[Federal Register Volume 80, Number 26 (Monday, February 9, 2015)]
[Notices]
[Pages 6998-7000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-02527]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-D-0500 (Formerly Docket No. 2004D-0042)]


Brief Summary and Adequate Directions for Use: Disclosing Risk 
Information in Consumer-Directed Print Advertisements and Promotional 
Labeling for Human Prescription Drugs; Revised Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revised draft guidance for industry entitled ``Brief 
Summary and Adequate Directions for Use: Disclosing Risk Information in 
Consumer-Directed Print Advertisements and Promotional Labeling for 
Human Prescription Drugs.'' This revised draft guidance, when 
finalized, will assist manufacturers, packers, and distributors (firms) 
of human prescription drugs and biologics with meeting the brief 
summary requirement for prescription drug advertising and the 
requirement that adequate directions for use be included with 
promotional labeling for prescription drugs when print materials are 
directed toward consumers. FDA is also announcing the withdrawal of the 
draft guidance for industry entitled ``Brief Summary: Disclosing Risk 
Information in Consumer-Directed Print Advertisements.''

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comments on 
this revised draft guidance before it begins work on the final version 
of the guidance, submit either electronic or written comments on the 
revised draft guidance by May 11, 2015. Submit either electronic or 
written comments on the proposed collection of information by April 10, 
2015.

ADDRESSES: Submit written requests for single copies of the revised 
draft guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, 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 revised draft guidance document.
    Submit electronic comments on the revised draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Regarding human prescription drugs: 
Julie Chronis, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD 
20993-0002, 301-796-1200. Regarding human prescription biological 
products: 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.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for 
industry entitled ``Brief Summary and Adequate Directions for Use: 
Disclosing Risk Information in Consumer-Directed Print Advertisements 
and Promotional Labeling for Human Prescription Drugs.'' This revised 
draft guidance updates prior FDA policy and describes the Agency's 
current thinking regarding the brief summary requirement for consumer-
directed print prescription drug advertisements. Specifically, the 
revised draft guidance includes recommendations for developing a 
consumer brief summary and notes that, so long as firms include 
appropriate information in a print advertisement as outlined in the 
revised draft guidance, FDA does not intend to object for a failure to 
include certain other information.
    Additionally, this revised draft guidance provides new 
recommendations regarding the adequate directions for use requirement 
for consumer-directed print promotional labeling for prescription drug 
products. Although the requirement in 21 CFR 201.100(d) for firms to 
provide adequate information for use is generally fulfilled by 
providing the full FDA-approved package insert (PI), this revised draft 
guidance provides that, in exercising its enforcement discretion, FDA 
does not intend to object for failure to include the full PI with 
consumer-directed print promotional labeling pieces if firms include 
the appropriate information as outlined in the revised draft guidance, 
i.e., the same information in the consumer brief summary. This 
recommendation is designed to standardize the information consumers 
receive in print prescription drug product advertisements and 
promotional labeling and to make information more understandable to 
consumers.
    FDA issued a draft guidance in the Federal Register of February 10, 
2004 (69 FR 6308), entitled ``Brief Summary:

[[Page 6999]]

Disclosing Risk Information in Consumer-Directed Print 
Advertisements.'' FDA requested comments on whether the draft guidance 
provided sufficient guidance on the content of the consumer brief 
summary and also requested research results on potential formats for 
the consumer brief summary. Comments, suggestions, and research were 
submitted to Docket No. 2004D-0042 and were carefully analyzed and 
considered before developing this revised draft guidance.
    This revised draft guidance incorporates information from recent 
social science research, clarifies the risk information that should be 
included in the consumer brief summary, and recommends several 
formatting options for this information. The revised draft guidance 
also recommends the use of consumer-friendly language and visual 
techniques to improve accessibility for consumers. Additionally, this 
revised draft guidance recommends that firms not disseminate the full 
PI to fulfill the requirements in Sec.  201.100(d) for consumer-
directed print promotional labeling for prescription drugs. Rather, the 
revised draft guidance recommends that firms provide the same content 
and format created for the consumer brief summary. FDA is issuing this 
revised guidance as a draft to allow for public comment on the 
recommendations.
    This revised draft guidance is being issued consistent with FDA's 
good guidance practices regulations (21 CFR 10.115). The revised draft 
guidance, when finalized, will represent FDA's current thinking on the 
brief summary and adequate directions for use requirements. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations.

II. The Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the 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. This 
revised draft guidance also refers to previously approved collection of 
information found in FDA regulations.
    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 collected; and (4) ways to 
minimize the burden of information collected on the respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Brief Summary and Adequate Directions for Use: Disclosing 
Risk Information in Consumer-Directed Print Advertisements and 
Promotional Labeling for Human Prescription Drugs.
    Description of Respondents: Respondents to this collection of 
information are manufacturers, packers, and distributors (firms) of 
prescription human drug products, including biological products.
    Burden Estimate: The revised draft guidance pertains to the brief 
summary requirement for prescription drug advertising and the 
requirement that adequate directions for use be included with 
promotional labeling for human prescription drugs when print materials 
are directed toward consumers.
    The revised draft guidance, in part, explains FDA's current policy 
position that FDA does not intend to object for failure to include the 
entire PI to fulfill the requirements of Sec.  201.100(d) for 
promotional labeling pieces directed toward consumers, if firms instead 
provide information on the most serious and the most common risks 
associated with the product, while omitting less important information. 
Specifically, FDA recommends that any Boxed Warning, all 
Contraindications, certain information regarding Warnings and 
Precautions (i.e., the most clinically significant information from the 
Warnings and Precautions section of the PI, information that would 
affect a decision to prescribe or take a drug, monitoring or laboratory 
tests that may be needed, special precautions not set forth in other 
parts of the PI, and measures that can be taken to prevent or mitigate 
harm), and the most frequently occurring Adverse Reactions should be 
included.
    Furthermore, FDA recommends that information should include the 
indication for the use being promoted. Information regarding patient 
directives (such as ``discuss with your health care provider any pre-
existing conditions'' or ``tell your health care provider if you are 
taking any medications'') should also be included. Other types of 
information may be included if relevant to the drug or specific 
indication referred to in the promotional material(s). A statement 
should be included that more comprehensive information can be obtained 
from various sources, including the firm.
    Thus, the revised draft guidance recommends that firms disclose 
certain information to others in place of the PI to fulfill the 
requirements in Sec.  201.100(d). This ``third-party disclosure'' 
constitutes a ``collection of information'' under the PRA.
    FDA estimates that approximately 400 firms disseminate 24,000 
consumer-directed print promotional labeling pieces annually. FDA 
estimates that it will take firms approximately 10 hours to compile and 
draft the information needed to provide the information recommended in 
the revised draft guidance.

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                  Number of
Adequate information for use: disclosing risk information      Number of       disclosures  per     Total annual        Hours per         Total hours
        in consumer-directed promotional labeling             respondents         respondent        disclosures         disclosure
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Disclosures Related to Adequate Information for Use (Sec.               400                 60             24,000                 10            240,000
   201.100(d))...........................................
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There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 7000]]

    This revised draft guidance also refers to previously approved 
collections of information found in FDA regulations with respect to the 
brief summary requirement. These collections of information are subject 
to review by OMB under the PRA. The collection of information in 21 CFR 
202.1 has been approved under OMB control number 0910-0686.

III. Comments

    In addition to general comments, FDA specifically requests comments 
on the following issues:
    <bullet> In the revised draft guidance, FDA provides 
recommendations regarding the content and format of the consumer brief 
summary. Is this the most useful information for consumers to use in 
determining whether to take a medication or seek more information about 
a product, and if not, what information would be more useful?
    <bullet> FDA is also interested in relevant research that has been 
conducted or alternative formats that were developed after we received 
comments on the 2004 draft guidance.
    <bullet> In the revised draft guidance, FDA suggests that the 
adequate directions for use requirement be fulfilled by providing the 
consumer brief summary rather than the full PI for the product. FDA 
seeks comments regarding this recommendation.
    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: February 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02527 Filed 2-6-15; 8:45 am]
BILLING CODE 4164-01-P