6308 Federal Register / Vol. 69, No. 27 / Tuesday, February 10, 2004 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0042]

Draft Guidances for Industry on 

Improving Information About Medical 

Products and Health Conditions; 

Withdrawal; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of three draft guidances for 

industry designed to improve 

information provided to consumers and 

health care practitioners by medical 

product firms about medical products 

and health conditions. The three 

guidances are entitled: ‘‘Brief Summary: 

Disclosing Risk Information in 

Consumer-Directed Print 

Advertisements’’ (Brief Summary 

Guidance), ‘‘Help-Seeking and Other 

Disease Awareness Communications by 

or on Behalf of Drug and Device Firms’’

(Disease Awareness Guidance), and 

‘‘Consumer-Directed Broadcast 

Advertising of Restricted Devices ’’

(Device Broadcast Advertising 

Guidance). FDA is also announcing the 

withdrawal of the draft guidance for 

industry entitled ‘‘Using FDA-Approved 

Patient Labeling in Consumer-Directed 

Print Advertisements.’’

DATES: Written comments on the draft 

guidances may be submitted by May 10, 

2004. General comments on agency 

guidance documents are welcome at any 

time.

ADDRESSES: Submit written requests for 

single copies of the draft guidances to 

the Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857; or to the Office of 

Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

Submit written comments on the draft 

guidances to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document.

FOR FURTHER INFORMATION CONTACT:

Regarding prescription human drugs: 

Lesley R. Frank, Center for Drug 

Evaluation and Research (HFD–42), 

Food and Drug Administration, 

5600 Fishers Lane, Rockville, MD 

20857, 301–827–2831.

Regarding prescription human 

biological products: Glenn N. Byrd, 

Center for Biologics Evaluation and 

Research (HFM–600), Food and 

Drug Administration, 1401 

Rockville Pike, Rockville, MD 

20852–1448, 301–827–3028.

Regarding medical device products: 

Deborah Wolf, Center for Devices 

and Radiological Health (HFZ–300), 

2098 Gaither Road, Rockville, MD 

20850, 301–594–4589.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

three draft guidances designed to 

improve information provided to 

consumers and health care practitioners 

by medical product firms about medical 

products and health conditions. The 

guidances were prepared in part based 

on discussions and presentations at an 

open public meeting on consumerdirected advertising that FDA held in 

September 2003, http://www.fda.gov/

cder/ddmac/DTCmeeting2003.html. The 

three guidances are entitled ‘‘Brief 

Summary: Disclosing Risk Information 

in Consumer-Directed Print 

Advertisements’’ (Brief Summary 

Guidance), ‘‘Help-Seeking and Other 

Disease Awareness Communications by 

or on Behalf of Drug and Device Firms’’

(Disease Awareness Guidance), and 

‘‘Consumer-Directed Broadcast 

Advertising of Restricted Devices ’’

(Device Broadcast Advertising 

Guidance). The draft guidances are 

intended to provide clear advice to 

medical product firms on the rules 

applicable to certain communications to 

consumers and health care practitioners.

One of the principal objectives of the 

three guidances is to encourage 

prescription drug firms to present risk 

information in their consumer-directed 

advertisements using language that is 

understandable by a lay user. Another 

purpose of the guidances is to encourage 

drug and medical device firms to 

disseminate truthful, nonmisleading, 

scientifically accurate information on 

medical products and health conditions 

to consumers and health care 

practitioners. The agency believes that, 

given clear guidelines, firms will be 

more likely to provide such information, 

and that this increased information flow 

will encourage consumers to seek, and 

health care practitioners to provide, 

appropriate diagnosis and treatment, 

particularly of under-diagnosed and 

under-treated conditions. The guidances 

are discussed in more detail in section 

II of this document.

This notice is also announcing the 

withdrawal of the draft guidance for 

industry entitled ‘‘Using FDA-Approved 

Patient Labeling in Consumer-Directed 

Print Advertisements,’’ which was 

issued by FDA on April 23, 2001 (66 FR 

20468), and which is being superseded 

by the Brief Summary Guidance.

II. The Draft Guidances

A. The Brief Summary Guidance

FDA has responsibility under the 

Federal Food, Drug, and Cosmetic Act 

(the act) for regulating advertising for 

prescription drugs. Section 502(n) of the 

act (21 U.S.C. 352(n)), requires that an 

advertisement for a prescription drug 

contain information about the risks of 

using the advertised product. This 

requirement is further defined in the 

prescription drug advertising 

regulations in part 202 (21 CFR part 

202), and is known as the ‘‘brief 

summary’’ requirement. Currently, it is 

commonplace for manufacturers to 

comply with the brief summary 

requirement by presenting verbatim and 

in small type the entire risk-related 

sections of the FDA-approved 

professional labeling.

The agency believes that a print 

advertisement that discloses the most 

serious and the most common risks of 

a product is a better way of 

communicating risk information to 

patients than the current lengthy and 

technical brief summary. Accordingly, 

the Brief Summary Guidance describes 

how sponsors can use FDA-approved 

patient labeling or Highlights of the 

FDA-approved professional labeling to 

provide risk information in consumerdirected print advertisements for 

prescription drugs.

The guidance also encourages the use 

of consumer-friendly language in 

advertisements that use highlights of 

FDA-approved professional labeling (or, 

before the proposed rule revising the 

format and content requirements of 

professional labeling become effective, 

the risk information that would appear 

in Highlights) to present risk 

information. At the same time, FDA is 

making clear that it remains permissible 

under section 502(n) of the act to 

present the entire risk-related sections 

of FDA-approved professional labeling 

verbatim in a consumer-directed print 

advertisement for prescription drugs.

B. The Disease Awareness Guidance

FDA has authority under the act to 

regulate the ‘‘labeling’’ and 

‘‘advertising’’ of prescription drugs and 

Federal Register / Vol. 69, No. 27 / Tuesday, February 10, 2004 / Notices 6309

restricted devices. Ordinarily, these 

categories include promotional 

messages disseminated by or on behalf 

of a drug or device firm recommending 

use of a drug or device or containing 

some claim of safety or effectiveness for 

a drug or device. One of the principal 

requirements for labeling and 

advertising is the disclosure of risk 

information (either the full FDAapproved professional labeling or the 

brief summary). The labeling and 

advertising rules do not apply to certain 

other forms of communication by or on 

behalf of drug and device firms. One of 

these categories is disease awareness 

communications.

The Disease Awareness Guidance is 

intended to eliminate any confusion as 

to what principles FDA will apply in 

determining whether communications 

by or on behalf of drug and device firms 

qualify as ‘‘labeling’’or ‘‘advertising,’’ or 

as disease awareness communications. 

FDA believes that firms are already 

engaged in a substantial amount of 

disease awareness communication 

aimed at consumers (so-called ‘‘helpseeking’’ communications). 

Manufacturers may, however, be less 

familiar with disease awareness 

communications directed at health care 

professionals. Accordingly, this draft 

guidance contains examples of materials 

currently distributed to health care 

practitioners by government entities and 

educational organizations about health 

conditions to help demonstrate to drug 

and device firms the kinds of disease 

awareness materials they might also 

disseminate. FDA believes that this will 

encourage firms to distribute disease 

awareness information not only to 

patients, but also to health care 

practitioners, thereby encouraging more 

widespread diagnosis and treatment of 

under-diagnosed and under-treated 

health conditions.

The draft guidance also addresses the 

important issue of when disease 

awareness communications become 

subject to FDA regulation as ‘‘labeling’’

or ‘‘advertising’’ by virtue of their 

presentation in combination with socalled ‘‘reminder’’ advertisements or 

labeling or product-claim 

advertisements or labeling.

C. The Device Broadcast Advertising 

Guidance

In 1999, FDA issued final guidance to 

industry on a manner in which 

consumer-directed broadcast 

advertisements for prescription drugs 

could satisfy statutory and regulatory 

requirements for the presentation of risk 

information. The Device Broadcast 

Advertising Guidance adopts the same 

approach for restricted devices, with 

minor revisions recognizing the 

differences in statutory provisions 

relating to prescription drugs and 

restricted devices.

III. Good Guidance Practices

These draft guidances are being 

issued consistent with FDA’s good 

guidance practices (GGPs) regulations 

(21 CFR 10.115). They represent the 

agency’s current thinking on certain 

issues relating to certain types of 

communications about medical 

products and health conditions. They 

do not create or confer any rights for or 

on any person and do not operate to 

bind FDA or the public. Alternative 

approaches may be used if such 

approaches satisfy the requirements of 

the applicable statutes and regulations.

IV. Comments

FDA specifically requests comments 

on the following issues:

1. The Device Broadcast Advertising 

Guidance, like its CDER counterpart 

issued in 1999, does not address the 

meaning of ‘‘major statement’’ in 

§202.1(e)(1) (21 CFR 202.1(e)(1)). 

Should FDA issue guidance on this 

issue? If the agency should, what should 

the guidance provide?

2. The Brief Summary Guidance 

contemplates that firms will disclose 

risk information in their consumerdirected print advertisements for 

prescription drugs in ways that focus on 

the most serious and the most common 

risks, and explains that this includes all 

warnings, all contraindications, and 

certain precautions and adverse events. 

Does the draft guidance provide 

sufficiently concrete advice on this 

point? If it does not, how should the 

guidance be revised?

In the guidance documents 

themselves, FDA requests comments on 

the following issues:

1. In the Brief Summary Guidance, 

FDA requests comments, suggestions, or 

results of research to help the agency 

assess ways in which risk information 

can be presented to consumers (e.g., in 

a text box with accompanying brief 

summary-type disclosure, or in the main 

body of the advertisement without such 

accompanying disclosure).

2. In the Disease Awareness 

Guidance, FDA requests comments on 

whether data exist that help establish 

specific criteria for defining ‘‘close 

physical or temporal proximity’’ to use 

in evaluating whether bookend-type 

communications are within FDA’s 

‘‘labeling’’ or ‘‘advertising’’ authority 

under the act.

Interested persons may submit written 

or electronic comments on the draft 

guidances to the Division of Dockets 

Management (see ADDRESSES). 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. Comments should identify 

clearly which guidance they are 

commenting on. The draft guidances 

and received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

V. Electronic Access

Persons with access to the Internet 

may obtain the documents at http://

www.fda.gov/cder/guidance/index.htm, 

http://www.fda.gov/cber/guidelines, or 

http://www.fda.gov/ohrms/dockets/

default.htm.

Dated: February 4, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–2728 Filed 2–5–04; 9:36 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0277]

Draft Guidance for Industry on Time 

and Extent Applications; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Time and Extent 

Applications.’’ This guidance is being 

written to assist those persons interested 

in adding a new condition to the overthe-counter (OTC) drug monograph 

system. A time and extent application 

(TEA) can be submitted for FDA to 

determine whether a condition is 

eligible to be considered for inclusion in 

an OTC drug monograph. This guidance 

is designed to clarify issues concerning 

the TEA in an effort to facilitate the 

application process.

DATES: Submit written or electronic 

comments on the draft guidance by 

April 12, 2004. General comments on 

agency guidance documents are 

welcome at any time.

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane,