[Federal Register Volume 68, Number 165 (Tuesday, August 26, 2003)]
[Notices]
[Page 51270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-21751]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0361]


Anti-counterfeit Drug Initiative

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
is establishing a docket to receive information and comments on the 
agency's initiative against counterfeit drugs. Many individuals, 
vendors, trade and professional associations, consumer groups, and 
other stakeholders have offered to assist FDA. This action is intended 
to ensure that there is a venue for information and comments to be 
submitted to the agency regarding the anti-counterfeit initiative.

DATES: The agency encourages interested parties to submit information 
by November 30, 2003.

ADDRESSES: Submit written comments and information 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://www.fda.gov/dockets/ecomments. All comments submitted to the 
public docket are public information and may be posted to FDA's Web 
site (http://www.fda.gov) for public viewing. Please include the docket 
number listed in the heading of this document on all correspondence 
related to this docket.

FOR FURTHER INFORMATION CONTACT: Poppy Kendall, Office of Policy (HF-
11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-3360, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Counterfeit drugs pose potentially serious public health and safety 
concerns. They may contain only inactive ingredients, incorrect 
ingredients, improper dosages, or even dangerous subpotent or 
superpotent ingredients. In the United States, drug counterfeiting is a 
relatively rare event. Although FDA believes domestic counterfeiting is 
not widespread, the agency has recently seen an increase in 
counterfeiting activities as well as a more sophisticated ability to 
introduce finished dosage counterfeits into the otherwise legitimate 
drug distribution channels. FDA has seen its counterfeit drug 
investigations increase to over 20 per year since 2000, after averaging 
only about 5 per year through the late 1990's.
    In an effort to protect against the rising occurrence of 
potentially unsafe counterfeit drugs reaching consumers, on July 16, 
2003, FDA announced an initiative to more aggressively protect American 
consumers from the risks posed by counterfeit drugs. As part of this 
effort, FDA established an internal task force that will develop 
recommendations for steps FDA, other government agencies, and the 
private sector can take to minimize the risks to the public from 
counterfeit drugs getting into the supply chain. Some of the areas that 
FDA's task force will explore include the following topics:
    [sbull] Technology: Assess the extent to which new technologies can 
help assure the authenticity of drugs;
    [sbull] Regulatory/Legislative Issues: Will evaluate potential 
regulatory and legislative changes that could be made to strengthen the 
nation's protections against counterfeiting;
    [sbull] Public Education: Recommend ways to educate consumers and 
health providers on steps they can take to minimize risks associated 
with counterfeit drugs; will also educate consumers and health 
professionals about what to look for and what to do if they suspect 
they have received a counterfeit drug;
    [sbull] Industry and Health Professional Issues: Identify actions 
industry and health professionals can take to prevent, detect, and 
respond to counterfeit drugs;
    The task force has the following deliverables:
    [sbull] Interim task force report to be released in September 2003. 
It will include draft recommendations on which interested persons may 
comment.
    [sbull] Public meeting to be held in mid-October 2003. The meeting 
announcement will be published in a forthcoming Federal Register and 
will pose issues for discussion at the meeting.
    [sbull] Final task force report to be released in January 2004.
    Many individuals, vendors, trade and professional associations, 
consumer groups, and other stakeholders have offered to assist the 
agency and provide information that may be helpful in the agency's 
anti-counterfeit drug efforts. The agency requests that all persons or 
organizations that would like to provide such information submit it to 
this docket number.
    FDA expects to place submissions it receives on this initiative in 
the public docket. Therefore, submitters should recognize that 
information submitted to this docket is public information and can be 
viewed and accessed by the general public.
    Note that, as mentioned previously, the counterfeit task force 
expects to issue a report with draft recommendations for public comment 
in September of this year. In addition, the agency expects to hold a 
public meeting on these issues later this year as well. Comments on the 
draft report and the issues discussed at the public meeting will sought 
in future issues of the Federal Register.

    Dated: August 19, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-21751 Filed 8-25-03; 8:45 am]
BILLING CODE 4160-01-S