[Federal Register Volume 80, Number 151 (Thursday, August 6, 2015)]
[Notices]
[Pages 46990-46993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19244]


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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Labeling for Prescription Drugs; Revised Draft Guidance for Industry 
(Revision 2); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
reissuance of a revised draft guidance for industry (Revision 2) 
entitled ``Brief Summary and Adequate Directions for Use: Disclosing 
Risk Information in Consumer-Directed Print Advertisements and 
Promotional Labeling for Prescription Drugs.'' We are reissuing the 
revised draft guidance to incorporate animal prescription drugs. This 
reissued revised draft guidance, when finalized, will assist 
manufacturers, packers, and distributors (firms) of human prescription 
drugs, including biologics, and animal prescription drugs, 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.

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this reissued revised draft guidance before it

[[Page 46991]]

begins work on the final version of the guidance, submit either 
electronic or written comments on the reissued revised draft guidance 
by October 5, 2015. Submit either electronic or written comments on the 
proposed collection of information by October 5, 2015.

ADDRESSES: Submit written requests for single copies of the reissued 
revised draft guidance to the Division of Drug Information, Center for 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; 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; or to 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 revised draft guidance 
document.
    Submit electronic comments on the reissued 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. Regarding animal 
prescription drugs: Thomas Moskal, Center for Veterinary Medicine, Food 
and Drug Administration, 7519 Standish Pl. Rockville, MD 20855-2792, 
240-402-6251.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the reissuance 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 Prescription Drugs.'' We are reissuing the 
revised draft guidance to incorporate animal prescription drugs; there 
are no other revisions to the revised draft guidance for industry 
issued February 9, 2015 (80 FR 6998).
    As stated previously, the 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, the 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) and 21 CFR 
201.105(d) for firms to provide adequate information for use is 
generally fulfilled by providing the full FDA-approved package insert 
(PI), the 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: 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 the revised 
draft guidance.
    FDA issued the revised draft guidance in the Federal Register of 
February 9, 2015, giving interested parties an opportunity to submit 
comments by May 11, 2015. We are reissuing the revised draft guidance 
to incorporate animal prescription drugs; there are no other revisions 
to the revised draft guidance issued February 2015.
    The 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, the 
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 the 
revised guidance as a draft to allow for public comment on the 
recommendations.
    The reissued revised draft guidance is being issued consistent with 
FDA's good guidance practices regulations (21 CFR 10.115). The reissued 
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. The 
revised draft guidance also refers to previously approved collection of 
information found in FDA regulations.

[[Page 46992]]

    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 Prescription Drugs.
    Description of Respondents: Respondents to this collection of 
information are manufacturers, packers, and distributors (firms) of 
human and animal prescription drug products, including biological 
products for use in humans.
    Burden Estimate: The reissued 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 and animal prescription drugs when print 
materials are directed toward consumers.
    The reissued 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. Sec.  
201.100(d) and 201.105(d)(1) 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 reissued revised draft guidance recommends that firms 
disclose certain information to others in place of the PI to fulfill 
the requirements in Sec. Sec.  201.100(d) and 201.105(d). This ``third-
party disclosure'' constitutes a ``collection of information'' under 
the PRA.
    FDA estimates that approximately 400 firms subject to Sec.  
201.100(d) disseminate 24,000 consumer-directed print promotional 
labeling pieces annually. FDA estimates that approximately 40 firms 
subject to Sec.  201.105(d) disseminate 2,000 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. Please note that the requirements related to print 
advertising pieces and the associated burden is already accounted for 
under the requirements under 21 CFR 202.1 and its approved information 
collection OMB control number 0910-0686 and, therefore, is not included 
in the burden estimate reported in table 1.

                                 Table 1--Estimated Annual Reporting Burden \1\
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  Adequate information for use:
 Disclosing risk information in      Number of       Number of     Total annual      Hours per
  consumer-directed promotional     respondents     disclosures     disclosures     disclosure      Total hours
            labeling                              per respondent
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Disclosures Related to Adequate              400              60          24,000              10         240,000
 Information for Use (Sec.
 201.100(d))....................
Disclosures Related to Adequate               40              50           2,000              10          20,000
 Information for Use (Sec.
 201.105(d))....................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    This reissued revised draft guidance also refers to previously 
approved collections of information found in FDA regulations with 
respect to the brief summary requirement for print advertisements. 
These collections of information are subject to review by OMB under the 
PRA. The collection of information in Sec.  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.
    Persons who commented on the version of the revised draft guidance 
issued in February 2015 do not need to resubmit their comments. When 
finalizing the revised draft guidance, we will review comments received 
on this reissued version, as well as the version issued February 2015.
    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

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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, http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or http://www.regulations.gov.

    Dated: July 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19244 Filed 8-5-15; 8:45 am]
BILLING CODE 4164-01-P