[Federal Register: January 26, 2004 (Volume 69, Number 16)]
[Page 3588-3589]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003D-0570]

Request for Comments on a Draft Guidance on the Clinical 
Evaluation of Weight-Control Drugs

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


SUMMARY:  The Food and Drug Administration (FDA) is requesting comments 
on a previously published draft guidance that has never been finalized. 
The draft guidance entitled ``Guidance for the Clinical Evaluation of 
Weight-Control Drugs'' was issued September 24, 1996. The draft 
guidance gives recommendations for the design and conduct of phase 1-3 
clinical studies aimed at demonstrating the efficacy and safety of 
weight-loss medications. The agency would like to revise this document 
for republication as a draft. Before it does this, the agency would 
like interested persons to review and submit comments on the 1996 draft 
guidance document.

DATES:  Submit written or electronic comments on the draft guidance by 
April 26, 2004. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Office of Drug Information (HFD-240), Center for Drug Evaluation 

[[Page 3589]]

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. Submit written comments on the guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT: Oluchi Elekwachi, Center for Drug 
Evaluation and Research (HFD-510), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-6381.


I. Background

    Weight-loss medications approved by FDA before the 1990s, such as 
phentermine and diethylpropion, are indicated for the short-term (a few 
weeks) treatment of obesity. The short-term indication reflects the now 
rejected belief that drug-induced weight loss will be maintained after 
the medication is stopped. In recent years, it has become clear that 
the successful treatment of obesity, with or without pharmacologic 
intervention, requires long-term, if not chronic, therapy.
    In 1995, FDAs Division of Metabolic and Endocrine Drug Products 
convened an expert advisory panel to discuss the development of weight-
loss drugs indicated for the long-term treatment of obesity. The 
discussions at this meeting formed the basis for a draft guidance 
document entitled ``Guidance for the Clinical Evaluation of Weight-
Control Drugs,'' which was made available on September 24, 1996. Two of 
the more important recommendations made in the draft guidance relate to 
the duration of the phase 3 trials and the criteria used to define 
    FDA is interested in incorporating the latest scientific advances 
in the field of obesity and drug development into an amended obesity 
guidance document. Once the draft has been revised, it will be issued 
again for comment before finalization. To that end, interested parties 
are encouraged to submit comments on the 1996 draft obesity guidance.
    This request for comments on the 1996 draft guidance is being 
issued consistent with FDAs good guidance practices (GGPs) regulation 
(21 CFR 10.115). The draft guidance, when finalized, will represent the 
agency's current thinking on this topic. It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. You can use an alternative approach if the approach satisfies 
the requirement of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the draft 
guidance. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in the brackets in the heading of this document. A copy of received 
comments are available for public examination in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www

    Dated: January 6, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-1496 Filed 1-23-04; 8:45 am]