare decision making.
B. Summary of the Major Provisions of the Final Rule
This final rule specifies five standards that, independently and
collectively, help ensure that the major statement is presented in a
clear, conspicuous, and neutral manner. The final rule establishes that
the information must be presented in consumer-friendly language and
terminology that is readily understandable. The audio information in
the major statement must be at least as understandable as the audio
information presented in the rest of the ad. In ads in TV format, the
information presented in the audio portion of the major statement must
also be presented concurrently in text for a sufficient duration to
allow it to be read easily. In ads in TV format, the information in
text must be formatted such that the information can be read easily.
The ad must not include audio or visual elements during the
presentation of the major statement that are likely to interfere with
comprehension of the major statement.
C. Legal Authority
This final rule amends FDA's prescription drug advertising
regulations to be consistent with the current requirements of the FD&C
Act, as amended by FDAAA, that in human prescription drug ads presented
directly to consumers in television or radio format and stating the
name of the drug and its conditions of use, the major statement
relating to side effects and contraindications shall be presented in a
clear, conspicuous, and neutral manner. In addition, FDAAA directed FDA
to establish standards for determining whether the major statement in
DTC TV/radio ads is presented in a clear, conspicuous, and neutral
manner--and does so in this rule. Furthermore, this rule is authorized
by various provisions of the FD&C Act.
D. Costs and Benefits
The benefits of this final rule stem from and include helping
consumers notice, attend to, and understand the major statement in DTC
TV/radio ads. The standards in the final rule help to ensure that DTC
TV/radio ads convey a truthful and non-misleading net impression about
the advertised drug and help ensure that consumers are better informed
when they participate in healthcare decision making. We discuss the
benefits qualitatively.
The costs of this final rule include the cost to read and
understand the rule, to revise a firm's \1\ standard operating
procedures, and to revise TV and radio ads during the transition period
leading up to the compliance date. We also expect there to be modest
ongoing costs for industry to review future DTC TV/radio ads to ensure
that these advertisements comply with this final rule and an ongoing
opportunity cost related to a potential change in the relative
allocation of time within the ad between the presentation of the major
statement and the presentation of other content. The total present
value of costs over a 10-year time horizon ranges from $104.8 million
to $331.8 million, with a primary estimate of $218.3 million, at a 7
percent discount rate; the present value ranges from $123.8 million to
$393.0 million, with a primary estimate of $258.4 million, at a 3
percent discount rate. Annualized costs over a 10-year time horizon
range from $14.9 million to $47.2 million, with a primary estimate of
$31.1 million, at a 7 percent discount rate; annualized costs over a
10-year time horizon range from $14.5 million to $46.1 million, with a
primary estimate of $30.3 million, at a 3 percent discount rate.
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\1\ In this document, ``firm'' refers to manufacturers, packers,
and distributors of prescription drugs and all of their
representatives, including both individuals and corporate entities.
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II. Table of Abbreviations/Commonly Used Acronyms in This Document
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Abbreviation/acronym What it means
------------------------------------------------------------------------
CBER......................... Center for Biologics Evaluation and
Research.
CDER......................... Center for Drug Evaluation and Research.
CFR.......................... Code of Federal Regulations.
CMP.......................... Civil Monetary Penalties.
DTC.......................... Direct-to-Consumer.
FDA.......................... United States Food and Drug
Administration.
FDAAA........................ Food and Drug Administration Amendments
Act of 2007.
FD&C Act..................... Federal Food, Drug, and Cosmetic Act.
FR........................... Federal Register.
FTC.......................... Federal Trade Commission.
HCP.......................... Healthcare provider, healthcare
professional, healthcare practitioner.
[[Page 80960]]
OMB.......................... Office of Management and Budget.
SUPERs....................... Superimposed text.
TV........................... Television.
U.S.C........................ United States Code.
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III. Background
A. Overview of Direct-to-Consumer Prescription Drug Advertising and Its
Regulation
American consumers encounter ads for an enormous variety of goods
and services, each ad seeking to attract their attention, pique their
interest, and ultimately drive demand for the advertised product or
service. But few ads provide information about products as important as
prescription drugs. Prescription drugs are integral to healthcare, and
decisions about their use can have critical effects on health and well-
being. These decisions about prescription drug use not only impact each
individual patient's health and well-being but also affect others,
including family, friends, and caregivers.
Of course, by definition, prescription drugs cannot be accessed
directly by consumers; they must be prescribed by a practitioner
licensed by law to administer such drugs (commonly referred to as a
healthcare professional, provider, or practitioner, here referred to as
HCPs). But the billions of dollars drug manufacturers spend annually to
promote their prescription drugs directly to consumers through TV ads
and other media demonstrate recognition that consumers make critical
choices related to treatment with prescription drugs. For example,
consumers decide whether to make an initial appointment with an HCP,
whether to ask the HCP about a particular drug, whether to fill a
prescription, whether to take the drug, and whether to continue taking
it in adherence to the prescribed regimen.
These decisions are informed by what consumers know about a drug,
starting with the most basic awareness of the drug's availability and
the health condition(s) for which it is approved. For U.S. consumers,
that knowledge is often derived from DTC ads, a major source of
information about human prescription drugs (Refs. 2 to 6). Analysis of
submissions by firms to FDA's Center for Drug Evaluation and Research
(CDER) of ads that the firms identify as DTC radio or TV ads, together
with spending data, illustrates the widespread use of these formats for
prescription drug advertising. For example, in 2007, when the clear,
conspicuous, and neutral manner requirement was enacted, firms
identified 74 new DTC radio ads in submissions to FDA's CDER, spending
$30 million on all prescription drug DTC radio ads in that year (Ref.
7). In 2020, firms identified 56 new DTC radio ads in submissions to
FDA's CDER, while spending on all prescription drug DTC radio ads
increased to $57.4 million for that same year (Ref. 8).
TV ads for prescription drugs are even more prevalent, and attract
enormous absolute and relative spending. In 2007, firms identified 434
new DTC TV ads in submissions to FDA's CDER, and the reported
expenditure for all prescription drug DTC TV ads in that year was $2.87
billion of a total of $4.77 billion spent on DTC advertising (Ref. 7).
In 2020, firms identified 564 new DTC TV ads in submissions to FDA's
CDER, and the reported expenditure for all prescription drug DTC TV ads
that year was $4.58 billion of a total of $6.58 billion spent on DTC
advertising (Ref. 9). While the number of TV ads has increased, a
published analysis of DTC TV ads found that ads in 2016 presented many
of the same elements (e.g., use of emotional appeals, focus on drug
benefits over health information) as ads in a 2004 analysis, indicating
a general consistency in such ads over time (Ref. 10).
Prescription drug firms have long maintained that their DTC ads
respond to consumer desire for information about prescription drugs
(Ref. 11). However, in light of their pervasiveness, consumers are
likely to be exposed to DTC TV/radio ads even if they are not actively
seeking information about any prescription drug.
Evidence shows that DTC ads inform important consumer decisions
about healthcare. For example, surveys indicate that DTC advertising
influences whether consumers seek more information about a drug, decide
to visit and discuss an advertised drug with an HCP, or decide not to
see an HCP (Refs. 12 to 17). This is one reason why Congress enacted
the requirement in section 502(n) of the FD&C Act addressed by this
final rule, requiring the major statement of side effects and
contraindications in DTC TV/radio ads to be presented in a clear,
conspicuous, and neutral manner. As one lead sponsor explained during
Senate floor consideration, a motivation for the legislation was
``[r]esearch . . . show[ing] that people are more likely to go to the
doctor, ask thoughtful questions, and discuss sensitive health issues
with their doctors as a result of DTC ads.'' See 153 Cong. Rec. S5631
(May 7, 2007) (statement of Sen. Roberts).
Like all advertisers, prescription drug firms have ample business
incentives to present their products in a positive light to potential
consumers. But those business incentives do not assure clear
communication of the advertised drug's negative attributes to
consumers. Firms' lack of business incentives, combined with DTC ads'
ability to inform and influence consumer participation in healthcare
decision making, points to the need for Government regulation of
prescription drug ads in particular. Ensuring that DTC ads that provide
benefit information about prescription drugs also effectively
communicate risk information is particularly important because the
effective presentation of risk information is critical to helping to
ensure that DTC TV/radio ads convey a truthful and non-misleading net
impression about the advertised drug, including its risks, and that
consumers are better informed when they participate in healthcare
decision making, as described elsewhere in this document. Further, the
consumer is uniquely positioned to know about particular, personal
circumstances or limitations (e.g., other medicines and supplements
being taken, constraints on time or other resources, allergies,
preferences) that are important factors in decision making about
prescription drug treatments. See Ref. 18 noting the changing role of
consumer as processor of health information. When taking into account
their own specific circumstances and what they know about a
prescription drug, a consumer decides whether they will accept
undesirable side effects in light of health benefits, whether they will
devote the necessary ongoing attention to monitoring and management to
optimize net outcomes, or even whether they need to avoid or prefer to
avoid a drug completely because the risks for that individual are too
great. As further explained below, the measures in this rule join other
longstanding
[[Page 80961]]
requirements that help remedy the lack of business incentive for
prescription drug firms to effectively communicate the risks of their
products to consumers, and thus, the standards established in this
rule, independently and collectively, advance the substantial
Government interests in helping to ensure that DTC TV/radio ads convey
a truthful and non-misleading net impression about the advertised drug
and that consumers are better-informed when they participate in
healthcare decision making.
1. Government Interests in This Regulation
For DTC TV/radio ads, the measures in this rule enhance the manner
of presentation of risk information to increase the likelihood that
consumers will notice, attend to, and understand the major statement in
these ads, which conveys the drug's major side effects and
contraindications. Improving consumer understanding of these risks
helps ensure that an ad conveys a truthful and non-misleading net
impression about the advertised drug. And improving consumer
understanding also helps ensure that consumers are better-informed when
they participate in healthcare decision making.
As the Supreme Court has recognized, ``there is no question that
[the Government's] interest in ensuring the accuracy of commercial
information in the marketplace is substantial'' (Edenfield v. Fane, 507
U.S. 761, 769 (1993)). Consistent with this overall interest for all
advertising, this rule helps ensure that DTC TV/radio ads communicate
risk so that they convey a truthful and non-misleading net impression
about the advertised drug. This purpose was also identified by an
author of the statutory provision underlying this regulation. See 153
Cong. Rec. S5631 (May 7, 2007) (statement of Sen. Roberts during floor
consideration) (``My amendment requires that major statements about a
drug's side effects, contraindications, and effectiveness in television
or radio ads be presented in a clear and conspicuous manner so as not
to mislead the public.''). In addition, although Federal law does not
prohibit DTC advertising of any legally marketed drug, research
indicates that some consumers erroneously believe that drugs that have
serious side effects cannot be advertised to consumers (Ref. 19). While
this rule does not change the content of the major statement in
prescription drug ads, presenting the major statement in a clear,
conspicuous, and neutral manner will help consumers understand if there
are serious risks associated with a drug. Thus, this rule seeks to help
ensure that DTC ads communicate risk information in a manner that helps
consumers notice, attend to, and understand the drug's risks.
The Government also has a substantial interest in promoting
consumer understanding of a prescription drug's risks in order to help
ensure that consumers are better informed when they participate in
healthcare decision making at each of the many important healthcare
decision points already described, taking account of their individual
circumstances. See, e.g., American Hosp. Ass'n v. Azar, 983 F.3d 528,
538 (D.C. Cir. 2020) (``providing consumers with factual price
information to facilitate more informed health care decisions'');
CTIA--The Wireless Ass'n v. City of Berkeley, 928 F.3d 832, 846 (9th
Cir. 2019) (informing consumers regarding radiation emissions from cell
phone and methods of avoiding excessive exposure); Discount Tobacco
City & Lottery, Inc. v. United States, 674 F.3d 509, 567 (6th Cir.
2012) (``effectively communicat[ing] the associated health risks [of
tobacco products] so that consumers possess accurate, factual
information when deciding whether to buy tobacco products''); Nat'l
Elec. Mfrs. Ass'n v. Sorrell, 272 F.3d 104, 115 (2d Cir. 2001)
(``increasing consumer awareness of the presence of mercury in a
variety of products'').
Ensuring that a drug's specific risks are effectively communicated
in DTC TV/radio ads helps inform consumers--another purpose identified
by an author of the legislation underlying this rulemaking. See 153
Cong. Rec. S5645 (May 7, 2007) (statement of Sen. Harkin) (stating that
the amendment seeks ``to help the FDA and the companies to provide
better information so that consumers can make real choices''). This
regulation, by helping to assure that ads that address a prescription
drug's benefits also facilitate understanding of risks, helps consumers
when they are exploring healthcare options.
Improving consumer understanding of an advertised prescription
drug's risks to better inform those consumers when they participate in
healthcare decision making is especially important in the American
healthcare environment. Evidence indicates that HCPs have limited time
with patients (Refs. 20 to 23) and discussions with patients are only
one among varied HCP duties that may include clinical care, research,
mentoring, teaching, electronic health recordkeeping, and other
administrative duties (Refs. 24 and 25). Moreover, as previously noted,
consumers have information about their individual circumstances that
may be relevant, or even critical, to any decision about use of a
particular prescription drug. Helping ensure consumers have the
information they need to formulate appropriate questions or bring up
relevant information about their personal circumstances during
interactions with HCPs helps consumers make productive use of those
interactions.
2. Consistency With Longstanding Statutory and Regulatory Measures
Regarding Prescription Drug Risk Presentation
The basic concepts of the rule continue the approach taken in many
longstanding measures applicable to prescription drug advertising and
labeling. For example, since 1938 (for labeling) and 1976 (for
advertising), section 201(n) of the FD&C Act has reflected the
principle that disclosing material facts that include the
``consequences'' of using the drug to which labeling or advertising
relates is key to ensuring that such communications are not misleading.
Moreover, the more precise principle that when drug manufacturers
choose to advertise prescription drugs, those ads must provide risk
information was recognized with the 1962 enactment of section 502(n) of
the FD&C Act, specifying that prescription drug ads must include ``a
true statement of. . .other information in brief summary relating to
side effects, contraindications and effectiveness as shall be required
in regulations . . . .'' Accordingly, a specific regulatory requirement
to convey a prescription drug's risks in its advertising has been in
place since 1963. See 28 FR 6375 at 6376 (June 20, 1963). And since
1969, the prescription drug advertising regulations have specifically
addressed the use of a statement of the advertised drug's major side
effects and contraindications in TV and radio advertising. See 34 FR
7802 (May 16, 1969). Similarly, many drug firms have also long
acknowledged that DTC ads that convey benefit information should also
contain risk information (Ref. 11).
After industry's initial forays into DTC prescription drug
advertising in the early 1980s, FDA confirmed that DTC advertising was
likewise subject to these established prescription drug advertising
regulations. See 50 FR 36677 at 36678 (September 9, 1985) and Sec.
202.1(e)(1) (1985). This was the regulatory framework that was in place
in 2007, when Congress amended the
[[Page 80962]]
underlying statutory provision in section 502(n) of the FD&C Act to
codify the importance of ads effectively communicating risk to
consumers by further specifying that this ``major statement relating to
side effects and contraindications'' in human prescription drug
advertisements presented directly to consumers in television or radio
format and stating the name of the drug and its conditions of use, be
presented in a clear, conspicuous, and neutral manner.
The specific ``clear, conspicuous, and neutral manner'' provision
that this regulation addresses is also part of a longstanding line of
statutory and regulatory provisions that help ensure that an inadequate
manner of presentation does not undermine required disclosures about
prescription drugs. See, e.g., 21 U.S.C. 352(c) (enacted by Pub. L. 75-
717 (June 25, 1938)), establishing misbranding if prominence,
conspicuousness, and terms used to present required elements of
labeling for drugs and devices are not sufficient to ``render it likely
to be read and understood by the ordinary individual under customary
conditions of purchase and use.'' In fact, provisions for presenting
required information clearly and prominently have been a part of
requirements for prescription drug advertising since the first such
regulations were issued. See 28 FR 6375 at 6377 (initial regulations
issued under section 502(n) of the FD&C Act, including 21 CFR 1.105(i),
requiring information concerning side effects and contraindications to
appear ``in reasonably close association with the information
concerning effectiveness'' with ``the same relative degree of
prominence as the information concerning effectiveness, taking into
account all pertinent factors, including typography, layout, contrast,
and other printing features.''); see also current Sec.
202.1(e)(7)(viii).
This rulemaking complements these longstanding prescription drug
advertising requirements. This rule brings additional clarity to
existing provisions about the major statement in DTC TV/radio ads by
providing information on how that major statement must sound and (in
the case of TV ads) look.
In sum, this rulemaking is an important incremental measure, adding
to a longstanding body of legal requirements addressing effective
communication of risk information about prescription drugs in consumer-
directed promotional communications. The rule helps ensure that DTC TV/
radio ads convey a truthful and non-misleading net impression about the
advertised drug and helps ensure that consumers are better informed
when they participate in healthcare decision making.
B. History of the Rulemaking
In the proposed rule (Federal Register of March 29, 2010 (75 FR
15376)), we proposed to amend our regulations regarding DTC TV/radio
ads in accordance with section 901(d)(3) of FDAAA (see 21 U.S.C.
352(n)). Specifically, we proposed to implement provisions of FDAAA
requiring that in human prescription drug advertisements presented
directly to consumers in television or radio format and stating the
name of the drug and its conditions of use, the major statement
relating to side effects and contraindications shall be presented in a
clear, conspicuous, and neutral manner.
We proposed the following four standards for determining whether
the major statement in these ads is presented in the statutorily
required manner:
#1. Information is presented in language that is readily
understandable by consumers.
#2. Audio information is understandable in terms of the volume,
articulation, and pacing used.
#3. Textual information is placed appropriately and is presented
against a contrasting background for sufficient duration and in a size
and style of font that allows the information to be read easily.
#4. The advertisement does not include distracting representations
(including statements, text, images, or sounds or any combination
thereof) that detract from the communication of the major statement.
We also solicited comment on a potential fifth standard to require
that in TV ads, the major statement be presented simultaneously in both
audio and visual portions of the ad--a practice known as dual modality.
In developing these proposed standards, FDA considered standards
developed by other Federal Agencies, including the Federal Trade
Commission (FTC), the Department of the Treasury, the Commodity Futures
Trading Commission, and the Securities and Exchange Commission, for
determining whether disclosures in TV/radio ads, as well as disclosures
in other contexts, are ``clear and conspicuous'' (75 FR 15376 at 15377-
15379). Then, as now, the Agency considered these standards to be
highly relevant because they aim to ensure that required disclosures
are effectively presented so that consumers are not misled about the
attributes of the product or service that is the subject of the
communication. As discussed in section III.A.1 of this document, FDA
has a similar interest in ensuring that DTC TV/radio ads convey a
truthful, non-misleading net impression about the advertised drug.
FDA noted in the preamble of the proposed rule that these other
Federal standards revealed the widespread incorporation of common
themes, which FDA in turn incorporated in its own proposed standards,
and now incorporates in its final standards, because they are all
factors that contribute to whether the audience will notice, attend to,
and understand the risk information in the major statement (75 FR 15376
at 15378-15379). These themes were: ``ease of comprehension of the
language used in the disclosure; the formatting and location of textual
information in the disclosure; audio considerations such as pacing,
volume, and qualities of speech; and the presence of any distracting
elements during the disclosure'' (75 FR 15376 at 15378). The language
of the standards from other Federal Agencies cited in the proposed rule
and the themes incorporated by those other Federal standards remain
unchanged.\2\
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\2\ The definition of ``clear and conspicuous'' in one
regulation cited in the proposed rule, 12 CFR 40.3, is now part of
12 CFR 1016.3.
---------------------------------------------------------------------------
In the proposed rule, FDA also noted that its proposed standards
were consistent with factors described and discussed in its draft
guidance entitled ``Presenting Risk Information in Prescription Drug
and Medical Device Promotion'' (May 2009) (draft Risk Guidance; Ref.
26) (available at <a href="https://www.fda.gov/media/76269/download">https://www.fda.gov/media/76269/download</a>) (75 FR
15376 at 15379). That draft guidance reflects consideration of a broad
body of social science research into human cognition and factors that
impact attention and comprehension.
The Agency also noted in the proposed rule that it was unaware of
any previous standards or regulations concerning the definition of
``neutral manner'' in the context of required disclosures but
considered ``neutral manner'' to mean ``unbiased manner'' of
presentation and thus proposed standards accordingly. The Agency
suggested, ``To achieve a `neutral,' unbiased presentation of the major
statement and to avoid undercutting its effectiveness, the major
statement must not be presented in competition with other elements if
these elements would arrest the attention and distract consumers from
the presentation of the risk information'' (75 FR 15376 at 15380). As
part of the overall
[[Page 80963]]
establishment of standards for effectively communicating necessary risk
information in a clear, conspicuous, and neutral way, we requested
comments on standards to establish what is ``neutral'' (75 FR 15376 at
15380).
In the proposed rule (75 FR 15376 at 15379), we noted that FDA had
conducted a study on the impact of certain types of visual distraction
on consumer understanding of risk and benefit information in DTC TV ads
for prescription drugs (referred to in this document as the Distraction
Study), the results of which were at that time still undergoing
analysis (and, consequently, were not the basis of any specific
provision in the proposed rule). FDA acknowledged the limitations of
this study, but because FDA believed it could be relevant to the
rulemaking, announced plans to place the report of the results into the
docket for the proposed rule with opportunity for comment. Accordingly,
in the Federal Register of January 27, 2012 (77 FR 4273), we announced
the addition of the Distraction Study report to the docket (Ref. 27),
and we reopened the rulemaking comment period until February 27, 2012,
to provide an opportunity for interested parties to comment on the
study as it relates to the proposed standards (Docket No. FDA-2009-N-
0582). In the Federal Register of March 29, 2012 (77 FR 16973), we
reopened the comment period for the rulemaking proceeding again until
April 9, 2012, in response to a request for more time to submit
comments to the Agency on the Distraction Study report as it related to
the proposed standards.
The Distraction Study examined three factors that might influence
viewers' understanding of the risk information presented in the audio
portion of a TV ad. This research evaluated the effects of:
<bullet> Presence or absence of superimposed text (SUPERs) that
concurrently presented verbatim, key words and phrases from the audio
presentation of risk;
<bullet> Variations in the positive (affective) tone of visual
images; and
<bullet> Visual information that was either inconsistent or
consistent with the audio risk information.
The results of the Distraction Study indicate that presenting the
same risk information visually (i.e., in SUPERs) and in audio at the
same time (dual modality) improves consumers' understanding of the risk
information. The Distraction Study did not find support for the
hypotheses that understanding of the risk information is adversely
influenced by concurrently presenting positively toned visual images or
by concurrently presenting information in visuals that is inconsistent
with the risk information presented in audio (Ref. 27). While the
Distraction Study and its results were a consideration during the
formulation of the standards in this final rule, they were neither the
sole justification for, nor the only information considered in, the
development of any of the proposed or final standards.
FDA based the standards in the proposed rule on scientific
research, literature, and existing Government standards, all of which
continue to be relevant for the final rule. Research findings
supporting the proposed rule's standards--including research findings
on dual modality and distraction--were available during the public
comment periods and have been subsequently corroborated by additional
research, including research supporting that comprehension and recall
is increased when information is provided in both audio and text and
also when information is presented without distraction. In this final
rule, the fundamental concepts remain the same as those articulated in
the proposed rule. Evolving technologies have allowed for DTC TV/radio
ads to be presented on a broader range of devices and disseminated via
a broader range of platforms since the issuance of the proposed
rule.\3\ However, from an informal review of ads firms recently
submitted to FDA in accordance with regulatory requirements (21 CFR
314.81(b)(3)(i) and 601.12(f)(4)), FDA observes that firms have not
developed distinct ads for dissemination on these new devices and
platforms and that DTC TV/radio ads remain essentially the same.
Moreover, fundamental attributes of communication that impact the
likelihood that audiences will notice, attend to, and comprehend
information, which the standards in the proposed and final rules
concentrate on, do not turn on the delivery technology.
---------------------------------------------------------------------------
\3\ See, e.g., Ipsos, ``Half of American TV viewers watch 10 or
more hours of TV during the week,'' Report, July 28, 2021, available
at <a href="https://www.ipsos.com/en-us/news-polls/american-tv-viewing-habits-2021">https://www.ipsos.com/en-us/news-polls/american-tv-viewing-habits-2021</a>, accessed September 7, 2023; Leiner, D.J. and N.L.
Neuendorf, ``Does Streaming TV Change Our Concept of Television?''
Journal of Broadcasting & Electronic Media, 66(1):153-175, 2022.
doi:10.1080/08838151.2021.2013221; Radioworld, ``How Technology
Helps Radio and Its Listeners,'' April 9, 2019, available at <a href="https://www.radioworld.com/columns-and-views/guest-commentaries/rab-audio-technology-helps-radio">https://www.radioworld.com/columns-and-views/guest-commentaries/rab-audio-technology-helps-radio</a>, accessed September 7, 2023.
---------------------------------------------------------------------------
We recognize the passage of time between the closure of the last
comment period on the proposed rule and the issuance of this final
rule, which resulted in large part from competing demands for limited
Agency resources, such as repeated redirection of personnel into
emergency operations for natural disasters, the opioid epidemic, and
infectious disease outbreaks including Ebola, Zika, and the COVID-19
pandemic. Despite this passage of time, FDA concludes that this
rulemaking is both procedurally and substantively sound. A central
purpose of notice-and-comment rulemaking is to obtain public input, see
Make the Rd. N.Y. v. Wolf, 962 F.3d 612, 634 (D.C. Cir. 2020) and
United States v. Cain, 583 F.3d 408, 420 (6th Cir. 2009). The Agency
has provided three public comment periods, offering meaningful
opportunities for any interested persons to comment on the rulemaking
and the bases for the standards laid out in this rulemaking.\4\ Indeed,
no parties have requested additional opportunity for comment since
closure of the last comment period, even though the Agency's plans to
issue a final rule have been consistently made public through the
Unified Agenda since 2017. Moreover, as noted above, the Agency has
determined that there are no material changes in the fundamental
concepts, relevant facts (including evolving technologies), scientific
research, literature, or existing Government standards underlying the
rule. For these reasons, FDA concludes that it is appropriate to issue
this final rule without offering a fourth opportunity for public
comment.
---------------------------------------------------------------------------
\4\ See also Little Sisters of the Poor Saints Peter & Paul Home
v. Pennsylvania, 140 S. Ct. 2367, 2385, (2020) (The Administrative
Procedure Act (APA) prescribes the ``maximum procedural requirements
that an agency must follow in order to promulgate a rule.'')
(internal quotation marks omitted); Sanofi-Aventis US LLC v. HHS, 58
F.4th 696, 706 (3d Cir. 2023) (``all the APA requires of an agency
before publishing a final rule is (1) putting a notice of proposed
rulemaking in the Federal Register, (2) accepting comments on that
proposal, and (3) considering those comments. See 5 U.S.C. 553(b)-
(c).'')
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C. Summary of Comments to the Proposed Rule
There were three public comment periods for the proposed rule. In
total, FDA received over 70 submissions from consumers, public interest
or consumer groups, trade and industry associations, healthcare
providers, and drug firms. Overall, the majority of comments express
support for the proposed rule. Several comments request that FDA edit
the proposed rule, provide clarification, or provide more detail.
Several comments suggest that FDA undertake additional research before
finalizing the rule. We address these and other comments throughout
this document.
[[Page 80964]]
D. General Overview of Final Rule and Changes to the Proposed Rule
This final rule implements a FDAAA requirement (codified in 21
U.S.C. 352(n)) that in human prescription drug advertisements presented
directly to consumers in television or radio format and stating the
name of the drug and its conditions of use, the major statement
relating to side effects and contraindications shall be presented in a
clear, conspicuous, and neutral manner. This statutory requirement has
been in effect since March 25, 2008. In line with other Government
standards, findings from scientific research and literature, and the
proposed rule, this final rule establishes standards for determining
whether the major statement in these ads is presented in a clear,
conspicuous, and neutral manner.
We discuss the following:
<bullet> In the final rule, we do not address ``neutral''
separately from the overall concept of a ``clear, conspicuous, and
neutral manner'' of presentation, nor do we associate that attribute
exclusively with any single standard. Rather, we conclude that the
final standards, independently and collectively, contribute to a clear,
conspicuous, and neutral manner of presentation.
<bullet> Proposed standard #1 (final standard #1; Sec.
202.1(e)(1)(ii)(A)): ``Information is presented in language that is
readily understandable by consumers.'' The final standard specifies
that the major statement must be presented in consumer-friendly
language and terminology that is readily understandable.
<bullet> Proposed standard #2 (final standard #2; Sec.
202.1(e)(1)(ii)(B)): ``Audio information is understandable in terms of
the volume, articulation, and pacing used.'' The final rule clarifies
that the audio information in the major statement must be at least as
understandable as the audio information presented in the rest of the ad
in terms of the volume, articulation, and pacing used.
<bullet> Proposed potential standard #5 (final standard #3; Sec.
202.1(e)(1)(ii)(C)): The final rule includes a standard requiring that
for ads in TV format, the major statement be presented concurrently
using both audio and text (dual modality). To achieve dual modality:
(1) either the text displays the verbatim key terms or phrases from the
corresponding audio, or the text displays a verbatim complete
transcript of the corresponding audio; and (2) the text is displayed
for a sufficient duration to allow it to be read easily. For the
purposes of this standard, the duration is considered sufficient if the
text display begins at the same time and ends at approximately the same
time as the corresponding audio.
<bullet> Proposed standard #3 (final standard #4; Sec.
202.1(e)(1)(ii)(D)): ``Textual information is placed appropriately and
is presented against a contrasting background for sufficient duration
and in a size and style of font that allows the information to be read
easily.'' The final rule removes the duration requirement from this
standard, including it instead in final standard #3, and clarifies that
this standard applies to the text portion of the major statement in ads
in television format. For clarity, we also reorganized the phrasing of
this standard.
<bullet> Proposed standard #4 (final standard #5; Sec.
202.1(e)(1)(ii)(E)): ``The advertisement does not include distracting
elements (including statements, text, images, or sounds or any
combination thereof) that detract from the communication of the major
statement.'' The final rule revises the standard to specify that, in
order to satisfy it, during presentation of the major statement, the ad
does not include audio or visual elements, alone or in combination,
that are likely to interfere with comprehension of the major statement.
We also made the following non-substantive editorial changes on our
own initiative:
<bullet> Section 202.1: Relocated text that defines prescription
drug for purposes of this section (previously included in Sec.
202.1(e)(1)). Within this definition, replaced the phrase ``drugs for
use by man'' with the phrase ``drugs intended for use by humans.''
<bullet> Section 202.1(e): Divided information into subordinate
paragraphs for clarity, ease of reading, and plain language.
<bullet> Section 202.1(e)(1)(i): Added subparagraphs for ease of
reading and reference to Sec. 202.1(e)(1)(ii)(C) for clarity. Replaced
``approved or permitted package labeling'' with ``approved or permitted
product labeling.''
<bullet> Section 202.1(e)(1)(ii): Revised introductory language to
reflect that it is the manner of presentation of the major statement
that is ``clear, conspicuous, and neutral,'' if the standards that
follow are met.
IV. Legal Authority
This final rule amends Sec. 202.1 to be consistent with the
current requirements of section 502(n) of the FD&C Act, as amended by
section 901(d)(3) of FDAAA, which establishes a requirement that in
human prescription drug ads presented directly to consumers in
television or radio format and stating the name of the drug and its
conditions of use, the major statement relating to side effects and
contraindications shall be presented in a clear, conspicuous, and
neutral manner. In addition, FDA was directed by FDAAA (see section
901(d)(3)(B)) to establish standards for determining whether the major
statement in DTC TV/radio ads is presented in a clear, conspicuous, and
neutral manner--and does so in this rule. Furthermore, this rule is
authorized by various statutory provisions, including sections 201,
301, 502, 505, 512, and 701 of the FD&C Act.
V. Comments on the Proposed Rule and FDA Response
A. Introduction
During the initial comment period (March 29 to June 28, 2010), FDA
received more than 30 submissions on the proposed rule from consumers,
public interest groups, trade associations, and the drug industry. When
we reopened the comment period to allow for comment on the Distraction
Study report as it relates to the proposed standards (January 27 to
February 27, 2012, and March 29 to April 9, 2012), we received nearly
40 additional submissions.
In sections V.B through V.O of this document, we describe the
comments received on the proposed rule and provide our responses. To
make it easier to identify the comments and our responses, the word
``Comment,'' in parentheses, appears before the comment's description,
and the word ``Response,'' in parentheses, appears before our response.
We have numbered each comment to help distinguish between different
comments. We have grouped similar comments together under the same
number and, in some cases, we have separated different subjects
discussed in the same comment and designated them as distinct comments
for purposes of our responses. The number assigned to each comment or
comment topic is purely for organizational purposes and does not
signify the comment's value or importance or the order in which
comments were received. We reviewed all comments and carefully
considered all points and perspectives. However, comments not directly
relevant to this rulemaking were read and considered but are not
discussed in this document.
B. General Comments
The majority of comments, including input from industry, support
the proposed rule, while only a few comments oppose the rule. Several
[[Page 80965]]
comments indicate that the proposed rule was an important first step,
but even more needs to be done, and some suggest that FDA needs
additional information or research results before the regulation is
finalized. Various other comments request clarification on certain
issues in the proposed rule. We address these and other comments
throughout this document.
C. Research Studies--Comments and FDA Response
In the proposed rule, FDA referenced a number of research studies
relevant to the proposed standards generally and to dual modality
specifically, and also referenced the Agency's draft Risk Guidance,
which itself describes a well-established body of social science
research relevant to the standards in the proposed and final rule. As
previously described, FDA also mentioned the Distraction Study in the
proposed rule, although its results were still undergoing analysis at
that time, and indicated that FDA intended to add the study report to
the docket for the rulemaking when available and provide opportunity
for public comment, as FDA believed those study results might provide
helpful information to consider in the rulemaking. FDA subsequently
provided two opportunities for the public to comment on the results and
FDA's analyses of the study and how it related to the proposed
standards (77 FR 4273 and 77 FR 16973). Many of the comments discuss
how the Distraction Study relates to the proposed standards. Several
comments conclude that the results of the study directly support the
proposed rule. However, several other comments argue that the study
design was flawed or did not support the proposed rule. Several
comments suggest that additional research should be conducted regarding
distraction and the understanding of risk information by consumers.
Comments on the results of the Distraction Study as it relates to
proposed standard #4 regarding distracting elements that detract from
the communication of the major statement are addressed in section V.J
of this document (final standard #5).
Comments pertaining to the use of dual modality in the Distraction
Study are addressed in section V.K of this document.
However, we briefly address several general comments related to the
Distraction Study and other research here.
(Comment 1) Several comments suggest that the Distraction Study did
not examine a sufficient number of factors regarding consumers'
understanding of risk information. One comment notes that the
Distraction Study did not examine all four proposed standards to
determine what would be considered clear, conspicuous, and neutral.
Another comment points out that there are many factors beyond those
studied that affect the assessment of risk. This comment suggests that
FDA should examine how individual perception of risk is influenced by
personal experiences, education level, race, gender, age, and knowledge
of the agent creating the risk.
Another comment states that the Distraction Study failed to address
the full context in which the benefits and risks of prescription drugs
are actually considered, specifically with respect to the doctor-
patient relationship. The comment argues that doctor-patient
interaction is an integral part of the communication of benefits and
risks for prescription drugs and thus must be considered in any
assessment regarding risk communication. The comment suggests
additional studies be conducted, including: (1) studies that measure
the effect of DTC ads on the quality of any subsequent discussions
between the patient and physician and (2) studies that measure
comprehension of benefits and risks only after consultation with a
physician.
One comment suggests that FDA should consider additional research
to determine the elements of advertising that may distract a viewer's
attention from the major statement. Another comment notes that no study
can account for all possible distractions consumers might face.
(Response 1) Many of these comments appear to overstate the role of
the Distraction Study with regard to the development of the standards
for a clear, conspicuous, and neutral presentation of the major
statement. We conclude that there is a strong basis for the final rule
without the Distraction Study or the additional research that some
comments suggest be conducted.
The Distraction Study was designed only to examine the effects of
three particular, pre-defined factors: the presence or absence of
SUPERs that concurrently presented verbatim, key words and phrases from
the audio presentation of risk; variations in the positive (affective)
tone of visual images; and visual information that was either
inconsistent or consistent with the audio risk information. Consistent
with the limitations of the Distraction Study, which FDA acknowledged
in the proposed rule (see 75 FR 15376 at 15379), neither the proposed
nor final standards for ``clear, conspicuous, and neutral manner'' of
presentation of the major statement are contingent on its results.
Indeed, a much larger body of social science research, together
with disclosure standards of other Federal agencies and ordinary
experience with situations where multiple factors compete for attention
and may affect comprehension, informs the proposed and final standards
for a clear, conspicuous, and neutral manner of presentation of the
major statement. For example, the Agency's draft Risk Guidance,
referenced in the proposed rule as describing factors consistent with
the proposed rule's standards (75 FR 15376 at 15379), included
cognitive science research that predated the Agency's Distraction Study
and demonstrated that, while there is some variation based on
expertise, all people have limits on the amount of information they can
think through and process at one time (see draft Risk Guidance, at p. 6
and fn. 20 (in this rule, Refs. 28-30)). Further, the draft guidance
notes that to process information, a person must first pay attention to
it. The guidance then goes on to discuss multiple factors (with
underlying research) that contribute to whether people will pay
attention to information, including formatting factors. Among other
things, the draft guidance points to the well-established body of
research that existed at the time of the proposed rule--and has been
further corroborated since that time--that various elements can
interfere with attention and comprehension. See, e.g., draft guidance
p. 18, fn. 47 (in this rule, Refs. 31-33); p. 19, fns. 54 to 56 (in
this rule, Refs. 34-36); and p. 20, fn. 61 (in this rule, Ref. 37).
References cited in the Distraction Study report that was added to the
docket for this rulemaking and made available for public comment
include additional research on well-documented distracting effects of
certain other elements. (See Distraction Study report, p. 3, fn. 1,
citing research on scene changes (in this rule, Ref. 38) and music (in
this rule, Ref. 39).) Similar information about social science research
relevant to other aspects of proposed standards #1 through #4 also
appears in the draft Risk Guidance, which the proposed rule itself
references. The public had the opportunity to comment on the rule and
the Agency's use of the guidance and research to inform the proposed
standards. That research remains relevant to this final rule. The
proposed and final standards also have a basis in disclosure standards
of other Federal agencies (cited in the proposed rule and unchanged
since) and ordinary
[[Page 80966]]
experience with situations where multiple factors compete for attention
and may affect comprehension. As to dual modality, the proposed rule
summarized a substantial body of research supportive of the utility of
this technique, predating the Distraction Study (75 FR 15376 at 15383).
As discussed in section V.K of this document, findings of this research
regarding the positive impact of dual modality have been corroborated
subsequently by the Distraction Study and other research.
Other comments submitted to the docket for the final rule discuss
technical details of the Distraction Study's methodology and analyses,
rather than the standards in the rule. Sections V.J and V.K of this
document address non-technical comments related to the Distraction
Study's methodology as it relates to final standard #3 (section V.J)
and final standard #5 (section V.K). However, because the Distraction
Study was only one of many pieces of information FDA considered when
formulating the standards for this rule, technical comments on the
study methodology are not further discussed here.
(Comment 2) One comment recommends that FDA develop strategies to
ensure consumer understanding of the information contained in DTC ads,
such as using patient focus groups to pre-approve the most common risk
statements. Additionally, the comment suggests that other elements,
such as font size, color, and placement, should be tested with
consumers. The comment further suggests that FDA should conduct
research to provide an evidence-based assessment of the proposed
standards to ensure that they result in consumer-directed ads that
effectively communicate risk in a clear, conspicuous, and neutral way.
The comment concludes that this research would allow FDA to use
quantitative, documented evidence, rather than relying on the consensus
of expert opinion.
Two comments also suggest that FDA should consider conducting
research and a further analysis on how individual elements combined and
presented together would affect the overall communication of the
advertised drug's potential benefits and associated risks. A separate
comment suggests that the communication of benefits and risks in DTC
ads should be tested on an ad-to-ad basis against quantitative
standards for evaluating comprehension and understanding among the
intended audience.
(Response 2) As part of the rulemaking process culminating in the
standards in this final rule, FDA considered many resources, including
the many comments submitted during the multiple comment periods, and
the literature, research, and other Government standards described
elsewhere in this document. In light of the consistency of findings in
the research evaluating the presentation of risk information in DTC ads
for prescription drugs from the time of the proposed rule through now,
as well as the other Federal Government standards for clear and
conspicuous disclosures of information cited in the proposed rule and
still in place today, we conclude that we have sufficient information
to finalize this regulation without additional research.
D. The Major Statement--Comments and FDA Response
In proposed Sec. 202.1(e)(1)(i), FDA proposed to add the term
``major statement'' in parentheses after the phrase ``major side
effects and contraindications'' to reflect the Agency's interpretation
that this is the meaning of the terminology used in section 502(n) of
the FD&C Act as amended, an interpretation consistent with previous
usage (see 75 FR 15376 and 15379; Ref. 1). We did not receive comments
directly on this proposal and our final rule includes this provision
for the same reasons we proposed it. We did receive comments and
questions about the major statement in general.
(Comment 3) One comment suggests that FDA should incorporate the
concept of ``net impression'' (the message communicated by all elements
of the piece as a whole) by adding the following language to the end of
proposed Sec. 202.1(e)(1)(i): ``The adequacy of the major statement
will be determined not just in relation to risk-related statements, but
by the net impression of the advertisement as a whole.''
(Response 3) We disagree with adding the suggested language.
Although both the major statement and other components of the ad
collectively contribute to the overall net impression, under section
502(n) of the FD&C Act, the requirement that certain information be
presented in a ``clear, conspicuous, and neutral manner'' applies
specifically to ``the major statement relating to side effects and
contraindications''--not to the ad as a whole. Because this requirement
is specific to the presentation of the major statement, a failure to
satisfy this requirement cannot be remedied by the presentation of
statements in other portions of the ad. For this reason, we decline to
add the proposed language, which would allow for the interpretation
that an inadequately presented major statement can be made adequate by
statements in other parts of the ad.
FDA will, however, continue to evaluate the net impression created
by a DTC TV/radio ad in determining whether that ad is false or
misleading. FDA considers net impression as well as evaluates specific
risk-related statements in these ads. It is consistent with this
approach to issue regulations that recognize the need for the major
statement to satisfy, on its own, specific statutory requirements.
Furthermore, presenting the major statement in a clear, conspicuous,
and neutral manner should help ensure DTC TV/radio ads convey a
truthful and non-misleading net impression about the advertised drug.
(Comment 4) One comment recommends that the rule specify the
location of the major statement in the ad. This comment suggests that
the major statement should not appear in the middle of the ad ``where
it can be bookended by benefit information and is least likely to be
retained by consumers.''
(Response 4) We decline to include in the final rule a provision
specifying exactly where the major statement must appear in the ad.
This final rule's standards for presenting the major statement in a
clear, conspicuous, and neutral manner complement, rather than
displace, FDA's longstanding approach to assessing whether the ad as a
whole complies with other requirements. To ensure that the ad provides
fair balance between information relating to side effects and
contraindications and information relating to effectiveness of the
drug, and to assess whether it conveys a truthful and non-misleading
net impression about the advertised drug, FDA already considers the
placement of risk information together with many other elements of the
piece, including framing, signaling, themes, and other risk
presentation factors.
E. Standards To Determine a Clear, Conspicuous, and Neutral Manner--
General Comments and FDA Response
In this final rule, as directed by FDAAA, FDA establishes standards
for determining whether the major statement in DTC TV/radio ads is
presented in a clear, conspicuous, and neutral manner as required by
section 502(n) of the FD&C Act. (Of five final standards, two apply
only to ads in television format.)
[[Page 80967]]
Although we believe that the five standards established by this
rule, when applied collectively, will best help ensure that the major
statement in a DTC TV/radio ad is presented in a clear, conspicuous,
and neutral manner, each standard independently enhances the manner of
presentation to increase the likelihood that consumers will notice,
attend to, and understand the advertised drug's major side effects and
contraindications. In the event of a stay or invalidation of any
standard(s), those that remain in effect would continue to function
sensibly \5\ to advance these statutory objectives and provide useful
standards for firms to meet their existing statutory obligation. For
example, invalidation of a standard that addresses visual aspects of
presentation would have no effect on standards addressing audio aspects
or terminology. Likewise, in the absence of final standard #3 (dual
modality) or final standard #5 (audio or visual elements that are
likely to interfere with comprehension), each of the other standards
would continue to contribute to a clear, conspicuous, and neutral
manner of presentation of the major statement. Therefore, it is FDA's
intent to preserve each of the rule's standards to the fullest possible
extent, to help advance the important Government interests described in
section III.A.1.
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\5\ See, e.g., Belmont Mun. Light Dep't v. FERC, 38 F.4th 173,
188 (D.C. Cir. 2022) (finding severability of a portion of an
administrative action, applying the principle that severability is
appropriate where ``the agency prefers severability to overturning
the entire regulation'' and where the remainder of the regulation
``could function sensibly without the stricken provision'')
(citations omitted).
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As noted in section III.B of this document, in the proposed rule,
FDA stated that it was unaware of any previous standards or regulations
concerning the definition of ``neutral manner'' in the context of
required disclosures and requested comment on this topic. In addition,
in conjunction with proposed standard #4, FDA stated, ``To achieve a
`neutral,' unbiased presentation of the major statement and to avoid
undercutting its effectiveness, the major statement must not be
presented in competition with other elements if these elements would
arrest the attention and distract consumers from the presentation of
the risk information'' (75 FR 15376 at 15380). However, FDA did not
intend to suggest that the ``neutral'' element of the statutory
requirement is only explained by or only relates to proposed standard
#4, nor did we intend to foreclose the possibility that the other
standards contribute to achieving a manner of presentation that is
neutral as well as clear and conspicuous. We received comments
suggesting ways in which ``a neutral manner'' could be explained
through the other standards. To the extent that comments discuss
neutrality specifically with respect to any of the five final
standards, we discuss the comments within the sections that address
those standards.
(Comment 5) One comment supports the maintenance of a neutral tone
in DTC ads to ensure that consumers are able to glean as much
information about risk as possible. One comment asks FDA to confirm
that ``neutral'' relates to the way in which the ad presents the major
statement as opposed to the substantive content of the major statement.
Another comment suggests that neutrality means that the major statement
should only include FDA-approved uses and some measure of the risks of
potential side effects.
One comment argues that neutrality has nothing to do with
distraction and suggests that Congress intended to incorporate a
different meaning of neutrality because it had the opportunity to
require that the major statement be totally devoid of all potentially
distracting information by mandating that it be in plain black-and-
white or ``tombstone'' format. This comment also notes that the
definition of ``neutral'' from Black's Law Dictionary is ``indifferent;
unbiased; impartial; not engaged on either side; not taking an active
part with either of the contending sides.'' The comment states that a
DTC ad in TV/radio format is qualitatively neutral if it neither under-
warns consumers about the major risks nor overly deters consumers from
using a beneficial product. Thus, the comment concludes that neutral
should relate to the content or substance of an ad and not the style or
manner in which the content is presented.
Furthermore, within a discussion about neutrality, the same comment
notes that a DTC TV/radio ad that overemphasizes risks is potentially
as misleading as one that overemphasizes benefits. Several other
comments express similar views. One of these comments states that how
consumers feel about prescription medications and the impressions they
have regarding the safety of these products can affect appropriate use
of the products. The comment also notes that the company's research
suggests that adherence to a prescribed medication is based on three
factors: (1) concerns about the drug (i.e., short- and long-term
risks), (2) perceived need for the drug, and (3) concerns about drug
cost. Another comment encourages FDA to further consider issuing
standards to clarify what could be a subjective concept open to issues
of interpretation and meaning. This comment encourages FDA to evaluate
through research with target audiences whether an ad is balanced in the
presentation of benefits and risks and whether serious risk information
in ads is understood.
Another comment suggests that a broad definition of ``neutral''
should be adopted. The comment proposes that to present information
``neutrally'' DTC advertisements should compare the advertised
product's risks with the expected benefits (including considerations
relating to consumer convenience, comfort, cost, and expected
benefits); compare the safety and efficacy of the advertised product
with other products for the same indication (e.g., existing products
both under patent and generic); and compare the safety and efficacy of
the advertised product with non-pharmaceutical approaches for the same
indication (e.g., lifestyle modifications). This comment claims that
including this information will result in a more neutral presentation
by giving consumers a balanced picture of the benefits and risks of the
advertised product. A separate comment expresses its support of these
views.
In response to those comments, another comment says that FDA should
not reconstruct the substantive contours of the major statement
requirement in the guise of defining neutrality, for example, by
requiring such concepts as comparative safety and effectiveness versus
other pharmacologic and non-pharmacologic approaches to treatment,
including lifestyle modifications.
(Response 5) We agree with the general principle that it is in the
interest of the public health that the risk information in an ad is
presented in an engaging manner and is neither overstated nor
understated. However, several of these comments focused in some way on
a perceived requirement that neutrality apply to DTC TV/radio ads
generally and were mistaken as to what information is required to be
included in the major statement or thought that FDA might change the
content of the major statement through this rulemaking. DTC TV/radio
ads, like all prescription drug ads, are required to contain a fair
balance of risk and benefit information (Sec. 202.1(e)(5)(ii)).
However, the requirement of a clear, conspicuous, and neutral manner of
presentation, as laid out in the statute, relates to the manner of
presentation of the major statement and not to the manner of
presentation of the ad as a whole. Further, FDA is not using this
rulemaking and the requirement of a
[[Page 80968]]
``clear, conspicuous, and neutral manner'' of presentation to change
the content of the major statement (e.g., the risk information
provided). Thus, this rulemaking, which addresses the manner of
presentation of the major statement, does not require that the major
statement include benefit information in comparison to risks,
quantitative information, or information about other pharmacologic or
non-pharmacologic approaches for the same indications.
FDA agrees that neutral means unbiased, and to provide more
specific direction to firms, we establish final standards that,
independently and collectively, help to ensure that the major statement
is presented in a neutral, as well as clear and conspicuous manner. We
acknowledge the research cited by the comment that describes how
patients' beliefs about prescription drugs relate to patient propensity
to adhere to certain prescription drugs. We agree that consumers'
beliefs and understanding about a prescription drug informs their
participation in important healthcare decision making, including
decisions about whether to take the prescription drug. This rule, by
establishing standards for the clear, conspicuous, and neutral
presentation of the major statement in DTC TV/radio ads, helps ensure
that consumers are better informed when they participate in healthcare
decision making and helps ensure that DTC TV/radio ads convey a
truthful, non-misleading net impression about the advertised drug.
(Comment 6) One comment makes two suggestions to overcome what it
described as biases held by manufacturers and consumers. First, it asks
that the rule require inclusion of the statement that ``The FDA has not
approved this ad'' to correct misleading beliefs that FDA approves all
ads and that only drugs that are proven to be very safe can be
advertised on TV. This comment argues that this required disclosure
would make the major statement more neutral by disassociating the ad
from any Government imprimatur regarding the safety of the drug or
whether such safety is adequately described by the ad the consumer is
seeing. Second, it asks that the rule require that the MedWatch hotline
statement be included in DTC TV/radio ads to communicate that, overall,
the drug being advertised is not known to be risk-free.
(Response 6) FDA has decided that we will not require through this
rulemaking the additional language requested by this comment addressing
FDA non-approval of the ad and the MedWatch hotline. As explained more
fully throughout this document, this rulemaking does not change the
content of the major statement, but rather establishes standards that
address the statutory requirement that the major statement be presented
in a clear, conspicuous, and neutral manner.
(Comment 7) Another comment states that the Distraction Study did
not provide helpful information for FDA to consider in determining
whether a major statement is presented in a neutral manner or provide
evidence that a neutral presentation of the major statement is
essential for the consumer to fully understand the risk and benefit
information.
(Response 7) The results of the Distraction Study are not the sole
justification for any part of this rule; rather, the results of that
study constitute one of many pieces of information FDA considered when
formulating the final standards for this rule. Furthermore, to the
extent the comment suggests that it may be unnecessary to present the
major statement in a ``neutral'' manner, we note that Congress has
established the requirement that the major statement be presented in a
``clear, conspicuous, and neutral'' manner, and this rule is being
issued consistent with that statutory requirement (21 U.S.C. 352(n)).
F. Consumer/Audience--Comments and FDA Response
The clear, conspicuous, and neutral statutory requirement applies
to ads for human prescription drugs that state the name of the drug and
its conditions of use that are presented directly to consumers in TV or
radio format (21 U.S.C. 352(n)). So, this final regulation applies to
such ads directed toward consumers. FDA proposed in standard #1 that to
be considered clear, conspicuous, and neutral, the major statement must
be ``presented in language that is readily understandable by
consumers.'' In the final rule, the language of ``by consumers'' is not
included within this standard, for reasons explained below.
(Comment 8) One comment suggests that FDA add the word
``reasonable'' before ``consumer'' in proposed standard #1 to be
consistent with FDA's draft Risk Guidance. A second comment suggests
adding more substance to the standard by requiring the firm to take
into account its audience either by adding ``reasonable consumer'' or
``consumer[s] to who[m] the ad is directed'' to the end of proposed
standard #1. Another comment, citing Sims v. GC Services, L.P., 445
F.3d 959, 963 (7th Cir. 2006), suggests that FDA use the standard that
the FTC adopted in relation to debt collection practices, i.e., a
``least sophisticated consumer'' standard--someone who is ``uninformed,
na[iuml]ve, or trusting'' but who has a ``rudimentary knowledge [about
the subject] and who is capable of making logical deduction[s] and
inferences.''
(Response 8) Because this regulation applies only to DTC TV/radio
ads, it is inherent that the audience for these ads is consumers, and
it is unnecessary to specify a consumer audience in the codified text
of individual standards. Accordingly, although the proposed regulatory
text for standard #1 included the words, ``by consumers'', we do not
include ``by consumers'' in the text of standard #1 as finalized. It is
FDA's position that the ``consumer'' audience for a DTC TV/radio ad is
an ordinary consumer and that the ordinary consumer acts reasonably--a
position that is consistent with the Agency's longstanding approach in
evaluating DTC prescription drug advertising, including the approach
reflected in the 2009 draft Risk Guidance (Ref. 26), an approach which
remains unchanged since the proposed rule. For the purposes of this
rulemaking, FDA declines to adopt the ``least sophisticated consumer''
standard used by FTC for debt collection practices, which primarily
focuses on specific content related to such practices. The ordinary
consumer better aligns with FDA's interests in addressing the
presentation of risk in DTC ads.
G. Proposed Standard #1 (Final Standard #1) (Language)--Comments and
FDA Response
FDA proposed in standard #1 (proposed Sec. 202.1(e)(1)(ii)(A))
that to be considered clear, conspicuous, and neutral, the major
statement must be ``presented in language that is readily
understandable by consumers.'' The concept of using language tailored
to the consumer audience is consistent with other approaches for
consumer disclosures (Refs. 40 and 26) (75 FR 15376 at 15378). We
retain this concept in the final rule but, as further explained in this
section, we modified this standard (final standard #1) to require that
the major statement ``is presented in consumer-friendly language and
terminology that is readily understandable.'' We have made these
changes in response to comments we received.
(Comment 9) Several comments suggest that the terminology of the
major statement, as well as the language used, should be readily
understandable by consumers. Some comments say that
[[Page 80969]]
the risk language in DTC ads is often cumbersome, confusing, and
difficult for most consumers to understand. One comment says that most
people will not really listen to this information, and a different
comment says that ambiguous terms are problematic. One comment also
notes that using scientific language in ads may mislead consumers by
creating a false impression that the drug has been more rigorously
tested and is thus safer than has actually been shown. Another comment
requests that the proposed standards mimic FTC phone ad requirements,
which require that the disclosure of risk information use the same
language (e.g., Spanish) as the presentation of benefit or other parts
of the ad.
(Response 9) We generally agree with these comments--both the
language and terminology used in the major statement should be readily
understandable by consumers. We note that there seemed to be some
confusion regarding the meaning of the word ``language'' in the
proposed rule. FDA did not intend to focus on foreign language
requirements through this rulemaking. To help clarify our intent, we
added ``consumer-friendly'' and ``terminology'' to this standard. These
revisions are intended to clarify that the major statement must use
consumer-friendly language and terminology that is readily
understandable, rather than medical or technical jargon or terms
usually more familiar to HCPs.
(Comment 10) One comment states that the neutrality requirement
should mean that the risks and benefits presented in DTC ads in TV/
radio format are presented at a uniform literacy level with minimum
technical jargon and that the information is relayed in a uniform
typeface and uniform speed of speaking to minimize the under-
comprehension of risks and the distortion of benefits.
Several comments request that FDA define specific criteria for
assessing whether the major statement is ``readily understandable by
consumers,'' such as in terms of a standard acceptable reading level.
The comments suggest a variety of standards: (1) the Flesch-Kincaid
Grade Level readability score; (2) the Agency for Healthcare Research
and Quality's Effective Health Care Program guides, which are written
at a sixth-grade literacy level; (3) the least informed person of
limited literacy likely to view and be influenced by an ad; or (4) a
general sixth-grade reading level.
(Response 10) FDA agrees that final standard #1 is part of the
evaluation of whether a major statement is presented in a neutral (as
well as clear and conspicuous) manner. As discussed above, the
regulation requires consumer-friendly language and terminology that is
readily understandable. However, FDA declines to limit this standard
through this rulemaking to language associated with a particular grade
level of reading or similar criterion as it may be necessary to include
certain terms (e.g., reference a disease like ``tuberculosis'') in the
major statement that could result in a relatively high grade level
rating. This final standard requires that the language used to provide
the major statement's risk information is understandable to the
ordinary consumer while providing manufacturers with flexibility in
designing their ads.
(Comment 11) Several comments seem to respond to our suggestion in
the proposed rule that vague terms subject to more than one
interpretation should be avoided (e.g., say ``more than half'' rather
than ``some patients'') (75 FR 15376 at 15379). One comment suggests
that safety information should be described in ways that are similar to
the full FDA-approved product labeling. Another comment expresses
concern about the potential for the example used in the proposed rule
to evolve toward a general requirement to use more quantitative
descriptors (e.g., frequency of risk, such as ``more than half'') and
the impact it might have on comprehension of risk information. Instead
of a general requirement to use more quantitative descriptors, the
comment requests a more case-specific approach applied on an ad-by-ad
basis that could be objectively tested with the target audience to
assess whether risk information is comprehended and understood.
Another comment recommends that FDA include clarification of
appropriate threshold levels for quantifying risks for bothersome,
significant, serious, or life-threatening risks attributable to the
drug. The comment suggests that these thresholds be based on research
in the field of risk communication to ensure that patients can
interpret risk at the optimal level. The comment also notes that
describing risks in quantitative terms may increase the conspicuousness
of the risk information by drawing a consumer's attention to the
reality of the risk described and may provide consumers with an
evidence-based presentation that is scientifically justifiable,
increasing the neutrality of the ad.
(Response 11) We did not intend to propose, and have not included
in the final rule, a general requirement that the major statement use
quantitative descriptors. As we stated in the preamble of the proposed
rule, ``The major statement should also avoid the use of vague terms or
explanations that are readily subject to different interpretations,''
such as ``some'' (emphasis in original) (75 FR 15376 at 15379).
Although this example involved quantitative terminology (``more than
half''), we did not intend to require that the major statement always
include quantitative descriptors but rather to clarify that to be
``readily understandable,'' the major statement must avoid language or
terminology that is so vague as to be readily subject to different
interpretations.
H. Proposed Standard #2 (Final Standard #2) (Audio)--Comments and FDA
Response
FDA proposed in Sec. 202.1(e)(1)(ii)(B) that audio information in
the major statement must be understandable in terms of the volume,
articulation, and pacing used. This standard remains important for
consumers to notice, attend to, and understand a drug's risk and
benefits. We modified this standard in the final rule to clarify that
the audio information presented during the major statement, in terms of
the volume, articulation, and pacing used, must be at least as
understandable as the audio information presented in the rest of the ad
(standard #2).
(Comment 12) We received several comments supporting this proposed
standard but also containing suggestions for improvement. One comment
notes that proposed standard #2 is especially important to older adults
or to consumers who, as a result of their literacy level or of visual
or other limitations, may rely more heavily on the audio portions of an
ad. Several comments note that the speed at which risk information in
the major statement is presented in broadcast ads often makes it
difficult to understand the information. One comment states that it is
unacceptable for risk information to be ``raced through as if being
uttered by an auctioneer'' and suggests that the pace of risk
information should be identical to the pace of benefit information.
Two comments express concern that the proposed standards would
increase the length of ads. One of these comments states that proposed
standards #2 (audio information) and #3 (textual information) could
impact the duration of an ad for a drug with substantial risk
information.
(Response 12) We agree with the comments stating that this standard
is especially important to consumers who may rely on the audio portion
of an ad to understand the major statement,
[[Page 80970]]
particularly older adults, as older adults watch more television (Ref.
41) and are more likely to take prescription drugs (Refs. 42 and 43).
As such, this standard in the final rule clarifies that the audio
information presented during the major statement, in terms of the
volume, articulation, and pacing used, must be at least as
understandable as the audio information presented in the rest of the
ad. The intention of this final standard is to ensure that the volume,
pacing, and articulation of risk information presented in audio allow
the information to be understood. Firms have an incentive to present
the benefits of a drug in audio using volume, articulation, and pacing
that ensure that those benefits are understood. Therefore, requiring
that, in terms of these same attributes, the audio presentation of the
major statement must be at least as understandable as the rest of the
ad, will help ensure that the risk information in the major statement
is similarly likely to be understood. This final standard provides a
concrete way for firms to help meet the requirement that the major
statement be presented in a clear, conspicuous, and neutral manner.
We disagree with the comments that assert that the rule will
necessarily lengthen DTC TV/radio ads. As discussed in section V.K of
this document (see comment 21), no comments, including those from
industry, provided specific data, information, or examples of how the
rule would require an increase in the length of these ads. FDA
concludes that the rule will not require DTC TV/radio ads to be longer.
(Comment 13) One comment notes that the focus on volume,
articulation, and pacing is important but overlooks the existing
regulatory framework for the disclosure of risk information in DTC ads
that results in a long disclosure of numerous risks, some of which are
more relevant to the physician and to the patient-physician interaction
once the decision has been made by the physician to prescribe a
prescription drug product. This comment requests that FDA consider how
much information is appropriate for the format.
(Response 13) The manner of presentation of the major statement is
the focus of this rule. Neither the proposed rule nor this final rule
changes the content of the major statement.
I. Proposed Standard #3 (Final Standard #4) (Presentation of Text)--
Comments and FDA Response
The third proposed standard for presenting the major statement in a
clear, conspicuous, and neutral manner includes requirements for
``[t]extual information [to] be placed appropriately and . . .
presented against a contrasting background for sufficient duration and
in a size and style of font that allows the information to be read
easily.'' (See proposed Sec. 202.1(e)(1)(ii)(C)). We revised proposed
standard #3 (named final standard #4 in this final rule, codified as
revised in Sec. 202.1(e)(1)(ii)(D)) in response to comments, to
clarify that the standard applies to the text portion of the major
statement in TV ads and not to textual information in the TV ad
generally. We have also removed the requirement for duration of display
of text from this standard and address that topic in final standard #3,
the dual modality standard. We also reorganized the remaining
information in this standard for clarity. Like the corresponding
standard of the proposed rule, final standard #4 is informed by
relevant social science research as well as by the common themes seen
in standards of other Federal agencies for ``clear and conspicuous''
disclosures (see Refs. 40, 44-50; 75 FR 15376 at 15377-15379).
(Comment 14) One comment is concerned that proposed standard #3
(final standard #4) could be interpreted to require that all major
statements in all DTC ads in TV format include textual information. The
comment recommends that FDA clarify the proposed standard for the
manner of presentation of text in the major statement by inserting ``if
included'' after ``[t]extual information.'' If information from the
major statement is presented visually in text, the comment also
questions how it should be presented with other information, such as
``Available by prescription'' or ``See our ad in. . . .''
(Response 14) Proposed standard #3 (final standard #4) addressed
how to present textual information as part of the major statement,
without requiring that any textual information be included. However, in
this final rule, we require a dual modality presentation of the major
statement for ads in TV format, through a separate standard. See
section V.K of this document and Sec. 202.1(e)(1)(ii)(C). We therefore
decline to add the suggested phrase, ``if included.'' We agree that
this final standard #4 does not alone create an obligation to present
the major statement using text, but we consider it applicable to any
text used to present the major statement. We also revised language to
clarify that this standard applies only to the text portion of the
major statement in TV ads and not to other text. (Regarding the
presentation of other information, see also section V.J of this
document discussing final standard #5 (proposed standard #4) and
addressing other audio or visual elements during the presentation of
the major statement.)
(Comment 15) One comment says that the standard should take into
account that many patients seeing broadcast ads, such as older adults
and those with diseases that affect vision, may need larger letters or
other accommodations. Two comments state that text placed in the lower
portion of the TV screen is so small and rapidly displayed as to make
information illegible. A few other comments request that FDA require
firms to present risks in large, clear text, while another comment
quantifies the preferred size of the text to be at least as large as 7
percent of the screen.
(Response 15) We agree that text used in presenting the major
statement, including the font used, should allow the information to be
read easily. We disagree that it is necessary to dictate a specific
font size or other similar criterion. After considering comments, we
conclude that this level of detail is unnecessary because there is more
than one way to present the textual information that will allow the
text to be read easily. Different presentational elements may interact
and must be considered together, with more than one combination
allowing for the textual information to be read easily. For example,
increasing the amount of contrast between the font and the background
may improve readability. And, even at a smaller size, some styles of
font are more easily read compared to others. Duration of text is
addressed in the final rule as an aspect of dual modality. (See
discussion in section V.K of this document.)
(Comment 16) One comment expresses concern that proposed standard
#3 is overly prescriptive and does not adequately take into account the
limitations of using text in audio-visual media such as TV. The comment
recommends that textual information be used as secondary support to
audio disclosure for the purpose of emphasizing particular risks when
necessary. The comment further recommends a more objective, data-
oriented approach to determine if information is understood and when
text information might be useful to emphasize a specific point, rather
than ensuring compliance with a specified text format.
(Response 16) We disagree with the portion of the comment stating
that proposed standard #3 is ``overly prescriptive.'' Like its
counterpart in the proposed rule, this standard in the final rule does
not dictate particular font
[[Page 80971]]
colors, sizes, placements, or backgrounds but instead requires that
these aspects of text together result in an easily readable
presentation. As suggested in comments, FDA intends these regulations
to be flexible enough to allow for a variety of techniques firms may
choose.
We disagree with the comment's suggestion that text should be used
to emphasize only particular risks rather than all risks contained in
the major statement. We note that the major statement, to which the
standards in this rule apply, is a selected presentation of the major
side effects and contraindications of the drug and not a listing of
every risk. In this final rule, we require a dual modality presentation
(audio and text) of the major statement for ads in TV format, for
reasons explained in section V.K of this document.
(Comment 17) One comment states that the proposed language about
textual information being placed appropriately and being presented
against a contrasting background is not consistent with the draft Risk
Guidance. The comment asserts that the draft guidance recommends that
risk information have a ``comparable background.'' The comment also
requests alignment with the draft Risk Guidance or clarification
regarding why there is a difference in opinion between the draft
guidance and the proposed rule for presenting risk information in TV/
radio ads versus through other media.
(Response 17) We conclude that the final rule's requirement (that
placement on the screen and contrast with the background, as well as
size and style of font, enable the text portion of the major statement
to be read easily) provides better assurance that the manner of the
presentation is clear, conspicuous, and neutral than the comment's
proposed requirement of a ``comparable background.'' Furthermore,
contrary to the comment, we believe these aspects of the standard are
consistent with the draft Risk Guidance, which was cited in the
proposed rule as describing factors and supportive research consistent
with the proposed rule's standards. Specifically, with respect to the
recommendations for non-print promotion such as TV ads and video, the
draft Risk Guidance discusses the comparable presentation of risk and
benefit information, not ``comparable background'' (Ref. 26, p. 15,
line 528). In fact, in its specific discussion of visual elements in
non-print promotions, the draft guidance also recommends that risk
disclosures presented in SUPERs contrast with background visuals (Ref.
26, p. 20, line 676).
With regard to the comment's question about distinctions in
presentation based on the medium used for the promotional
communication, we note that the draft Risk Guidance addresses
communications in the whole range of media; whereas, this rule is
specific to DTC TV/radio ads. Characteristics of effective
communication, including how consumers receive and understand
information, can be impacted by different factors for each type of
media, as reflected in the draft Risk Guidance recommendations and the
research that guidance cites, as well as in the final standards
established by this rule.
J. Proposed Standard #4 (Final Standard #5) (Elements That Interfere)--
Comments and FDA Response
FDA proposed in Sec. 202.1(e)(1)(ii)(D) that for a major statement
to be presented in a clear, conspicuous, and neutral manner, the major
statement must not include distracting representations (including
statements, text, images, or sounds or any combination thereof) that
detract from the communication of the major statement.
As described in section III.B of this document, in proposing this
standard, FDA noted that the presence of distracting elements during
the disclosure was one of several common themes addressed by standards
of other Federal agencies to ensure that disclosures were ``clear and
conspicuous'' (75 FR 15376 at 15378). FDA also noted that this standard
(and the other proposed standards) was consistent with the factors
described and discussed in the draft Risk Guidance (75 FR 15376 at
15379). The standard we finalize in this rule is generally consistent
with these approaches. We have modified this standard slightly from the
proposed rule as a result of the comments received (and to help ensure
effective communication).
In this final rule, we revised proposed standard #4, now final
standard #5 (codified as revised in Sec. 202.1(e)(1)(ii)(E)), to
clarify that the standard is intended to preclude the use of audio or
visual elements during the presentation of the major statement that are
likely to interfere with comprehension of the major statement, but the
standard does not address elements during other portions of the ad.
Audio or visual elements may include, for example, music or other
sounds, statements, text, and images. The standard does not
categorically prohibit particular types of elements during the major
statement but will be applied by considering the facts and
circumstances presented by specific ads.
(Comment 18) Several comments support limiting distractions during
the presentation of the major statement. One comment states that
presenting the major statement without distraction is the key to
improving audience understanding. Another comment says that distracting
images or sounds can seriously undermine the clarity and
conspicuousness of the presentation of risk information. One comment
goes further and states that the major statement cannot be allowed to
compete with distracting text, images, or sounds because it disrupts
comprehension.\6\
---------------------------------------------------------------------------
\6\ The comment provided reference to Sorqvist, P., et al.,
``Individual Differences in Susceptibility to the Effects of Speech
on Reading Comprehension,'' Applied Cognitive Psychology 24: 67-76,
2010, which concluded that irrelevant speech presented in audio
disrupted reading comprehension.
---------------------------------------------------------------------------
Several comments say that implementing proposed standard #4 is
particularly important because the visual depiction of benefits
distracts from any simultaneous verbal presentation of risks,
especially when the risk information is listed in a monotone or
reassuring tone of voice. One comment argues that allowing positive
scenes to be shown while presenting risk information has an adverse
effect on a consumer's perception of the drug's risks. The comment
suggests that FDA require a more restrictive standard limiting drug
manufacturers from inserting the ads in an overly positive environment
or cheery setting and instead require that the text be displayed
simultaneously with visual scenes that reinforce the risk.
Other comments express reservations about proposed standard #4. One
comment states that proposed standard #4 could be misinterpreted to
suggest that all representations are ``distracting'' and detract from
communication of the major statement. The comment suggests that FDA
revise this standard to clarify that it does not intend to prohibit all
``representations,'' including text, images, or sounds, during
communication of the major statement. The comment suggests adding
``certain'' before ``statements'' and adding ``significantly'' before
``detract.''
One comment states that it does not generally oppose the proposed
standard but seeks clarification. In general, the comment interprets
the proposed standard as intending to require ``neutral'' imagery. The
comment opines that the concept of image neutrality is vaguely defined
and subjective,
[[Page 80972]]
requiring further definition in a final standard to avoid the risk it
could be interpreted in an unnecessarily restrictive manner that would
make DTC advertising impractical for pharmaceutical firms. More
specifically, the comment understands the proposed standard to be
intended to limit visuals that may be distracting during the major
statement and interprets this to include specifically the types of
positive images tested in the Distraction Study; however, it concludes
that the study did not support the position that such images would
impede the understanding of the safety information presented during the
major statement. The comment also says that a restriction on positive
imagery during the major statement could lead to a sterile ``public
service'' style presentation of the messaging and limit its efficacy.
The comment says that patient retention of messaging and motivation to
learn more could be decreased because, the comment asserts, such
messages would be less engaging and be ignored. The comment also says
it is unclear to what degree ``positive'' imagery before and after the
major statement would be allowable.
Another comment similarly expresses concern that proposed standard
#4 could require firms to begin presenting risk information in a very
bland manner that would be inconsistent with the overall flow and tone
of an ad, such that viewers may become disengaged with the ad when risk
information is being communicated. The comment encourages FDA to study
the impact of removing creative elements employed during communication
of risk information and how it affects comprehension. This comment
opposes including proposed standard #4 because, the comment opines, it
is too subjective and likely inadequate as a surrogate for whether the
target audience understands the risks communicated. The comment
expresses concern that FDA would apply an overly prescriptive approach
to evaluating proposed standard #4 and suggests instead an objective,
science-based approach to evaluating audience understanding and
comprehension of risk information.
(Response 18) We agree with comments that support the proposal to
limit distractions during presentation of the major statement. Final
standard #5 requires that during the presentation of the major
statement, the ad does not include audio or visual elements (music,
sounds, text, images, etc.) that, alone or in combination, are likely
to interfere with comprehension of the major statement of risk
information.
Several of the comments suggest a desire for clarification of the
focus or scope of proposed standard #4 (final standard #5). Some are
concerned that this standard precludes any elements during the
presentation of the major statement at all, while others appear to
equate this standard narrowly with the specific topics of study in the
Distraction Study or the concept of ``neutral'' alone--none of which
aligns with FDA's intention. In response, in the final rule, we revised
the wording to emphasize that in order to be presented in a clear,
conspicuous, and neutral manner, during the presentation of the major
statement, the ad must not include audio or visual elements that, alone
or in combination, are likely to interfere with comprehension of the
major statement. We conclude that the revised wording of this provision
better captures the standard for determining whether an element or a
combination of elements distracts from the mandatory presentation of
the major statement. The changes to the wording of final standard #5
also clarify that this requirement applies during the limited part of
the ad that presents the major statement, not to other portions of the
ad. This standard independently contributes to achieving a clear,
conspicuous, and neutral manner of presentation of the major statement,
adding to the effect of other standards in this rule.
We do not conclude that all audio or visual elements are likely to
interfere with comprehension of the major statement. In fact, as
addressed in section V.K of this document, in the final rule, by
requiring dual modality--the concurrent use of both text (a visual
element) and audio to present the major statement in ads in TV format--
we acknowledge that multiple elements can actually be used to reinforce
risk information.
This standard does not categorically prohibit use of other creative
elements during the major statement, nor does it prohibit narrower
categories of such elements (e.g., it does not bar music, sound
effects, or drawings). The standard does not even categorically
prohibit any subtypes of elements (e.g., it does not bar upbeat music
or amusing drawings). Notably, the standard does not categorically
prohibit visual depictions of benefits or positive imagery during
presentation of the major statement in TV ads.
It is not our intent that the major statement be presented in a
bland manner such that the audience becomes disengaged during this part
of the ad, nor do we intend to require a ``tombstone'' presentation of
the major statement. Rather, final standard #5 is a common-sense
measure that adds to the others to help ensure that consumers notice,
attend to, and understand the major statement by prohibiting the
simultaneous presentation of other audio or visual elements, alone or
in combination, that are likely to interfere with comprehension of the
major statement. This requirement applies only during the limited
portion of the ad that presents the major statement and places no
restrictions on any other part of the ad.
(Comment 19) Several comments discuss what effect the results of
the Distraction Study should have on FDA policy regarding proposed
standard #4 (final standard #5). One comment argues that design flaws
resulted in the failure of the Distraction Study to detect any
significant effects upon risk comprehension resulting from various
forms of distraction; therefore, the results must be disregarded.
Another comment states that the Distraction Study did not appear to
provide an adequate factual or rational basis upon which FDA can rely
to augment FDA's authority with respect to final standard #5 and the
entire rule. One comment states that certain design characteristics of
and results from the Distraction Study raise significant questions
about its utility to support regulatory decision making. Another
comment states that after reviewing the results of the Distraction
Study, any additional restrictions imposed on the clear, conspicuous,
and neutral standard would only ``muddy the waters'' and that a broad
requirement, with as little nuance as possible, would enable the Agency
to determine, unhindered, that a particular ad committed a violation of
the clear, conspicuous, and neutral requirement. One comment says that
in light of the results of the Distraction Study, it seems that the
only way to present the risk information is to require a standard
format for conveying risks. Experts could then continuously evaluate
the standard format and determine whether it was the most effective
method to convey the risk information.
(Response 19) Final standard #5 rests on a well-established
principle that presenting more than one element during the same period
of time, in some cases, interferes with comprehension of information.
This is often referred to as ``distraction.'' As manifested in numerous
other Federal disclosure standards (see 75 FR 15376 at 15377), in order
to support the effective presentation of required disclosures, it is
important to avoid distractions.
Addressing this concern is especially important in the ads in TV/
radio format
[[Page 80973]]
that are subject to this rule because these ads are fleeting--appearing
for a brief interval in the midst of other content--and within each
ad's overall running time, consumers typically do not control how much
time they have to absorb the information from the major statement. For
example, the average length of ads in TV format is between 30 and 60
seconds overall.\7\ In prescription drug ads, the presentation of the
major statement occupies only a part of the ad, so in a 30- or 60-
second ad, consumers are not given much time to notice and understand
that important information. If, during the presentation of the major
statement, the consumer's attention is instead focused on other
elements of the ad, the major statement may be relayed without being
understood.
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\7\ A 5-year study by DRMetrix included data from 2015 to 2018
and captured a total of 50 million DTC TV ad presentations. The
study evaluated the frequency with which different lengths of TV ads
were run. Ads of 30 seconds in length were run the most. See ``5 x 5
Industry Study,'' DRMetrix, 2019, available at <a href="https://www.drmetrix.com/public/5_x_5_Industry_Study_Oct_2019.pdf">https://www.drmetrix.com/public/5_x_5_Industry_Study_Oct_2019.pdf</a>.
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The possibility of distraction interfering with comprehension is
apparent from ordinary experience, and it is also amply supported by
social science research. For example, visual and auditory elements that
have been shown to detract from or interfere with the communication of
information and viewer comprehension include noise, loud music, and
rapid scene changes (Refs. 34, 35, 38, 39, 51-53). The reasonable
approach embodied by final standard #5 is to assess, case-by-case, the
particulars of a specific ad to determine whether, during the
presentation of the major statement, it includes audio or visual
elements that, alone or in combination, are likely to interfere with
comprehension of the major statement.
We rely on the existing substantial body of literature regarding
distraction as the basis for final standard #5, not FDA's Distraction
Study, contrary to the implication of some comments. As previously
addressed (see section V.C of this document), FDA's Distraction Study
was not an investigation of all elements or factors that can contribute
to distraction. The Distraction Study was designed only to examine the
effects of three particular, pre-defined factors: (1) the presence or
absence of SUPERs that concurrently presented verbatim, key words and
phrases from the audio presentation of risk; (2) variations in the
positive (affective) tone of visual images; and (3) visual information
that was either inconsistent or consistent with the audio risk
information. With regard to factor 2, this research investigated a
hypothesis that the visual depiction of positively toned imagery during
the simultaneous audio presentation of risk information would interfere
with comprehension of the risk information. Although study participants
in the strongly positive tone conditions showed lower risk
comprehension than participants in the mildly positive tone conditions,
this difference was not statistically significant. As a result, the
Distraction Study did not find support for the hypothesis that the
visual depiction of positively toned imagery interferes with the
comprehension of risk information in the major statement. Therefore,
conclusions about the effect of positively toned imagery on risk
comprehension cannot be drawn from this study.
Nonetheless, FDA's Distraction Study did not call into question the
substantial body of literature on different and more obvious types of
distractions (e.g., noise, loud music, rapid scene changes); this study
did not include and was not designed to test these well-known types of
interferences. Thus, we rely on the existing substantial body of
literature on this topic to support standard #5 in the final rule.
We also disagree with the comment that suggests FDA might use the
Distraction Study to ``augment'' its authority. Congress passed a law
requiring that the major statement relating to side effects and
contraindications in DTC TV/radio ads be presented in a ``clear,
conspicuous, and neutral'' manner, and Congress directed FDA to issue
standards for determining whether a major statement is presented in
this manner. Final standard #5 (as well as the other final standards in
this regulation) is consistent with this grant of statutory authority.
K. Dual Modality (Final Standard #3)--Comments and FDA Response
In the proposed rule, FDA solicited public comment on whether to
require that the major statement in ads in TV format be included in
both the audio and visual parts of the presentation (dual modality) (75
FR 15376 at 15380). We referenced the FTC standard for determining
whether an affirmative disclosure in a television commercial is clear
and conspicuous, which states that for disclosures in a television
advertisement to be clear and conspicuous, they should be presented
simultaneously in both the audio and video (75 FR 15376 at 15377,
15380). In addition, we referenced research specifically conducted on
the subject of dual modality in advertising that supported the use of
simultaneous presentations of key words or full sentences in text with
the corresponding key words or full sentences in audio to aid in
processing (75 FR 15376 at 15383), as well as a broader body of
research that supports the use of dual modality in a wide variety of
situations (75 FR 15376 at 15383-15384).\8\ We also reopened the docket
in 2012 to include the report of the Distraction Study that
investigated dual modality presentation of the major statement in TV
ads (among other things) and we requested comments on the results of
that study as those results related to the proposed standards. As
summarized in the document reopening the comment period--and further
detailed in the study report in the docket--the study indicated that
presenting the same risk information at the same time in text and in
audio improves consumer understanding of the risk information (see 77
FR 4273-74; Ref. 27). Thus, the results of FDA's Distraction Study
regarding the effects of dual modality on comprehension of risk
information were in line with the studies described in the 2010
proposed rule. Not only did the Distraction Study find that presenting
the same risk information at the same time in text and in audio
improved risk comprehension, but it also found that presenting risk
information in dual modality was not associated with any reduction in
comprehension of benefits (Ref. 27). Subsequent research (Refs. 53-56)
corroborates the evidence--originally discussed in the proposed rule
and again in the Distraction Study report that was made available for
public comment--that presenting information in both audio and visual
(dual modality) improves comprehension of the information provided. The
comments we received helped inform our decision to require dual
modality in this final rule, supported by the Distraction Study
research and subsequent research and literature.
---------------------------------------------------------------------------
\8\ For additional corroboration, also see Murray, N.M., L.A.
Manrai, and A.K. Manrai, ``Public Policy Relating to Consumer
Comprehension of Television Commercials: A Review and Some Empirical
Results,'' Journal of Consumer Policy, 16(2):145-170, 1993; Tindall-
Ford, S., P. Chandler, and J. Sweller, ``When Two Sensory Modes Are
Better Than One,'' Journal of Experimental Psychology: Applied,
(3):257-287, 1997.
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The majority of comments on this topic support dual modality, while
a few comments opposed it.
(Comment 20) Overall, the comments addressing dual modality favor
the implementation of this standard. Comments note that dual modality
will
[[Page 80974]]
help improve consumer understanding of the risk information and help
make a lasting impression on consumers. Comments also noted that dual
modality would account for consumers with different learning styles and
pointed out that research supports dual modality. Additionally,
comments noted that FTC has a similar standard and that including the
dual modality standard would provide firms with direction on how to
properly adhere to the ``clear, conspicuous, and neutral''
requirements. One comment gives certain critiques of the Distraction
Study's methodology but ultimately supports a dual modality
requirement.
Comments that oppose dual modality assert that it is unnecessary
and could distract consumers or have potentially negative consequences.
One of these comments states that presenting complex clinical risk
information simultaneously in both the audio and text could prevent
consumers from effectively receiving this crucial information from
either mode of communication. This comment says that viewers who focus
on the audio component might assume that the text qualifies the audio
message, leaving them to question the veracity of whatever portion of
the major statement they processed and understood.
One comment says that even though the Distraction Study suggests
that in some contexts it may be possible to improve comprehension of
benefit and risk information through a dual modality requirement, there
are significant questions regarding the interpretability of that data.
Consequently, the comment claims that the Distraction Study was not
robust enough to support imposing a dual modality requirement in FDA's
regulation. The comment argues that although the difference in risk
comprehension between the no SUPERs cohort and the combined large and
small SUPERs cohorts in the Distraction Study appears to be
statistically significant, there is no indication that it is
significant from a clinical or regulatory point of view. The comment
states that even if FDA's study showed that consumers had better risk
comprehension when SUPERs were used, it does not follow that ads that
do not use SUPERs are: (1) false, misleading, or otherwise lacking in
fair balance or (2) not clear, conspicuous, or neutral. The comment
argues that ads both with and without SUPERs could be legally
acceptable. Therefore, according to the comment, the Distraction Study
may provide useful information regarding optimal advertising practices,
but it does not provide information that is relevant from a regulatory
perspective.
The comment also states that the Distraction Study does not
foreclose the possibility that other advertising techniques, either
alone or in combination, may be as effective or even more effective
than a dual modality requirement in optimizing comprehension of risks
and benefits and rendering the major statement ``clear, conspicuous,
and neutral.'' The comment states that advertisers should have
regulatory flexibility in designing DTC TV ads in a manner that
complies with applicable requirements to communicate risks, without FDA
imposing a dual modality requirement.
One comment opposes dual modality, arguing that it does not improve
consumer recall or understanding of important risk information in DTC
ads. The comment describes research that the submitting firm undertook
in 2005, the results of which suggest that recall of risk and benefit
information does not vary in consistent or systematic ways according to
ad risk presentation or execution, including when dual modality is used
to present major risk terms. The comment also states that the
limitations of this study may have affected observed results. The same
firm subsequently submitted the results of additional research it
undertook several years later, described further in the response to
this comment, which do support a dual modality requirement.
(Response 20) We have included a dual modality requirement in this
final rule (Sec. 202.1(e)(1)(ii)(C)) after consideration of comments
we received, as well as research and literature supporting the positive
impacts of dual modality on risk comprehension and recall that existed
at the time of the proposed rule. Notably, as detailed further in
section V.K of this document, subsequent research corroborates these
earlier findings on the positive impact of dual modality on recall and
comprehension of risk. Under this standard, for the major statement of
an ad presented in TV format to be presented in a clear, conspicuous,
and neutral manner, it must be presented concurrently using both audio
and text (dual modality). To achieve dual modality, the regulation
establishes further specific standards for the display of text. First,
either the text displays the verbatim key terms or phrases from the
corresponding audio, or the text displays the verbatim complete
transcript of the corresponding audio. Second, the text must be
displayed for a sufficient duration to allow it to be read easily.
Under the final regulation, for purposes of this standard, duration of
the text display is sufficient if it begins at the same time and ends
at approximately the same time as the corresponding audio. These
duration and display characteristics are supported by the research
studies that evaluated concurrent text and audio presentations (dual
modality), discussed in the proposed rule and in section V.C of this
document. Moreover, as discussed in section V.K of this document, other
research subsequently corroborated these research findings regarding
the positive impact of dual modality on consumer recall and
comprehension.
We do not agree with the comment suggesting that dual modality
could prevent consumers from effectively receiving risk information. No
references were provided to support this assertion. To the contrary, as
discussed in the preamble of the proposed rule (75 FR 15376 at 15383-
15384), research shows that using audio and visual presentations to
present the same information at the same time increases comprehension
compared to using only one mode (See also Refs. 57 and 58). Research
demonstrates improved recall when reinforcing SUPERs are used, and
suggests that a dual mode of presenting information results in greater
recall and comprehension in a wide variety of situations (Refs. 53, 59,
and 60-64). The positive impact of dual modality on recall and
comprehension has been further demonstrated through subsequent research
(Refs. 54-56).
FDA's Distraction Study examined, in part, how an ad's SUPERs might
influence understanding of the risk information in the audio portion of
the ad. As summarized in the Federal Register document reopening the
docket to solicit comments on the results of this study as related to
the proposed standards (77 FR 4273-74) and further detailed in the
study report in the docket (Ref. 27), we found that presenting the same
risk information at the same time in text and in audio improves
consumers' understanding of that risk information compared to audio
alone. This finding is statistically significant and consistent with
prior research. The Distraction Study also found that there was no
tradeoff to the presentation of risk using dual modality in regard to
comprehension of benefit; the increase in risk comprehension was not
associated with any reduction in benefit comprehension (Ref. 27).
As noted previously, research results submitted by a firm had
similar findings about use of dual modality. The firm undertook
research to determine how dual modality might affect consumers' recall
and comprehension of
[[Page 80975]]
information in the major statement of prescription drug TV ads. The
firm's research results demonstrated that dual modality increased risk
recall and understanding of risks. The results also demonstrated that
dual modality did not decrease consumer recall and understanding of
product benefits. Whether the full text of the risk statement or
keywords were presented visually did not affect recall and
comprehension of risk information. This submitted research corroborates
other research in the record.
(Comment 21) One comment asserts that the proposed rule was unclear
regarding ``what specific information from the major statement should
be presented visually or how that visual information should be
presented with other information, such as `Available by prescription'
or `See our ad in Health magazine.' '' The same comment questions
whether FDA would require ``a simultaneous, verbatim presentation'' of
the major statement in the audio and video or only require the firm to
use each mode to present the major statement at some point in the ad.
It further asserts that regardless of whether dual modality requires
simultaneous presentation of the major statement in both audio and
text, a visual presentation of the major statement would need to appear
on screen for a significant portion of many ads to allow consumers of
all abilities sufficient time to read and absorb the risk information,
which in turn might overemphasize risk information and thus result in
the non-neutral presentation of that risk information. That comment
also suggests that to meet a dual modality requirement, TV ads would
necessarily grow in length to accommodate required additional text.
However, another comment says that fulfilling a dual modality
requirement would not require more ad time, and in fact, requiring
audio and visual presentation of the major statement to occur at the
same time might even reduce ad length. A third comment expresses the
view that, to improve consumer risk awareness, the regulation should
require that the major statement be presented in dual modality, using
text that is either identical to the audio track or an abbreviated,
easily processed bullet point type of text, using only words that occur
in the audio track.
(Response 21) To reinforce the presented risk information and
consequently help improve its comprehension, the final rule requires
the concurrent presentation of the major statement in the audio and in
text. This is consistent with the proposed rule, which reflected the
expectation that where text was used, it would appear ``concurrently
with any directly related audio information'' (75 FR 15376 at 15379) as
well as with the research cited in the proposed rule (75 FR 15376 at
15383). This is also consistent with the FTC standard, cited in the
proposed rule, for determining whether an affirmative disclosure in a
television commercial is clear and conspicuous, which states that for
disclosures in a television advertisement to be clear and conspicuous,
they should be presented simultaneously in both the audio and video
(Ref. 65) (75 FR 15376 at 15377 and 15380). Further, the final rule
provides additional clarity on how to achieve a dual modality
presentation of the major statement regarding what text must appear,
when the text must appear in relation to the audio, and for what
duration--consistent with research cited in the proposed rule (75 FR
15376 at 15383) and the approach used in the Distraction Study, the
report of which was placed in the docket and the comment period
reopened expressly to solicit comment on the results of that study in
relation to the proposed standards (77 FR 4273-74; Ref. 27). The
provisions in the final rule collectively provide considerable
flexibility to firms and do not necessitate that the textual
presentation of the major statement remain on screen throughout the ad.
We agree with the comment noting that the text used to achieve dual
modality should present words that the corresponding audio uses, rather
than synonyms, and also agree that dual modality can be achieved using
text in an abbreviated form. This is consistent with the approaches
used in research that was cited in the proposed rule and that supported
dual modality (75 FR 15376 at 15383), as well as the approach used in
the Distraction Study (Ref. 27). Accordingly, the final rule specifies
that dual modality can be achieved either by displaying the verbatim
key words or phrases from the corresponding audio or by displaying the
verbatim complete transcript of the corresponding audio. This provides
firms flexibility to choose from various presentation options. For
example, if the audio states, ``The most common side effects of DRUGX
are dry mouth, headache, and heartburn,'' instead of presenting a
complete verbatim transcript of that statement, the accompanying text
could present bullets stating ``<bullet> dry mouth <bullet> headache
<bullet> heartburn.''
The final rule also addresses the duration of text display. Like
proposed standard #3 (which alone would not have required text, but
addressed how to present text if it were used in addition to the
already-required audio to present the major statement), the final rule
requires that text used to present the major statement be displayed for
a duration that allows it to be read easily. Discussion of proposed
standard #3 also indicated our intention to require that visually-
presented text information from the major statement appear
``concurrently with any directly related audio information'' (75 FR
15376 at 15379). These elements of proposed standard #3 regarding the
display of text are now picked up as part of the dual modality
requirement (final standard #3). Final standard #3 clarifies their
relationship to each other and to the audio presentation requirements
of the rule, stating that the duration of display of text is sufficient
if it starts at the same time and ends at approximately the same time
as the corresponding audio. This approach is similar to that required
for the presentation of closed captioning under Federal Communication
Commission regulations. See 47 CFR 79.1(j)(2)(ii). In turn, the pace of
the audio component of the major statement is determined by the
requirement that the audio information be at least as understandable as
the audio information presented in the rest of the ad--something that
the firm chooses. (See final standard #2 (Sec. 202.1(e)(1)(ii)(B)) and
section V.H of this document.) With this flexibility, we believe the
presentation of risk information will not be overemphasized. None of
the standards of the final rule that impact duration of text display,
including the dual modality standard, either separately or together,
require that the textual presentation of the major statement remain on
screen throughout the ad or generally require increasing the length of
ads in order to present the major statement. At the same time, we think
the methods of achieving dual modality described by the rule will
contribute to presenting the major statement in a clear, conspicuous,
and neutral manner.
L. First Amendment Freedom of Speech--Comments and FDA Response
Two comments question whether the proposed rule is consistent with
First Amendment protections for freedom of speech. One addresses the
major statement's requirement to disclose side effects generally; the
other focuses on the proposal for presenting the major statement using
dual modality.
(Comment 22) One comment asserts that the overall requirement for
the major statement to disclose side effects is unconstitutional under
the Supreme Court's decision in Central Hudson Gas & Elec. Corp. v.
Pub. Serv. Comm'n, 447 U.S. 557 (1980), regarding commercial
[[Page 80976]]
speech restrictions, but the comment does not address any specific
elements of the proposed manner of presentation that are the subject of
this rulemaking. This comment asserts that, for the Government to
restrict advertising, among other things, the advertising must be
misleading, and the comment states without elaboration that ``lack of
disclosure or lack of clarity'' of side effects does not make
advertising misleading. The comment also asserts that the Government
has no substantial interest in mandating disclosure of risk information
in DTC ads in TV/radio format and, consequently, that no requirements
for a major statement in a DTC ad could satisfy the First Amendment.
The comment states that the Government interest implicated by requiring
disclosure of side effects in DTC prescription drug advertising is one
intended to protect consumer safety but that this interest ``cannot be
proven as substantial'' because it is already addressed by the
requirement to obtain a prescription to access a prescription drug. The
comment further suggests that the information is unnecessary in ads
because all prescription orders explain drug side effects.
Another comment raises concerns that a dual modality requirement
would violate the First Amendment. The comment suggests that the
proposed dual modality requirement is subject to First Amendment
analysis under Central Hudson and under Thompson v. Western States
Medical Center, 535 U.S. 357 (2002), and also suggests that ``a
regulatory scheme that formats the style and content of advertising in
advance of its presentation to the public'' might impose an unlawful
prior restraint on advertising. In addition, the comment asserts that
to hold a firm liable for failing to use dual modality, FDA would have
to prove that absent dual modality, the ad would be false or misleading
to the consumer, noting that a consumer cannot obtain a prescription
for an advertised drug without consulting a physician. The comment
suggests that, unless FDA can establish in advance that all ads that
lack dual modality would be false or misleading, the dual modality
requirement is not constitutional.
(Response 22) We disagree that the major statement requirement as a
whole, the dual modality requirement in particular, or any other aspect
of this rule's standards for presenting the major statement in a clear,
conspicuous, and neutral manner violates the First Amendment.
As the Supreme Court has explained, Government mandates for
``health and safety warnings'' have been ``long considered
permissible,'' and these warnings as well as ``purely factual and
uncontroversial disclosures about commercial products'' are legal under
the First Amendment (Nat'l Inst. of Family and Life Advocates v.
Becerra, 138 S. Ct. 2361, 2376 (2018)). The presentation of the major
statement addressed in this rule, as well as the underlying requirement
to provide the important side effects and contraindications of the
drug, fall squarely within these categories.
Specifically, the major statement is quintessential health and
safety warning information, reflecting the contraindications and side
effects of a prescription drug as described in the prescription drug's
approved labeling. The content of the major statement is not changed by
this rulemaking. As explained in section III of this document, there is
a long history of requirements to provide health and safety warnings
about a prescription drug's risks, including in its advertising, and to
ensure that understanding of required disclosures about these products
is not undermined by an inadequate manner of presentation of the
information.
More generally, the major statement is a factual disclosure about a
commercial product to be included in its advertising. The Supreme Court
examines factual disclosures about products and services in commercial
speech under the analysis in Zauderer v. Office of Disciplinary
Counsel, 471 U.S. 626 (1985). See Nat'l Inst. of Family and Life
Advocates, 138 S. Ct. 2361, 2377-2378; Milavetz, Gallop & Milavetz,
P.A. v. United States 559 U.S. 229, 250, 252-253 (2010). Under the
approach articulated in Zauderer, courts have upheld required
disclosures of factual and uncontroversial information about a product
or service in commercial speech about that product or service. See,
e.g., American Hosp. Ass'n, 983 F.3d 528, 540 (posting negotiated rates
for hospital services); American Meat Inst. v. Dept. of Agric., 760
F.3d 18 (D.C. Cir. 2014) (en banc) (country of origin labeling for
meat); N.Y. State Restaurant Ass'n v. N.Y.C. City Bd. of Health, 556
F.3d 114 (2d Cir. 2009) (calorie information on menus); Nat'l Elec.
Mfrs. Ass'n, 272 F.3d 104 (labeling identifying presence of mercury in
light bulbs). Where such disclosures are not unjustified or unduly
burdensome, their imposition does not offend the First Amendment. See,
e.g., Nat'l Inst. of Family and Life Advocates, 138 S. Ct. 2361, 2377-
2378; American Hosp. Ass'n, 983 F.3d 528, 541 (required publication of
standard charges is not unduly burdensome in a way that chills
commercial speech as it ``neither requires hospitals to endorse a
particular viewpoint nor prevents them from adding their own message on
the same website or even in the same file''; alleged financial burden
of compliance with the disclosure requirement not established to be
burden on speech); Spirit Airlines, Inc. v. United States Dep't of
Transp., 687 F.3d 403, 414 (D.C. Cir. 2012) (requirement for airlines
to make total price the most prominent cost figure does not
significantly burden airlines' ability to advertise); Discount Tobacco
City & Lottery, Inc., 674 F.3d 509, 524 (size of required tobacco
warnings is not unduly burdensome where remaining portions of their
packaging are available for other information).
The provisions of this rule likewise satisfy the requirements of
Zauderer and subsequent cases. First, the required information about
the drug's side effects and contraindications presented in the major
statement is factual and uncontroversial. As already noted, it is
derived from the drug's FDA-approved labeling, which is based on data
and information about the product submitted by the drug's sponsor and
evaluated by FDA.
Second, requiring that this information be presented in DTC TV/
radio ads in a clear, conspicuous, and neutral manner is justified by
the interests described in section III of this document. Contrary to
the implications of both comments, the substantial Government interests
supporting these measures are not limited to preventing consumers from
being misled or protecting consumer safety. Rather, the substantial
Government interests underlying this rule also include helping to
ensure consumers are better informed when they participate in
healthcare decision making, including when no HCP is present (see
discussion in section III.A). Communicating risk information in a
manner that improves the likelihood that consumers notice, attend to,
and comprehend that information is instrumental to advancing this
purpose of including risk information in the first place. See Discount
Tobacco City & Lottery, Inc., 674 F.3d 509, 561-564 (enhanced warnings
on tobacco products advance the interests in promoting greater public
understanding of the risks of those products; ``A warning that is not
noticed, read, or understood by consumers does not serve its
function'').
Third, this rule is not unduly burdensome. The final rule's
requirements for the manner of presenting the major statement--
including the requirement for dual
[[Page 80977]]
modality--do not threaten to drown out or chill the firm's other
messages. Indeed, the firm not only remains free to present other
messages in the ad; under this rule, it retains substantial ability to
choose how to present the major statement.
For example, the major statement has long been required to be
presented in audio. This rule provides more direction on how to do so
but leaves many implementation details up to the firm. With regard to
this audio presentation, the final standard requires that the volume,
articulation, and pacing make the audio presentation of the major
statement ``at least as understandable as the audio presented in the
rest of the advertisement'' (Sec. 202.1(e)(1)(ii)(B))--leaving it
substantially up to the firm how it wants to use audio for all the
content in the ad. To fulfill the dual modality requirement for ads in
TV format, the display of text is sufficient if it begins at the same
time and ends at approximately the same time as the corresponding audio
and displays the verbatim key terms or phrases from the corresponding
audio (Sec. 202.1(e)(1)(ii)(C)). Ultimately, then, this final rule,
including dual modality, retains the firm's substantial control of the
overall presentation and duration of the major statement and preserves
the firm's opportunity to present the advertised drug's benefits or any
other messages in other parts of the ad. And, as discussed in section
V.K of this document, the use of dual modality does not decrease the
recall or comprehension of benefit information even while it improves
consumer comprehension and recall of the risk information, advancing
the Government interests discussed in section III.A.1 of this document.
While we conclude that Zauderer provides the relevant framework for
analysis of the mandatory risk disclosure provisions of this rule and
that its requirements are satisfied, we also conclude that this
rulemaking is consistent with the First Amendment if analyzed under
more exacting scrutiny, including Central Hudson, a case mentioned by
both comments. Contrary to the implication of both comments, FDA's
authority to regulate prescription drug advertising is not limited to
cases in which that speech is misleading (or false). Rather, under the
Central Hudson framework, even if commercial speech is truthful, is not
inherently or actually misleading, and relates to lawful activity, the
Government may impose restrictions that directly advance a
``substantial'' Government interest and are no ``more extensive than is
necessary to serve that interest'' (Central Hudson Gas & Elec. Corp.,
447 U.S. 557, 566).
In cases examining limitations on commercial speech, the Supreme
Court has endorsed ``the principle that disclosure of truthful,
relevant information is more likely to make a positive contribution to
decisionmaking than is concealment of such information'' (Peel v.
Attorney Registration and Disciplinary Comm'n of Illinois, 496 U.S. 91,
108 (1990)). As a result, the Court has favored use of disclosures over
restrictions on speech to advance the substantial interests in
preventing consumers from being misled and in making a positive
contribution to informed decision making (id. at 109-110); Shapero v.
Kentucky Bar Ass'n, 486 U.S. 466, 477-478 (1988); In re R.M.J., 455
U.S. 191, 203 (1982); Bates v. State Bar of Arizona, 433 U.S. 350, 375
(1977); Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer
Council, 425 U.S. 748, 770 (1976).
Similarly, the FD&C Act and FDA implementing regulations require
disclosures of risk information where prescription drug ads promote the
product's benefits to directly advance the substantial Government
interests previously described in section III of this document. The
requirements in this rule to ensure that important facts about the
risks of an advertised drug are presented in a clear, conspicuous, and
neutral manner in its DTC TV/radio ads are reasonable in proportion to
these interests and thus present no constitutional infirmity under any
potentially applicable First Amendment standard.
Three of the standards for presenting the major statement address
basic techniques for any communication targeting a broad consumer
audience: that it uses consumer-friendly language and terminology,
rather than technical language; that its audio be at least as
understandable as other audio in the same ad; and that the visual
aspects of text used to present the major statement allow that text to
be read easily. (See Sec. 202.1(e)(1)(ii)(A), (B), and (D).) The two
remaining standards likewise are appropriately tailored to the
interests behind the rule and do not unreasonably burden speech. Dual
modality has already been discussed, and as noted, research indicates
that using this technique to present risk information improves consumer
risk comprehension and recall--advancing the Government interest--
without decreasing the recall or comprehension of benefit information,
thus reinforcing the reasonableness of this requirement. (See Sec.
202.1(e)(1)(ii)(C).)
The last standard, in Sec. 202.1(e)(1)(ii)(E), is a common-sense
measure that adds to the others to help ensure that consumers notice,
attend to, and understand the major statement by prohibiting the
simultaneous presentation of other audio or visual elements, alone or
in combination, that are likely to interfere with comprehension of the
major statement. This requirement applies only during the limited part
of the ad that presents the major statement, placing no restrictions on
any other part of the ad. Even during the presentation of the major
statement, it does not categorically prohibit other audio or visual
elements. In sum, these measures to advance the substantial Government
interests in communicating the major side effects and contraindications
of a prescription drug advertised to consumers satisfy the framework
for analysis described in Central Hudson and are consistent with the
First Amendment.
FDA has considered and rejects the suggestion in the comments that
the Government interests that justify this rule are adequately advanced
by the requirement to obtain a prescription from an HCP to access a
prescription drug. The comments do not recognize consumers as active
participants in their own healthcare, and do not address the Government
interest in helping to ensure that consumers are better informed when
they participate in healthcare decision making. This Government
interest is not completely or sufficiently addressed by the requirement
to obtain a prescription or visit an HCP before accessing a
prescription drug. Both before and after contact with an HCP, consumers
are frequently exposed to DTC TV/radio ads describing the drug's
benefits. Requiring that such ads also convey the advertised product's
risks better advances the substantial Government interests than
reliance on the HCP alone. For example, for a patient already taking a
prescribed drug, certain side effects may occur at any time, and
presenting information about that drug's risks in DTC ads provides the
patient with information about the side effects each time they
encounter the ad. Providing this information helps ensure that
consumers are better informed about side effects that they may
experience in connection with their use of the drug. Furthermore, the
assumption in comments that HCPs or ``prescription orders'' will
communicate prescription drug risks to consumers does not dispute that
consumers should be informed of those risks. Rather, it
[[Page 80978]]
appears to suggest that it is appropriate for a pharmaceutical firm to
benefit from advertising its prescription drug's positive attributes
directly to consumers while placing the entire burden of informing
consumers about that advertised drug's risks on other members of the
healthcare system. The First Amendment does not compel us to adopt that
policy.
One of the comments also cited Western States, in which the Court
applied the Central Hudson test to evaluate the advertising restriction
at issue (535 U.S. 375 at 368-77). In an analysis that broke no ``new
ground'' (id. at 368), the Court explained that, in general, the
Government should not restrict the communication of truthful and non-
misleading information for the sole purpose of preventing members of
the public from making bad decisions with the information (id. at 374).
That holding and rationale has no application to this rule, where
formatting and presentation requirements help ensure the effective
disclosure of information to the public.
Finally, with regard to the mention of prior restraint in the
context of the comment on dual modality, we disagree that this rule
presents any constitutional infirmity under that analysis. The
fundamental concern of the prior restraint doctrine is with Government
censorship in advance of publication. See Southeastern Promotions, Ltd.
v. Conrad, 420 U.S. 546, 553 (1975). Here, however, neither the dual
modality requirement nor any other aspect of this rule requires a firm
to seek any permission from FDA before running an ad or otherwise
enjoins speech before it occurs, and therefore the regulation does not
impose a prior restraint. See, e.g., Alexander v. United States, 509
U.S. 544, 549-553 (1993).
M. Role of Healthcare Professional--Comments and FDA Response
(Comment 23) One comment asserted that too much information in the
major statement can make it difficult for the audience to comprehend
the information and that the role of the prescribing HCP as a learned
intermediary is an important consideration in determining the relevancy
of risk information to be included in a DTC broadcast ad.
Another comment says that because doctors are responsible for their
patient's care and well-being, prescription drug ads should be required
to include--``instead of a clear, conspicuous, and neutral statement of
effects and contraindications''--a statement ``that only a patient's
doctor can fully provide this vital information.''
(Response 23) This rulemaking does not change the content of the
major statement, but focuses on the manner of presenting it in DTC TV/
radio ads. Further, FDA acknowledges the role of HCPs regarding
prescription drugs; however, as discussed in section III.A of this
document, that role does not completely address the reasons to require
prescription drug firms to communicate risk information about their
products in a clear, conspicuous, and neutral manner in DTC TV/radio
ads that communicate the benefits of such products.
N. Costs--Comments and FDA Response
(Comment 24) One comment states that the specific dollar estimates
to revise any ad with a life cycle extending beyond the compliance date
of the final rule were optimistically low and questions how FDA or its
industry sources arrived at these estimates. Furthermore, the comment
requests that FDA revisit the cost estimates (and publish a more
detailed analysis) to make certain that they accurately reflect the
costs that firms will incur in bringing their existing campaigns into
compliance. As part of addressing costs, the comment requests that FDA
consider a longer effective date.
(Response 24) No comments included quantified costs that firms will
incur in bringing their existing campaigns into compliance. With regard
to the request for an updated estimate of costs, we direct readers to
the Regulatory Impact Analysis (Ref. 66), which evaluates the
anticipated costs to firms for complying with this rule. In light of
concerns regarding costs, FDA has agreed to a compliance date of 365
days after the date of the final rule publication for all ads. (See
section VI of this document.)
O. Enforcement--Comments and FDA Response
(Comment 25) One comment suggests that FDA should enforce these
standards through civil monetary penalties (CMPs) for misleading DTC
advertising, as authorized under 21 U.S.C. 333(g)(1).
(Response 25) Failure to follow this rule will render a drug
misbranded under 21 U.S.C. 352(n). The Agency will have all compliance
tools associated with its authority available to enforce these
provisions; see generally the FD&C Act sections 301 (prohibited acts),
302 (21 U.S.C. 332) (injunction proceedings), and 303 (penalties),
including, as applicable, CMPs for false or misleading DTC ads
authorized under section 303(g)(1) of the FD&C Act (21 U.S.C.
333(g)(1)).
VI. Effective/Compliance Dates
This rule is effective May 20, 2024. The compliance date is
November 20, 2024.
As described in the proposed rule, in accordance with FDAAA, the
statutory requirement that the major statement in human prescription
drug advertisements presented directly to consumers in television or
radio format and stating the name of the drug and its conditions of use
be presented in a clear, conspicuous, and neutral manner has been in
effect since March 25, 2008 (75 FR 15376 at 15380). In the proposed
rule, FDA proposed that the standards in the final rule would become
effective 90 days after the publication of the final rule in the
Federal Register.
(Comment 26) One comment supports the 90-day proposal. Two comments
request the earliest possible implementation of the proposed standards.
Another comment agrees that 90 days is reasonable for DTC ads that have
not already begun production. However, the comment suggests 180 days
for ads that are already in production or circulation because it allows
time for modifications if required.
(Response 26) Based on comments, FDA agrees that it is appropriate
to provide a longer period for implementation than originally proposed.
We therefore make the effective date 180 days after publication.
Affected firms are encouraged to comply as soon as possible after the
effective date. However, we recognize that this rule could impact
existing ads, ads in production, and distribution agreements.
Accordingly, we now conclude that a compliance date of 365 days after
the date of publication of the final rule is appropriate to enable
firms to bring all ads subject to this rule into compliance without
undue burden. One schedule of 365 days after publication of the final
rule for compliance is clearer and easier to administer than having two
different schedules depending on where the ad is in production or on
other factors. While we did not receive data to support an alternative
estimate of costs, given the complexities of distribution agreements
and concerns raised with costs, we have also determined that a longer
time for implementation is appropriate.
VII. Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, Executive Order 14094, the
Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional
[[Page 80979]]
Review Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C.
801, Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4).
Executive Orders 12866, 13563, and 14094, direct us to assess all
benefits, costs and transfers of available regulatory alternatives and,
when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts;
and equity). Rules are ``significant'' under Executive Order 12866,
section 3(f)(1) (as amended by Executive Order 14094), if they ``have
an annual effect on the economy of $200 million or more (adjusted every
3 years by the Administrator of the Office of Information and
Regulatory Affairs (OIRA) for changes in gross domestic product); or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, territorial, or tribal governments
or communities.'' OIRA has determined that this final rule is not a
significant regulatory action under Executive Order 12866, section
3(f)(1).
Because this rule is likely to result in an annual effect on the
economy of $100 million or more or meets other criteria specified in
the Congressional Review Act/Small Business Regulatory Enforcement
Fairness Act, OIRA has determined that this rule does fall within the
scope of 5 U.S.C. 804(2).
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the estimated costs of compliance in the first year
could exceed 1 percent of sales revenues for the smallest affected
entities, we find that the final rule will have a significant economic
impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $177
million, using the most current (2022) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.
Under section 502(n) of the FD&C Act, as amended by section
901(d)(3)(A) of FDAAA, Congress has mandated that the disclosure of the
major side effects and contraindications of the advertised product
(known as the ``major statement'') in human prescription drug ads
presented directly to consumers in TV or radio format stating the name
of the drug and its conditions of use be presented in a ``clear,
conspicuous, and neutral manner.'' Section 901(d)(3)(B) of FDAAA
mandates that FDA issue regulations that establish standards for
determining whether a major statement is presented in such a manner. In
accordance with this legislation, this final rule requires that the
major statement in such ads be presented in a clear, conspicuous, and
neutral manner and provides standards for determining whether this is
the case.
B. Summary of Costs and Benefits
The costs of this final rule include the cost to read and
understand the rule, to revise a firm's standard operating procedures,
and to revise DTC TV/radio ads during the transition period leading up
to the compliance date. These activities and their associated costs
will occur during the first year. We also expect there to be modest
ongoing costs for industry to review future DTC TV/radio ads to ensure
that these ads comply with this final rule and an ongoing opportunity
cost related to a potential change in the relative allocation of time
within the ad between the presentation of the major statement and the
presentation of other content. The total present value of costs over a
10-year time horizon ranges from $104.8 million to $331.8 million, with
a primary estimate of $218.3 million, at a 7 percent discount rate; the
present value ranges from $123.8 million to $393.0 million, with a
primary estimate of $258.4 million, at a 3 percent discount rate.
Annualized costs over a 10-year time horizon range from $14.9 million
to $47.2 million, with a primary estimate of $31.1 million at a 7
percent discount rate; annualized costs over a 10-year time horizon
range from $14.5 million to $46.1 million, with a primary estimate of
$30.3 million at a 3 percent discount rate.
The benefits of this final rule stem from and include helping
consumers notice, attend to, and understand the major statement in DTC
TV/radio ads. The standards in the final rule help to ensure that DTC
TV/radio ads convey a truthful and non-misleading net impression about
the advertised drug and help ensure that consumers are better informed
when they participate in healthcare decisionmaking.
Table 1 summarizes the annualized costs and describes the benefits
of this final rule.
Table 1--Summary of Benefits, Costs, and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
------------------------------------
Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $millions/year........ .......... .......... .......... .......... 7 ..........
.......... .......... .......... .......... 3 ..........
Annualized Quantified...................... .......... .......... .......... .......... 7 ..........
.......... .......... .......... .......... 3 ..........
--------------------------------------------------------------------------------------------------------
Qualitative................................ Helping consumers notice, attend to, and understand the
major statement in DTC TV/radio ads
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized $millions/year........ 31.1 14.9 47.2 2020 7 10
30.3 14.5 46.1 2020 3 10
Annualized Quantified...................... .......... .......... .......... .......... 7 ..........
.......... .......... .......... .......... 3 ..........
--------------------------------------------------------------------------------------------------------
Qualitative................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
[[Page 80980]]
Federal Annualized Monetized $millions/year .......... .......... .......... .......... 7 ..........
.......... .......... .......... .......... 3 ..........
--------------------------------------------------------------------------------------------------------
From/To.................................... From:
To:
--------------------------------------------------------------------------------------------------------
Other Annualized Monetized $millions/year.. .......... .......... .......... .......... 7 ..........
.......... .......... .......... .......... 3 ..........
--------------------------------------------------------------------------------------------------------
From/To.................................... From:
To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government: None.............................................................................................................
Small Business: Compliance costs in the first year may exceed 1 percent of revenues for the smallest affected entities..............................
Wages: None.........................................................................................................................................
Growth: None........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (docket number
FDA-2009-N-0582) (Ref. 66) and at <a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>.
VIII. Analysis of Environmental Impact
We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
IX. Paperwork Reduction Act of 1995
This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The title,
description, and respondent description of the information collection
provisions are shown in the following paragraphs with an estimate of
the annual third-party disclosure burden. Included in the estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
Title: Prescription Drug Advertisements.
Description: Under Sec. 202.1, FDA has established requirements
for ads for human prescription drug and biological products and ads for
animal prescription drugs. The regulations apply to ads including those
published in journals, magazines, other periodicals, and newspapers and
those broadcast through media, such as radio, TV, and telephone
communication systems. Under Sec. 202.1(e)(1), FDA's regulations
describe when a true statement of information in brief summary relating
to side effects, contraindications, and effectiveness is required. In
this final rule, the Agency amends these regulations. Specifically,
under Sec. 202.1(e)(1)(ii), FDA implements section 502(n) as amended,
which requires that in human prescription drug advertisements presented
directly to consumers in television or radio format and stating the
name of the drug and its conditions of use, the major statement
relating to side effects and contraindications must be presented in a
clear, conspicuous, and neutral manner. The rule also includes
standards for determining whether the major statement is presented in a
clear, conspicuous, and neutral manner.
General requirements for prescription drug ads to include a true
statement of information in brief summary relating to side effects,
contraindications, and effectiveness are located in the opening
paragraph of Sec. 202.1(e), and specific provisions for prescription
drug ads broadcast through media such as radio, TV, or telephone
communications systems addressing inclusion of the major statement and
adequate provision of the approved labeling are located in Sec.
202.1(e)(1)(i). These provisions were already in effect and approved
under OMB control number 0910-0686. The requirements of Sec.
202.1(e)(1), including these existing requirements and new requirements
imposed by this final rule in Sec. 202.1(e)(1)(ii)--which address only
the manner of presentation of the major statement in certain ads while
retaining the pre-existing content requirements--collectively mandate
that ads disclose information to the public and thus are subject to the
Paperwork Reduction Act of 1995.
Description of Respondents: Respondents to the collection of
information are manufacturers, packers, and distributors; application
holders and their representatives with approved new drug applications
(NDAs), abbreviated new drug applications (ANDAs), and biologics
licensing applications (BLAs) for human prescription drugs; and those
that market prescription drugs for human use without an approved
application.
Based on a recent review of data collected via FDA Form 2253
advertisement submissions, we revised our previously estimated burden
of this information collection. Specifically, relying on data from
calendar year 2020 Form 2253 submissions, we increased the number of
corresponding disclosures and recalculated the burden as an increase to
the existing burden, using the most recent numbers for that burden
estimate, under the approved OMB control number 0910-0686 collection
covering the regulations under Sec. 202.1. The collections of
information pertaining to FDA Form 2253 (``Transmittal of
Advertisements and Promotional Labeling for Drugs and Biologics for
Human Use,'' located on the FDA website at <a href="https://www.fda.gov/about-fda/reports-manuals-forms/forms">https://www.fda.gov/about-fda/reports-manuals-forms/forms</a>) are approved under OMB control numbers
0910-0001 and 0910-0338.
FDA estimates the burden of the collections of information as
follows:
[[Page 80981]]
Table 2--Estimated Burden Resulting From Revising TV/Radio Ads To Comply With 21 CFR 202.1(e)(1)
----------------------------------------------------------------------------------------------------------------
Number of Hourly
21 CFR 202.1--Prescription drug Number of disclosures per Total annual burden per Total
marketing respondents respondent disclosures disclosure hours
----------------------------------------------------------------------------------------------------------------
One-time activities: reading and 57 3 171 2.5 427.5
understanding rule, revising company
SOPs, modifying existing ads (if
necessary)..........................
202.1(e)(1)(ii): Ongoing 57 11.02 628 5 3,140
implementation of revised
requirements for future TV and radio
ads.................................
--------------------------------------------------------------------------
Total............................ .............. ................. 799 ........... 3,567.5
----------------------------------------------------------------------------------------------------------------
According to this 2020 submission data from the Center for Drug
Evaluation and Research (CDER), we estimate 564 DTC TV ads for
prescription drugs will be prepared by 37 firms under Sec.
202.1(e)(1)(ii) annually. Likewise, based on data from the Center for
Biologics Evaluation and Research (CBER), we estimate that six DTC TV
ads will be prepared by three firms annually. Our total estimated
number of DTC TV ads under Sec. 202.1(e)(1)(ii), then, is 570. Based
on our experience with reviewing DTC TV ads, we believe an expenditure
of approximately 5 hours per disclosure should be sufficient to ensure
that the major statement in DTC TV ads is presented in a clear,
conspicuous, and neutral manner in accordance with the requirements of
this final rule.
Also based on data from CDER, we estimate 56 DTC radio ads for
prescription drugs will be prepared by 16 firms under Sec.
202.1(e)(1)(ii) annually. Based on data from CBER, we estimate two DTC
radio ads will be prepared by one firm annually. The total estimated
number of DTC radio ads subject to disclosures under Sec.
202.1(e)(1)(ii), then, is 58. Based on our experience reviewing DTC
radio ads, we believe an expenditure of approximately 5 hours per
disclosure should satisfy the requirements in Sec. 202.1(e)(1)(ii).
In sum, as shown in table 2, FDA estimates that, annually, 57
respondents will submit DTC TV or radio ads, resulting in 628
disclosures. FDA estimates 5 hours per disclosure will satisfy the
requirements, resulting in an estimated annual expenditure of 3,140
hours. In addition, as noted in the table, FDA estimates that, for
those 57 respondents, there will be a one-time burden of 427.5 hours.
The information collection provisions in this final rule have been
submitted to OMB for review as required by section 3507(d) of the
Paperwork Reduction Act of 1995.
Before the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.
X. Federalism
We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.
XI. Consultation and Coordination With Indian Tribal Governments
We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive order and, consequently, a
tribal summary impact statement is not required.
XII. References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without asterisks are not on public
display at <a href="https://www.regulations.gov">https://www.regulations.gov</a> because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.
*1. FDA, Guidance for Industry, ``Consumer-Directed Broadcast
Advertisements,'' August 1999, available at <a href="https://www.fda.gov/media/75406/download">https://www.fda.gov/media/75406/download</a>, accessed July 12, 2022.
*2. DeFrank, J.T., N. Berkman, L. Kahwati, et al., ``Direct-to-
Consumer Advertising of Prescription Drugs and the Patient-
Prescriber Encounter: A Systematic Review,'' Health Communication,
35(6):739-746, 2020, doi:10.1080/10410236.2019.1584781.
3. Kornfield, R., J. Donohue, E.R. Berndt, et al., ``Promotion of
Prescription Drugs to Consumers and Providers, 2001-2010,'' PLOS
ONE, 8(3):e55504, 2013, doi:10.1371/journal.pone.0055504.
4. Kornfield, R., G.C. Alexander, D.M. Qato, et al., ``Trends in
Exposure to Televised Prescription Drug Advertising, 2003-2011,''
American Journal of Preventive Medicine, 48(5):575-579, 2015,
doi:10.1016/j.amepre.2014.12.001.
*5. Sullivan, H.W. and M. Campbell, ``Do Prescription Drug Ads Tell
Consumers Enough About Benefits and Side Effects? Results from the
Health Information National Trends Survey, Fourth Administration,''
Journal of Health Communication, 20(12):1391-1396, 2015,
doi:10.1080/10810730.2015.1018635.
6. Koo, K. and R.L. Yap, ``Trends in Urological Direct-to-Consumer
Advertising During Prime-Time Television News Programs,'' Urology
Practice, 4(1):7-13, 2017, doi:10.1016/j.urpr.2016.03.005.
*7. U.S. Congressional Research Service, ``Direct-to-Consumer
Advertising of Prescription Drugs,'' Report R40590, May 20, 2009.
Available at <a href="https://crsreports.congress.gov/product/pdf/R/R40590">https://crsreports.congress.gov/product/pdf/R/R40590</a>.
8. Medical Marketing and Media, ``How DTC spending shifted in
2020,'' March 25, 2021, available at <a href="https://www.mmm-online.com/home/channel/features/how-dtc-spending-shifted-in-2020/">https://www.mmm-online.com/home/channel/features/how-dtc-spending-shifted-in-2020/</a>, accessed
July 12, 2023.
9. Bulik, B., ``The Top 10 Ad Spenders in Big Pharma for 2020,''
Fierce Pharma, April 19, 2021, available at https://
www.fiercepharma.com/special-report/
[[Page 80982]]
top-10-ad-spenders-big-pharma-for-2020, accessed September 27, 2022.
*10. Applequist, J. and J.G. Ball, ``An Updated Analysis of Direct-
to-Consumer Television Advertisements for Prescription Drugs,''
Annals of Family Medicine, 16(3):211-216, 2018, doi:10.1370/
afm.2220.
11. PhRMA, ``PhRMA Guiding Principles: Direct to Consumer
Advertisements About Prescription Medicines,'' 2008, revised October
2018.
12. DiJulio, B., J. Firth, and M. Brodie, ``Kaiser Health Tracking
Poll: October 2015,'' Kaiser Family Foundation, October 28, 2015,
available at <a href="https://www.kff.org/health-costs/poll-finding/kaiser-health-tracking-poll-october-2015">https://www.kff.org/health-costs/poll-finding/kaiser-health-tracking-poll-october-2015</a>, accessed July 12, 2022.
13. Princeton Survey Research Associates International for PhRMA,
``2017 Direct-to-Consumer Advertising Survey Results,'' July 18,
2017, available at <a href="https://phrma.org/resource-center/Topics/Medicine-Safety/2017-Direct-to-Consumer-Advertising-Survey-Results">https://phrma.org/resource-center/Topics/Medicine-Safety/2017-Direct-to-Consumer-Advertising-Survey-Results</a>,
accessed July 12, 2022.
14. Lee, M., K.W. King, and L.N. Reid, ``Factors Influencing
Consumers' Attitudinal and Behavioral Responses to Direct-To-
Consumer and Over-the-Counter Drug Advertising,'' Journal of Health
Communication, 20(4):431-444, 2015, doi:10.1080/
10810730.2014.965367.
*15. Aikin, K.J, J.L. Swasy, and A.C. Braman, ``Patient and
Physician Attitudes and Behaviors Associated With DTC Promotion of
Prescription Drugs--Summary of FDA Survey Research Results, Final
Report,'' November 19, 2004, available at <a href="https://www.fda.gov/files/drugs/published/Patient-and-Physician-Attitudes-and-Behaviors-Associated-With-DTC-Promotion-of-Prescription-Drugs-Final-Report.pdf">https://www.fda.gov/files/drugs/published/Patient-and-Physician-Attitudes-and-Behaviors-Associated-With-DTC-Promotion-of-Prescription-Drugs-Final-Report.pdf</a>, accessed July 12, 2022.
*16. Eastern Research Group, Inc., ``Scientific Literature on
Direct-to-Consumer Advertising of Prescription Pharmaceuticals,
2004-2008: Literature Review,'' January 2009.
17. Weissman, J.S., D. Blumenthal, A.J. Silk, et al., ``Consumers'
Reports on the Health Effects of Direct-to-Consumer Drug
Advertising,'' Health Affairs, 22(Suppl1):W3-82-W3-95, 2003.
18. Avery, R.J., M. Eisenberg, and K.I. Simon, ``Fair Balance in
Direct-to-Consumer Antidepressant Print and Television Advertising,
1995-2007,'' Journal of Health Communication, 17(3):250-277, 2012,
doi:10.1080/10810730.2011.585698.
19. Schwartz, L.M. and S. Woloshin, ``Communicating Uncertainties
About Prescription Drugs to the Public: A National Randomized
Trial,'' Archives of Internal Medicine, 171(16):1463-1468, 2011,
doi:10.1001/archinternmed.2011.396.
20. Donahue, R., D. Russell, C. de Riese, et al., ``Patients Willing
to Wait: Arrival Time, Wait Time, and Patient Satisfaction in an
Ambulatory Urology Clinic,'' Urology Practice, 4(1):1-6, 2017.
21. Tai-Seale, M., T.G. McGuire, and W. Zhang, ``Time Allocation in
Primary Care Office Visits,'' Health Services Research, 42(5):1871-
1894, 2007, doi:10.1111/j.1475-6773.2006.00689.x.
22. Young, R.A., S.K. Burge, K.A. Kumar, et al., ``A Time-Motion
Study of Primary Care Physicians' Work in the Electronic Health
Record Era,'' Family Medicine, 50(2):91-99, 2018, doi:10.22454/
FamMed.2018.184803.
23. Murray, E., B. Lo, L. Pollack, et al., ``Direct-to-Consumer
Advertising: Physicians' Views of Its Effects on Quality of Care and
the Doctor-Patient Relationship,'' The Journal of the American Board
of Family Practice, 16(6):513-524, 2003, doi:10.3122/jabfm.16.6.513.
24. Fassiotto, M., C. Simard, C. Sandborg, et al., ``An Integrated
Career Coaching and Time-Banking System Promoting Flexibility,
Wellness, and Success: A Pilot Program at Stanford University School
of Medicine,'' Academic Medicine, 93(6):881-887, 2018, doi:10.1097/
ACM.0000000000002121.
25. Sinsky, C., L. Colligan, L. Li, et al., ``Allocation of
Physician Time in Ambulatory Practice: A Time and Motion Study in 4
Specialties,'' Annals of Internal Medicine, 165(11):753-760, 2016,
doi:10.7326/M16-0961.
*26. FDA, Draft Guidance for Industry, ``Presenting Risk Information
in Prescription Drug and Medical Device Promotion,'' May 2009,
available at <a href="https://www.fda.gov/media/76269/download">https://www.fda.gov/media/76269/download</a>, accessed July
12, 2022.
*27. FDA, Center for Drug Evaluation and Research, ``Experimental
Evaluation of the Impact of Distraction on Consumer Understanding of
Risk and Benefit Information in Direct-to-Consumer Prescription Drug
Television Advertisements: Technical Research Report,'' May 2011,
available at <a href="https://www.regulations.gov/document/FDA-2009-N-0582-0040">https://www.regulations.gov/document/FDA-2009-N-0582-0040</a>, accessed July 12, 2022.
28. Lavie, N., ``Capacity Limits in Selective Attention: Behavioral
Evidence and Implications for Neural Activity,'' Visual Attention
and Cortical Circuits, ed. Braun, J., C. Kock, and J.L. Davis, MIT
Press, 2001, pp. 49-68.
29. Miller, G.A., ``The Magical Number Seven, Plus or Minus Two:
Some Limits on Our Capacity for Processing Information,''
Psychological Review, 63(2):81-97, 1956, doi:10.1037/h0043158.
30. Shapiro, K., ``Temporal Methods for Studying Attention: How Did
We Get Here and Where Are We Going?'' The Limits of Attention:
Temporal Constraints in Human Information Processing, ed. Shapiro,
K., Oxford University Press, 2001, pp. 1-19.
31. Hillstrom, A.P. and Y.C. Chai, ``Factors That Guide or Disrupt
Attentive Visual Processing,'' Computers in Human Behavior,
22(4):648-656, 2006, doi:10.1016/j.chb.2005.12.003.
32. Petty, R.E., G.L. Wells, and T.C. Brock, ``Distraction Can
Enhance or Reduce Yielding to Propaganda: Thought Disruption Versus
Effort Justification,'' Journal of Personality and Social
Psychology, 34(5):874-884, 1976, doi:10.1037/0022-3514.34.5.874.
*33. Zimbardo, P., M. Snyder, J. Thomas, et al., ``Modifying the
Impact of Persuasive Communications with External Distraction,''
Journal of Personality and Social Psychology, 16(4):669-680, 1970,
doi:10.1037/h0030065.
34. Manrai, L.A., A.K. Manrai, and N. Murray, ``Comprehension of
Info-Aid Supers in Television Advertising for Social Ideas:
Implications for Public Policy,'' Journal of Business Research,
30(1):75-84, 1994, doi:10.1016/0148-2963(94)90070-1.
35. Furnham, A. and L. Strbac, ``Music is as Distracting as Noise:
The Differential Distraction of Background Music and Noise on the
Cognitive Test Performance of Introverts and Extraverts,''
Ergonomics, 45(3):203-217, 2002, doi:10.1080/00140130210121932.
36. Mackie, D.M. and L.T. Worth, ``Processing Deficits and the
Mediation of Positive Affect in Persuasion,'' Journal of Personality
and Social Psychology, 57(1):27-40, 1989, doi:10.1037//0022-
3514.57.1.27.
37. Regan, D.T. and J.B. Cheng, ``Distraction and Attitude Change: A
Resolution,'' Journal of Experimental Social Psychology, 9(2):138-
147, 1973, doi:10.1016/0022-1031(73)90005-X.
38. Hoyer, W.D., R.K. Srivastava, and J. Jacoby, ``Sources of
Miscomprehension in Television Advertising,'' Journal of
Advertising, 13(2):17-26, 1984, doi:10.1080/00913367.1984.10672883.
39. Cassidy, G. and R.A.R. MacDonald, ``The Effect of Background
Music and Background Noise on the Task Performance of Introverts and
Extraverts,'' Psychology of Music, 35(3):517-537, 2007, doi:10.1177/
0305735607076444.
*40. CCH Trade Regulation Reporter, Paragraph 7569.09, ``Clear and
Conspicuous Disclosure,'' October 21, 1970.
41. C.A. Depp, D.A. Schkade, W.K. Thompson, D.V. Jeste, ``Age,
Affective Experience, and Television Use,'' American Journal of
Preventive Medicine, 39:173-178, 2010. doi:10.1016/
j.amepre.2010.03.020
*42. Gu Q., C.F. Dillon, and V.L. Burt, ``Prescription Drug Use
Continues To Increase: U.S. Prescription Drug Data for 2007-2008.''
NCHS Data Brief. 2010;42:1-8.
*43. O'Donoghue, A.C., M. Johnson, H.W. Sullivan, et al., ``Aging
and Direct-to-Consumer Prescription Drug Television Ads: The Effects
of Individual Differences and Risk Presentation,'' Journal of Health
Communication, 24(4), 368-376, 2019, doi:10.1080/
10810730.2019.1606364
44. Adams, A.S. and J. Edworthy, ``Quantifying and Predicting the
Effects of Basic Text Display Variables on the Perceived Urgency of
Warning Labels: Tradeoffs Involving Font Size, Border
[[Page 80983]]
Weight, and Color,'' Ergonomics, 38(11):2221-2237, 1995,
doi:10.1080/00140139508925264.
45. Arditi, A. and J. Cho, ``Serifs and Font Legibility,'' Vision
Research, 45(23):2926-2933, 2005, doi:10.1016/j.visres.2005.06.013.
* 46. Baker, S., ``Provision of Effective Information,'' British
Dental Journal, 201(2):100, 2006, doi:10.1038/sj.bdj.4813825.
47. Sheedy, J.E., M.V. Subbaram, A.B. Zimmerman, et al., ``Text
Legibility and the Letter Superiority Effect,'' Human Factors,
47(4):797-815, 2005, doi:10.1518/001872005775570998.
48. Tantillo, J., J. Di Lorenzo-Aiss, and R.E. Mathisen,
``Quantifying Perceived Differences in Type Styles: An Exploratory
Study,'' Psychology & Marketing, 12(5):447-457, 1995, doi:10.1002/
mar.4220120508.
49. Wogalter, M.S. and W.J. Vigilante, ``Effects of Label Format on
Knowledge Acquisition and Perceived Readability by Younger and Older
Adults,'' Ergonomics, 46(4):327-344, 2003, doi:10.1080/
0014013021000048006.
* 50. H. Rept. No. 102-839, August 11, 1992.
51. Bither, SW and P.L. Wright, ``The Self-Confidence-Advertising
Response Relationship: A Function of Situational Distraction,''
Journal of Marketing Research, 10(2):146-152, 1973, doi:10.1177/
002224377301000204.
52. Fraser, C. and J.A. Bradford, ``Music to Your Brain: Background
Music Changes Are Processed First, Reducing Ad Message Recall,''
Psychology & Marketing, 30(1):62-75, 2013, doi:10.1002/mar.20580.
53. Thomas, V., K. Fowler, and R.H. Kolbe, ``The Implications of the
FTC's Clear and Conspicuous Standards for the Communication of
Credit Card Information to Young Consumers,'' Journal of Financial
Services Marketing, 16(3-4):195-209, 2011, doi:10.1057/fsm.2011.22.
54. Aikin, K.J., A.C. O'Donoghue, C.M. Squire, et al., ``An
Empirical Examination of the FDAAA-Mandated Toll-Free Statement for
Consumer Reporting of Side Effects in Direct-to-Consumer Television
Advertisements,'' Journal of Public Policy and Marketing, 35(1):108-
123, 2016, doi:10.1509/jppm.14.077.
* 55. Sullivan, H.W., V. Boudewyns, A.C. O'Donoghue, et al.,
``Attention to and Distraction from Risk Information in Prescription
Drug Advertising: An Eye-Tracking Study,'' Journal of Public Policy
and Marketing, 36(2):236-245, 2017, doi:10.1509/jppm.16.013.
56. Wolgalter, M.S., E.F. Shaver, and M.J. Kalsher, ``Effect of
Presentation Modality in Direct-to-Consumer (DTC) Prescription Drug
Television Advertisements,'' Applied Ergonomics, 45(5):1330-1336,
2014, doi:10.1016/j.apergo.2013.12.003.
57. Galotti, K.M., Cognitive Psychology: In and Out of the
Laboratory, 3rd ed., Wadsworth/Thomson Learning, 2004.
58. Paivio, A., ``The Empirical Case for Dual Coding,'' Imagery,
Memory, and Cognition: Essays in Honor of Allan Paivio, ed. Yuille,
J.C., Psychology Press, 1983, pp. 307-332.
59. Wang, A. and D.D. Muehling, ``The Effects of Audio-Visual and
Visual-Only Cues on Consumers' Responses to Co-Branded
Advertising,'' Journal of Marketing Communications, 16(5):307-324,
2010, doi:10.1080/13527260902970190.
60. Brewer, N., S. Harvey, and C. Semmler, ``Improving Comprehension
of Jury Instructions With Audio-Visual Presentation,'' Applied
Cognitive Psychology, 18(6):765-776, 2004, doi:10.1002/acp.1036.
61. Chung, K.K.H., ``What Effect Do Mixed Sensory Mode Instructional
Formats Have on Both Novice and Experienced Learners of Chinese
Characters?'' Learning and Instruction, 18(1):96-108, 2008,
doi:10.1016/j.learninstruc.2007.01.001.
62. Frick, R.W., ``Using Both an Auditory and a Visual Short-Term
Store to Increase Digit Span,'' Memory & Cognition, 12(5):507-514,
1984, doi:10.3758/BF03198313.
63. Lang, A., ``Defining Audio/Video Redundancy from a Limited-
Capacity Information Processing Perspective,'' Communication
Research, 22(1):86-115, 1995, doi:10.1177/009365095022001004.
64. Walma van der Molen, J.H. and M.E. Klijn, ``Recall of Television
Versus Print News: Retesting the Semantic Overlap Hypothesis,''
Journal of Broadcasting & Electronic Media, 48(1):89-107, 2004,
doi:10.1207/s15506878jobem4801_5.
* 65. FTC, ``Commission Enforcement Policy Statement Regarding Clear
and Conspicuous Disclosures in Television Advertising,'' October 21,
1970, available at <a href="https://www.ftc.gov/public-statements/1970/10/commission-enforcement-policy-statement-regarding-clear-conspicuous">https://www.ftc.gov/public-statements/1970/10/commission-enforcement-policy-statement-regarding-clear-conspicuous</a>,
accessed July 12, 2022.
* 66. FDA, Economic Analysis of Impacts, Direct-to-Consumer
Prescription Drug Advertisements: Presentation of the Major
Statement in Television and Radio Advertisements in a Clear,
Conspicuous, and Neutral Manner, 2023, available at <a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>.
List of Subjects in 21 CFR Part 202
Advertising, Prescription drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
202 is amended as follows:
PART 202--PRESCRIPTION DRUG ADVERTISING
0
1. The authority citation for part 202 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 352, 355, 360b, 371.
0
2. In Sec. 202.1, add introductory text and revise paragraph (e)(1) to
read as follows:
Sec. 202.1 Prescription-drug advertisements.
Prescription drug as used in this section means any drug defined in
section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act or Sec.
201.105 of this chapter, applicable to drugs intended for use by humans
and to veterinary drugs, respectively.
* * * * *
(e) * * *
(1) When required. All advertisements for any prescription drug, except
advertisements described in paragraph (e)(2) of this section, must
present a true statement of information in brief summary relating to
side effects, contraindications (when used in this section, ``side
effects, contraindications'' include side effects, warnings,
precautions, and contraindications and include any such information
under such headings as cautions, special considerations, important
notes, etc.), and effectiveness.
(i) Broadcast advertisements. Advertisements broadcast through media
such as radio, television, or telephone communications systems must:
(A) Include information relating to the major side effects and
contraindications (``major statement'') of the advertised drugs in the
audio or audio and visual parts of the presentation, unless required by
paragraph (e)(1)(ii)(C) of this section to present the major statement
using audio and text; and
(B) Contain a brief summary of all necessary information related to
side effects and contraindications, unless adequate provision is made
for dissemination of the approved or permitted product labeling in
connection with the broadcast presentation.
(ii) Human drug advertisements in television or radio format--Clear,
conspicuous, and neutral manner. For advertisements for prescription
drugs intended for use by humans presented directly to consumers in
television or radio format, the major statement must be presented in a
clear, conspicuous, and neutral manner. The major statement is
presented in a clear, conspicuous, and neutral manner if the following
are met:
(A) It is presented in consumer-friendly language and terminology that
is readily understandable.
[[Page 80984]]
(B) Its audio information, in terms of the volume, articulation, and
pacing used, is at least as understandable as the audio information
presented in the rest of the advertisement.
(C) In advertisements in television format, it is presented
concurrently using both audio and text (dual modality). To achieve dual
modality:
(1) Either the text displays the verbatim key terms or phrases from the
corresponding audio, or the text displays the verbatim complete
transcript of the corresponding audio; and
(2) The text is displayed for a sufficient duration to allow it to be
read easily. For purposes of the standard in this paragraph
(e)(1)(ii)(C)(2), the duration is considered sufficient if the text
display begins at the same time and ends at approximately the same time
as the corresponding audio.
(D) In advertisements in television format, for the text portion of the
major statement, the size and style of font, the contrast with the
background, and the placement on the screen allow the information to be
read easily.
(E) During the presentation of the major statement, the advertisement
does not include audio or visual elements, alone or in combination,
that are likely to interfere with comprehension of the major statement.
* * * * *
Dated: November 8, 2023.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2023-25428 Filed 11-20-23; 8:45 am]
BILLING CODE 4164-01-P
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