Notice2023-13775
Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements; Guidance for Industry; Availability
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Published
June 28, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements." This guidance provides recommendations for presenting quantitative efficacy and risk information in DTC promotional labeling and advertisements for prescription human drug and biological products and prescription animal drugs and in DTC promotional labeling for over-the-counter (OTC) animal drugs (collectively, "promotional communications"). FDA is issuing this guidance to describe the Agency's recommendations for how manufacturers, distributors, and packers (collectively, "firms") that include quantitative efficacy or risk information about their drugs in DTC promotional communications can make the language and presentation more consumer-friendly. This guidance finalizes the draft guidance of the same title issued in October 2018.
Full Text
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<title>Federal Register, Volume 88 Issue 123 (Wednesday, June 28, 2023)</title>
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[Federal Register Volume 88, Number 123 (Wednesday, June 28, 2023)]
[Notices]
[Pages 41966-41967]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-13775]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-2613]
Presenting Quantitative Efficacy and Risk Information in Direct-
to-Consumer Promotional Labeling and Advertisements; Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Presenting
Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC)
Promotional Labeling and Advertisements.'' This guidance provides
recommendations for presenting quantitative efficacy and risk
information in DTC promotional labeling and advertisements for
prescription human drug and biological products and prescription animal
drugs and in DTC promotional labeling for over-the-counter (OTC) animal
drugs (collectively, ``promotional communications''). FDA is issuing
this guidance to describe the Agency's recommendations for how
manufacturers, distributors, and packers (collectively, ``firms'') that
include quantitative efficacy or risk information about their drugs in
DTC promotional communications can make the language and presentation
more consumer-friendly. This guidance finalizes the draft guidance of
the same title issued in October 2018.
DATES: The announcement of the guidance is published in the Federal
Register on June 28, 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 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-2018-D-2613 for ``Presenting Quantitative Efficacy and Risk
Information in Direct-to-Consumer (DTC) Promotional Labeling and
Advertisements.'' 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 this guidance 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; the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research,
[[Page 41967]]
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993-0002; or the Policy and Regulations Staff
(HFV-6), Center for Veterinary Medicine, Food and Drug Administration,
7500 Standish Pl., Rockville, MD 20855. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
FOR FURTHER INFORMATION CONTACT: Christine Bradshaw, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3203, Silver Spring, MD 20993-0002, 301-
796-1200, <a href="/cdn-cgi/l/email-protection#afecebeafd82e0ffebff82fdffe2efc9cbce81c7c7dc81c8c0d9"><span class="__cf_email__" data-cfemail="dd9e99988ff0928d998df08f8d909dbbb9bcf3b5b5aef3bab2ab">[email protected]</span></a>; Diane Maloney, 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; or Kathryn Dennehy, Center for Veterinary Medicine (HFV-
245), Food and Drug Administration, 7519 Standish Pl., Rockville, MD
20855, 301-837-7554, <a href="/cdn-cgi/l/email-protection#5b103a2f33292235751f3e35353e33221b3d3f3a75333328753c342d"><span class="__cf_email__" data-cfemail="5c173d28342e253272183932323934251c3a383d7234342f723b332a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Presenting Quantitative Efficacy and Risk Information in
Direct-to-Consumer (DTC) Promotional Labeling and Advertisements.''
This guidance describes recommendations for how firms including
quantitative efficacy or risk information about their drugs \1\ in DTC
promotional communications can make the language and presentation more
consumer-friendly. While this guidance focuses on quantitative
presentations of efficacy and risk information, firms may wish to refer
to these principles and recommendations for quantitative presentations
of other product benefits (keeping in mind that any such presentation
of other product benefits must comply with applicable statutory and
regulatory requirements).
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\1\ The term ``drugs'' in the guidance refers to prescription
human drug and biological products and to prescription and OTC
animal drugs.
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When describing efficacy and risk information about a drug in
promotional communications, firms generally have flexibility regarding
how they present this information as long as the presentation is not
false or misleading and complies with other applicable statutory and
regulatory requirements. FDA understands that firms may experience
challenges when determining how to present quantitative efficacy or
risk information in their DTC promotional communications so that
consumers have an opportunity to attend to, understand, and use the
information to form accurate perceptions about their drugs. Therefore,
FDA is issuing this guidance to provide recommendations for presenting
quantitative efficacy and risk information in DTC promotional
communications and to encourage firms to follow these recommendations
when including such information in their DTC promotional
communications.
The guidance covers the following topics for presenting
quantitative efficacy and risk information in DTC promotional
communications, based on current research findings related to
communicating health information:
<bullet> Providing quantitative efficacy or risk information for
the control group, when applicable;
<bullet> Presenting probability information in terms of absolute
frequencies, percentages, and relative frequencies;
<bullet> Formatting quantitative efficacy or risk information; and
<bullet> Using visual aids to illustrate quantitative efficacy or
risk information.
This guidance finalizes the draft guidance entitled ``Presenting
Quantitative Efficacy and Risk Information in Direct-to-Consumer
Promotional Labeling and Advertisements'' issued on October 17, 2018
(83 FR 52484). FDA considered comments received on the draft guidance
as the guidance was finalized. Changes from the draft to the final
guidance include clarifying considerations for quantitative efficacy or
risk presentations across various media types and providing additional
explanations regarding specific concepts and examples that were
included in the draft guidance. In addition, editorial and
organizational changes were made to improve clarity.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Presenting Quantitative Efficacy and Risk
Information in Direct-to-Consumer Promotional Labeling and
Advertisements.'' 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
This guidance document recommends information collection activity
subject to review and approval by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
Burden that may be attributable to recommendations for presenting
quantitative efficacy and risk information in direct-to-consumer
promotional labeling and advertisements as discussed in Section III of
the guidance document is approved under OMB control number 0910-0686.
The guidance document also refers to previously approved FDA
collections of information. The collections of information in 21 CFR
202.1 have been approved under OMB control number 0910-0686.
III. Electronic Access
Persons with access to the internet may obtain the guidance 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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>,
<a href="https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm">https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm</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>.
Dated: June 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13775 Filed 6-27-23; 8:45 am]
BILLING CODE 4164-01-P
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