[Federal Register Volume 69, Number 27 (Tuesday, February 10, 2004)]
[Notices]
[Pages 6308-6309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-2728]



[[Page 6308]]

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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.

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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withdrawal of the draft guidance for industry entitled ``Using FDA-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electronic access to the draft guidance document.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 consumer-
directed 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 consumer-directed 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

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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 FDA-approved 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 ``help-
seeking'' 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 so-called ``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 Sec.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 consumer-directed 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