Rule2023-28530
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 Final Rule: Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability
Primary source
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Published
December 27, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "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 Final Rule: Questions and Answers." We are issuing this small entity compliance guide (SECG) in accordance with the Small Business Regulatory Enforcement Fairness Act to help small businesses understand and comply with the "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 Final Rule" (CCN Final Rule). The CCN Final Rule modifies FDA regulations to reflect the requirement in the Federal Food, Drug, and Cosmetic Act (FD&C Act) that human prescription drug advertisements presented directly to consumers (DTC) in television or radio format and stating the name of the drug and its conditions of use (DTC TV/radio ads) present the major statement relating to side effects and contraindications (major statement) in a clear, conspicuous, and neutral manner and establishes standards to help ensure this requirement is met. The term "drugs" in this guidance refers to prescription human drug and biological products.
Full Text
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<title>Federal Register, Volume 88 Issue 247 (Wednesday, December 27, 2023)</title>
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[Federal Register Volume 88, Number 247 (Wednesday, December 27, 2023)]
[Rules and Regulations]
[Pages 89303-89305]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-28530]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 202
Docket No. FDA-2009-N-0582]
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 Final Rule: Questions and
Answers; Guidance for Industry; Small Entity Compliance Guide;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a guidance for industry entitled
``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 Final Rule: Questions and
Answers.'' We are issuing this small entity compliance guide (SECG) in
accordance with the Small Business Regulatory Enforcement Fairness Act
to help small businesses understand and comply with the ``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 Final Rule'' (CCN Final Rule). The CCN
Final Rule modifies FDA regulations to reflect the requirement in the
Federal Food, Drug, and Cosmetic Act (FD&C Act) that human prescription
drug advertisements presented directly to consumers (DTC) in television
or radio format and stating the name of the drug and its conditions of
use (DTC TV/radio ads) present the major statement relating to side
effects and contraindications (major statement) in a clear,
conspicuous, and neutral manner and establishes standards to help
ensure this requirement is met. The term ``drugs'' in this guidance
refers to prescription human drug and biological products.
DATES: The announcement of the guidance is published in the Federal
Register on December 27, 2023.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and
[[Page 89304]]
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2009-N-0582 for ``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 Final Rule: Questions and Answers.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper 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 document, 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the SECG to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the SECG.
FOR FURTHER INFORMATION CONTACT: Suzanna Boyle, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3214, Silver Spring, MD 20993-0002, 301-
796-1200, <a href="/cdn-cgi/l/email-protection#40030405126d0f1004106d12100d002624216e2828336e272f36"><span class="__cf_email__" data-cfemail="0c4f48495e21435c485c215e5c414c6a686d2264647f226b637a">[email protected]</span></a>; or 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.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance for industry
entitled ``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 Final
Rule: Questions and Answers.'' FDA is issuing this SECG as a level 2
guidance, consistent with FDA's good guidance practices (GGP)
regulation (Sec. 10.115 (21 CFR 10.115)). Consistent with the GGP
regulation, FDA is immediately implementing the level 2 guidance and
inviting public comment (Sec. 10.115(g)(4)).
We are issuing this guidance in accordance with section 212 of the
Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121, as
amended by Pub. L. 110-28) to help small businesses understand and
comply with the CCN Final Rule (88 FR 80958, November 21, 2023). The
CCN Final Rule modifies 21 CFR 202.1(e)(1) to reflect the requirement
in section 502(n) of the FD&C Act (21 U.S.C. 352(n)) that human
prescription drug advertisements presented directly to consumers (DTC)
in television or radio format and stating the name of the drug and its
conditions of use (DTC TV/radio ads) present the major statement
relating to side effects and contraindications in a clear, conspicuous,
and neutral manner. The CCN Final Rule also establishes standards to
help ensure that this requirement is met.
This guidance addresses the content and effect of the CCN Final
Rule, including identifying which drugs and advertisements are covered
by the rule. The term ``drugs'' in this guidance refers to prescription
human drug and biological products. In addition, this guidance explains
when firms are expected to comply with the CCN Final Rule and how they
can do so. The term ``firms'' in this guidance refers to manufacturers,
packers, and distributors of any human prescription drug that, in any
State, is distributed or offered for sale and who advertise that drug,
and to all persons who they cause to issue any advertisement with
respect to their human prescription drug(s), including both individuals
and corporate entities.
This level 2 guidance is being issued consistent with FDA's good
guidance practices regulation (Sec. 10.115). The SECG represents the
current thinking of FDA on how small businesses can better understand
and comply with the ``Direct-to-Consumer Prescription Drug
Advertisements: Presentation of the Major Statement in a Clear,
Conspicuous, and Neutral Manner in Advertisements in Television or
Radio Format Final Rule.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR 202.1 have been approved under OMB control number 0910-0686.
The collections of information in 21 CFR 314.81(b)(3)(i) relating to
the submission of advertisements and promotional labeling have been
approved under OMB control number 0910-0001.
[[Page 89305]]
III. Electronic Access
Persons with access to the internet may obtain the SECG at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Use the FDA websites listed
in the previous sentence to find the most current version of the
guidance.
Dated: December 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28530 Filed 12-26-23; 8:45 am]
BILLING CODE 4164-01-P
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