[Federal Register: October 23, 2003 (Volume 68, Number 205)]
[Notices]
[Page 60702-60703]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23oc03-54]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0478]
Draft Guidance on Marketed Unapproved Drugs; Compliance Policy
Guide; 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availability of a draft guidance entitled ``Marketed Unapproved Drugs;
Compliance Policy Guide.'' This draft guidance describes how FDA
intends to exercise its enforcement discretion with
[[Page 60703]]
regard to drugs marketed in the United States that do not have required
FDA approval for marketing. This document will, when finalized,
supersede section 440.100 entitled ``Marketed New Drugs Without
Approved NDAs or ANDAs'' (CPG 7132c.02) of the Compliance Policy Guide
(CPG). It applies to any new drug required to have FDA approval for
marketing, including new drugs covered by the over-the-counter (OTC)
review.
DATES: Submit written or electronic comments on the draft guidance by
December 22, 2003. 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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 (CDER), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857. Send one self addressed adhesive
label to assist the office in processing your requests. Submit written
comments on the draft guidance to the Division of Dockets Management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electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Sakineh Walther, Center for Drug
Evaluation and Research (HFD-316), Food and Drug Administration, 1451
Rockville Pike, Rockville, MD 20852, 301-827-8964.
SUPPLEMENTARY INFORMATION:
I. Background
In the United States, as many as several thousand drug products are
marketed illegally without required FDA approval. The manufacturers of
these drugs have neither received FDA approval to legally market their
drugs, nor have the drugs been marketed in accordance with a final
over-the-counter (OTC) monograph. The drug approval and OTC monograph
processes play an essential role in ensuring that all drugs are both
safe and effective. Manufacturers of new drugs that lack required
approval, including those that are not marketed in accordance with an
OTC monograph, have not provided FDA with evidence demonstrating that
their products are safe and effective. Therefore, FDA has an interest
in taking steps to either encourage the manufacturers of these products
to obtain the required evidence and comply with the approval provisions
of the Federal Food, Drug, and Cosmetic Act (the act), or to remove the
products from the market. FDA recognizes that these goals need to be
achieved without adversely affecting public health, imposing undue
burdens on consumers, or unnecessarily disrupting the market.
In general, in recent years, FDA has employed a risk-based
enforcement approach to marketed unapproved drugs that includes efforts
to identify illegally marketed drugs, prioritization of those drugs
according to potential public health concerns or other impacts on the
public health, and subsequent regulatory followup. Some of the specific
actions the agency has taken have been precipitated by evidence of
safety or effectiveness problems that has either come to our attention
during inspections or was brought to our attention by outside sources.
The goals of this draft guidance are to address the following
issues: (1) Clarify for FDA personnel and the regulated industry how
FDA intends to exercise its enforcement discretion regarding unapproved
drugs and (2) emphasize that illegally marketed drugs must obtain FDA
approval.
The draft guidance reflects the agency's desire to address this
issue with policies that are predictable, reasonable, and supportive of
the public health. The agency's approach encourages companies to comply
with the drug approval process, but it also seeks to minimize
disruption to the marketplace and to safeguard consumer health when
there are potential safety risks. The draft guidance explains that FDA
will continue to give priority to enforcement actions involving
unapproved drugs: (1) with potential safety risks, (2) that lack
evidence of effectiveness, and (3) that constitute health fraud. It
also explains how the agency intends to address those situations in
which a firm obtains FDA approval to sell a drug that other firms have
long been selling without FDA approval.
This draft guidance is being issued consistent with FDA's good
guidance practices 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. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
Two copies of mailed 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 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 can obtain the guidance at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm.
Dated: October 15, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-26753 Filed 10-20-03; 3:00 pm]
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