[Federal Register Volume 62, Number 155 (Tuesday, August 12, 1997)]
[Notices]
[Pages 43171-43173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21291]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97D-0302]
Draft Guidance for Industry; Consumer-Directed Broadcast
Advertisements; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Consumer-Directed Broadcast
Advertisements.'' The draft guidance is intended to provide information
to enable product sponsors to fulfill the requirements for consumer-
directed broadcast advertisements, while providing consumers with
required risk information about the advertised products. This draft
guidance represents the agency's current thinking on consumer-directed
broadcast advertisements for prescription drugs for humans and animals,
and human biological products. The agency requests comments on this
draft guidance.
DATES: Written comments may be submitted on the draft guidance document
by October 14, 1997. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFD-305), Food and Drug Administration, 12420 Parklawn Dr., rm 1-23,
Rockville, MD 20857. Submit written requests for single copies of the
draft guidance entitled ``Consumer-Directed Broadcast Advertisements''
to the Drug Information Branch (HFD-210), Center for Drug Evaluation
and Research, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one self-addressed adhesive label to assist
that office in processing your requests.
FOR FURTHER INFORMATION CONTACT:
Regarding prescription human drugs: Nancy M. Ostrove, Division of
Drug Marketing, Advertising and Communications (HFD-40), Center for
Drug Evaluation and Research, Food and Drug Administration, 5600
Fishers Lane, rm. 17B04, Rockville, MD 20857, 301-827-2828, or via e-
mail at ostrove@cder.fda.gov.
Regarding prescription human biological products: Toni M. Stifano,
Center for Biologics Evaluation and Research (HFM-200), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
3028, or via e-mail at stifano@cber.fda.gov.
Regarding prescription animal drugs: Edward Spenser, Center for
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500
Standish Pl., Rockville, MD, 20855, 301-594-1722, or via e-mail at
espenser@bangate.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A. Statutory and Regulatory Requirements
Section 502(n) (21 U.S.C. 352(n)) of the Federal Food, Drug, and
Cosmetic
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Act (the act) requires that advertisements for prescription drugs for
humans and animals and human biological products include information in
brief summary relating to side effects, contraindications, and
effectiveness. This is known as the ``brief summary'' requirement. The
prescription drug advertising regulations in Sec. 202.1(e)(1) and
(e)(3)(iii) (21 CFR 202.1(e)(1) and (e)(3)(iii)) further require that
the brief summary disclose all the risk-related information in a
product's approved package labeling (package insert or product package
insert).
The regulations for advertising prescription drugs through
broadcast media, such as radio, television, or telephone communications
systems, however, modify the disclosure requirements somewhat. All
prescription drug broadcast advertisements must include information
about the major risks of the advertised drug (the ``major statement'')
in either the audio or audio and visual parts of the presentation.
Instead of presenting a ``brief summary'' in connection with the
broadcast advertisement, a sponsor may make adequate provision for the
dissemination of the approved package labeling in connection with the
broadcast presentation (Sec. 202.1(e)(1)). This alternative
requirement is referred to as the ``adequate provision'' requirement.
The ``adequate provision'' requirement recognizes the inability of
broadcast advertisements of reasonable length to present and
communicate effectively the extensive information that would be
included in a brief summary; it instead specifies that presentation of
the advertised product's most important risk information as part of the
``major statement,'' together with ``adequate provision'' for the
dissemination of the approved labeling, can fulfill the risk
information disclosure mandated by the act.
B. History
Although direct-to-consumer (DTC) advertising has been practiced by
the prescription drug industry since the early 1980's, it has become
increasingly popular in the 1990's. As a result, FDA has consulted
recently with industry, consumers, health care professionals, and other
interested parties regarding DTC prescription drug advertising.
In the Federal Register of August 16, 1995 (60 FR 42581), FDA
published a document explaining the background of DTC promotion, asking
for feedback on a number of DTC-related issues and questions, and
announcing a public hearing regarding DTC promotion. The hearing was
held on October 18 and 19, 1995, in Silver Spring, MD. In the Federal
Register of May 14, 1996 (61 FR 24314), FDA published a followup
document to address the erroneous belief expressed by some during the
public hearing that FDA required preclearance of DTC promotion and to
request feedback on several issues concerning DTC promotion. The notice
clarified that FDA has never required DTC promotional materials to be
precleared before use.
II. FDA's Plans Concerning Consumer-Directed Advertisements
As mentioned in section I.A of this document, the regulations
addressing prescription drug and biological product advertisements are
highly specific with regard to the kind and amount of information
required to be disclosed or disseminated in connection with
advertisements. Either a highly inclusive brief summary must be
presented or, in the case of broadcast advertisements, substitution may
be made by ensuring dissemination of approved package labeling. In
response to recent agency requests for input, many comments have
expressed concerns about the value for consumers of the complex,
detailed information in the brief summary for print advertisements and
approved package labeling for broadcast advertisements. FDA will
initiate any rulemaking necessary to address these concerns. In the
interim, FDA encourages product sponsors to provide consumers with
nonpromotional, consumer-friendly information that is consistent with
approved product labeling, in addition to the information currently
required by the regulations (package insert for broadcast
advertisements or brief summary for print advertisements). FDA suggests
that this information follow the guidelines outlined in the ``Action
Plan for the Provision of Useful Prescription Medicine Information''
coordinated by The Keystone Center, as accepted by the Secretary of the
Department of Health and Human Services in January 1996. In cases where
an advertised product has FDA-approved patient labeling, FDA encourages
its inclusion as part of full prescribing information. In cases where
the regulations require a brief summary, FDA encourages sponsors to
write the brief summary in consumer-friendly language. This applies to
consumer-directed print advertisements and broadcast advertisements
that present a brief summary.
III. Consumer-Directed Broadcast Advertisements
Previously, FDA had not described how prescription drug and
biological product sponsors could fulfill the ``adequate provision''
requirement for consumer-directed broadcast advertising. However, over
the past several years, FDA has vastly expanded its experience in
regulating DTC advertising that communicates important information and
is not false or misleading. In light of the agency's increased
experience and recent public input, FDA has reconsidered the issue of
adequate provision as it relates to consumer-directed broadcast
advertising. Therefore, FDA is publishing a draft guidance entitled,
``Consumer-Directed Broadcast Advertisements.'' It is directed to all
new drug application, abbreviated new drug application, and abbreviated
antibiotic drug application holders; biological product license
holders; and new animal drug application and abbreviated new animal
drug application holders. This draft guidance is intended to provide
consumers with adequate communication of required risk information,
while facilitating the process used by sponsors to advertise their
products to consumers. This draft guidance describes an approach that
sponsors can use to fulfill the requirement for adequate provision for
dissemination of the approved package labeling in connection with
consumer-directed broadcast advertisements for drug and biological
products, as long as the advertisement itself includes a thorough major
statement describing the product's most important risk information.
Within 2 years of publication of the final guidance, FDA intends to
evaluate the effects of the guidance, including effects on the public
health, of DTC promotion, and specifically of consumer-directed
broadcast advertising. At the end of this evaluation period, FDA will
determine whether this guidance should be withdrawn, continued, or
modified to reflect the agency's current thinking. During this period,
FDA will continue to collect information. The agency will keep the
docket open to encourage the collection and submission of additional
information from the public. FDA requests that sponsors and other
interested parties collect relevant data on the impact of DTC
promotional messages and make their findings known to the agency. FDA
specifically solicits feedback on questions such as: (1) How has DTC
promotion generally affected the public health; (2) to what
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extent are consumers taking advantage of the mechanisms for obtaining
approved package labeling in connection with broadcast advertisements;
and (3) how risk messages can best be integrated into broadcast
advertisements.
This draft guidance represents the agency's current thinking on
procedures to fulfill the requirements for the disclosure of product
information in connection with consumer-directed broadcast
advertisements for prescription human and animal drugs, and human
biological products. 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
requirement of the applicable statute, regulations, or both.
IV. Request for Comments
Interested persons may, on or before October 14, 1997 submit
written comments on the draft guidance to the Dockets Management Branch
(address above). Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. The draft guidance and received comments may be seen in the
office above between 9 a.m. and 4 p.m., Monday through Friday. An
electronic version of this draft guidance is also available on the
Internet at http://www.fda.gov/cder/guidance.htm.
Dated: August 5, 1997.
Michael A. Friedman,
Lead Deputy Commissioner for the Food and Drug Administration.
[FR Doc. 97-21291 Filed 8-8-97; 8:45 am]
BILLING CODE 4160-01-F
