Draft Guidance for Industry; Consumer-Directed Broadcast Advertisements; Availability

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Draft Guidance for Industry; Consumer-Directed Broadcast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availability of a draft guidance entitled ``Consumer-Directed Broadcast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 The draft guidance is intended to provide information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draft guidance.

DATES: Written comments may be submitted on the draft guidance document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draft guidance entitled ``Consumer-Directed Broadcast Advertisements''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

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