[Federal Register Volume 88, Number 123 (Wednesday, June 28, 2023)]
[Notices]
[Pages 41966-41967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 This guidance finalizes the draft guidance of 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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, [email protected]; 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, [email protected].

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:
     Providing quantitative efficacy or risk information for 
the control group, when applicable;
     Presenting probability information in terms of absolute 
frequencies, percentages, and relative frequencies;
     Formatting quantitative efficacy or risk information; and
     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 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, 
https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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