[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Draft Guidance for Industry; Consumer-Directed Broadcast 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availability of a draft guidance entitled ``Consumer-Directed Broadcast 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 The draft guidance is intended to provide information 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 This draft 
guidance represents the agency's current thinking on consumer-directed 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draft guidance.

DATES: Written comments may be submitted on the draft guidance document 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draft guidance entitled ``Consumer-Directed Broadcast Advertisements'' 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 [email protected].
    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 [email protected].
     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 
[email protected].

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