[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Labeling for Human Prescription Drugs; Revised Draft Guidance for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availability of a revised draft guidance for industry entitled ``Brief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 This revised draft guidance, when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draft guidance for industry entitled ``Brief Summary: Disclosing Risk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this revised draft guidance before it begins work on the final version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revised draft guidance by May 11, 2015.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draft guidance to the Division of Drug Information, Center for Drug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:
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?
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.
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