[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Pages 52484-52487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22568]


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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to-Consumer Promotional Labeling and Advertisements; Draft Guidance for 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the availability of a draft guidance for industry entitled ``Presenting 
Quantitative Efficacy and Risk Information in Direct-to-Consumer 
Promotional Labeling and Advertisements.'' This draft guidance provides 
recommendations for presenting quantitative efficacy and risk 
information in direct-to-consumer (DTC) promotional labeling and 
advertisements for prescription human drugs and biological products and 
prescription animal drugs and in DTC promotional labeling for over-the-
counter (OTC) animal drugs (collectively promotional materials). FDA is 
issuing this draft guidance to describe the Agency's recommendations 
for how manufacturers, distributers, and packers (collectively firms) 
that include quantitative efficacy or risk information about their 
drugs in DTC promotional materials can make the language and 
presentation more consumer-friendly.

[[Page 52485]]


DATES: Submit either electronic or written comments on the draft 
guidance by December 17, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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 Promotional Labeling and 
Advertisements; Draft Guidance for Industry; Availability.'' 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.
     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.gpo.gov/fdsys/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.
    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 draft 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; or 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; or 
the Policy and Regulations Staff (HFV-6), Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855. Send one self-addressed adhesive label to assist that office 
in processing your request. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Pepinsky, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3248, Silver Spring, MD 20993-0002, 301-
796-1200; or Stephen Ripley, 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 Tom 
Moskal, Center for Veterinary Medicine (HFV-216), 7519 Standish Pl., 
Rockville, MD 20855, 240-402-6251.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Presenting Quantitative Efficacy and Risk Information in 
Direct-to-Consumer Promotional Labeling and Advertisements.'' This 
draft guidance describes recommendations for how firms that include 
quantitative efficacy or risk information about their drugs \1\ in DTC 
promotional materials can make the language and presentation more 
consumer-friendly. These recommendations apply to DTC promotional 
materials covered by this draft guidance regardless of the medium in 
which they are presented (e.g., print, electronic, audiovisual, 
broadcast).
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    \1\ The term drugs in this guidance refers to prescription human 
drugs, including prescription biological products, and prescription 
and OTC animal drugs.
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    When describing efficacy and risk information about a drug in 
promotional materials, firms generally have flexibility with how they 
present this information so long as the presentation is balanced, 
truthful, and non-misleading, and complies with other applicable 
statutory and regulatory requirements. One consideration for firms as 
they develop DTC promotional materials for their drugs is how to best 
convey efficacy and risk information in a manner that consumers can 
easily understand, including whether to use words, numbers, visual 
graphics, or a combination of these elements. FDA understands that 
firms may experience challenges in determining how to best present 
quantitative efficacy or risk information in their DTC promotional 
materials so that consumers can easily comprehend it and use it to form 
accurate perceptions about their drugs. For these reasons, FDA is 
issuing this

[[Page 52486]]

draft guidance to provide recommendations for presenting quantitative 
efficacy and risk information in DTC promotional materials and to 
encourage firms to follow these recommendations when including such 
information in their DTC promotional materials.
    The draft guidance covers the following topics for presenting 
quantitative efficacy and risk information in DTC promotional 
materials, based on current research findings related to communicating 
health information:

 Presenting probability information in terms of absolute 
frequencies, percentages, and relative frequencies
 Formatting quantitative efficacy or risk information
 Using visual aids to illustrate quantitative efficacy or risk 
information
 Providing quantitative efficacy or risk information for the 
treatment group and the control group

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent FDA's recommendations for ``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. This guidance is not subject to 
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Presenting Quantitative Efficacy and Risk Information in 
Direct-to-Consumer Promotional Labeling and Advertisements.
    Description of Respondents: Respondents to this collection of 
information are manufacturers, packers, and distributors and their 
representatives (firms) of human prescription drugs, including 
prescription biological products, and animal prescription and OTC 
drugs.
    Burden Estimate: The draft guidance provides recommendations on how 
firms should present quantitative efficacy and risk information in 
their DTC promotional materials. Accordingly, the draft guidance 
recommends a ``third-party disclosure'' that constitutes a ``collection 
of information'' under the PRA.
    Specifically, the draft guidance recommends that firms display 
quantitative efficacy or risk information in specific numeric formats 
(e.g., absolute frequencies or percentages; whole numbers; denominators 
with a base of 10) and with appropriate context (e.g., adding absolute 
frequency presentations to relative frequency presentations); provides 
formatting considerations for illustrating quantitative efficacy or 
risk information in a visual aid; and recommends that firms include 
quantitative efficacy or risk information about the control group when 
it is provided for the treatment group in DTC promotional materials.
    According to FDA data, approximately 40,000 FDA-regulated DTC 
promotional materials are prepared by approximately 404 firms annually, 
and of these materials, the Agency estimates that approximately 40 
percent contain presentations of quantitative efficacy or risk 
information. Based on this information, FDA estimates that 
approximately 40 percent (160) firms will disseminate 16,000 DTC 
promotional materials that contain quantitative efficacy or risk 
information annually, and therefore may be subject to the third-party 
disclosures. Based on its experience reviewing FDA-regulated 
promotional materials for drugs, FDA estimates that it will take firms 
approximately 2 hours to make the disclosures recommended in the draft 
guidance if they choose to include quantitative efficacy or risk 
information in their DTC promotional materials and follow the 
recommendations of this guidance.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                        Type of information                             Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
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Recommended information to be included when firms disseminate                   160              100           16,000                2           32,000
 promotional materials that contain quantitative efficacy or risk
 information.......................................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or https://www.regulations.gov.


[[Page 52487]]


    Dated: October 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22568 Filed 10-16-18; 8:45 am]
 BILLING CODE 4164-01-P


