[Federal Register: February 10, 2004 (Volume 69, Number 27)]
[Notices]
[Page 6308-6309]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10fe04-108]
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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withdrawal of the draft guidance for industry entitled ``Using FDA-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electronic access to the draft guidance document.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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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
[[Page 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 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines, or http://www.fda.gov/ohrms/dockets/default.htm.
ult.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