[Federal Register: June 9, 2006 (Volume 71, Number 111)]
[Notices]
[Page 33466-33467]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jn06-52]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0478]
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 guidance entitled ``Marketed Unapproved Drugs--
Compliance Policy Guide.'' The guidance describes how FDA intends to
exercise its enforcement discretion with regard to drugs marketed in
the United States that do not have required FDA approval for marketing.
This document supersedes 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 agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of the 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 request. Submit written comments on the
guidance to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm.
[[Page 33467]]
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: Sakineh Walther, Center for Drug
Evaluation and Research (HFD-316), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 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 OTC
drug 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 drug monograph, have
not provided FDA with evidence demonstrating that their products are
safe and effective. Therefore, FDA has an interest in taking steps to
encourage the manufacturers of these products either to obtain the
required evidence and comply with the approval provisions of the
Federal Food, Drug, and Cosmetic Act or to remove the products from the
market. FDA wants to achieve these goals 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 come to our attention either
during inspections or through outside sources.
II. The Guidance
FDA is announcing the availability of a guidance entitled
``Marketed Unapproved Drugs--Compliance Policy Guide.'' In the Federal
Register of October 23, 2003 (62 FR 60702), FDA announced the
availability of a draft guidance of the same title and gave interested
persons an opportunity to submit comments by December 22, 2003. In
response to comments received, the agency revised the guidance to
include editorial corrections and clarification of policies, including
clarification of when and how we intend to exercise our enforcement
discretion. The revisions also clarify the discussion of
``grandfather'' status and expressly state that no part of the guidance
is a finding as to the legal status of any particular drug product.
This document supersedes section 440.100 entitled ``Marketed New
Drugs Without Approved NDAs or ANDAs'' (CPG 7132c.02) of the CPG. It
applies to any new drug required to have FDA approval for marketing,
including new drugs covered by the OTC review.
The goals of the guidance are to address the following issues: (1)
Clarify for FDA personnel and the regulated industry how the FDA
intends to exercise its enforcement discretion regarding unapproved
drugs and (2) emphasize that illegally marketed drugs must obtain FDA
approval.
The guidance reflects the agency's desire to address these issues
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 guidance explains that FDA will
continue to give priority to enforcement actions involving unapproved
drugs with potential safety risks, that lack evidence of effectiveness,
and 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. It confirms that the agency will continue longstanding
policies regarding firms making unapproved drugs who are violating the
act in other respects and clarifies how the agency plans to address
formulation changes made to evade an enforcement action.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents 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.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the 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 brackets in the
heading of this document. The 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.
IV. Electronic Access
Persons with access to the Internet may obtain the document 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
.fda.gov/ohrms/dockets/default.htm.
Dated: June 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-9032 Filed 6-8-06; 8:45 am]
BILLING CODE 4160-01-S