[Federal Register Volume 68, Number 172 (Friday, September 5, 2003)]
[Notices]
[Pages 52772-52775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22789]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. 2003N-0361]


Anti-Counterfeit Drug Initiative; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting on the agency's effort to combat counterfeit drugs. The purpose 
of the meeting is to enable interested individuals, organizations, and 
other stakeholders to present information on all aspects of the 
agency's initiative against counterfeit drugs. FDA is particularly 
interested in hearing about information related to technology, public 
education, regulatory and legislative issues, and industry and health 
professional issues. The agency is also inviting vendors of anti-
counterfeit technologies relevant to the pharmaceutical industry to 
display their

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products for the educational benefit of FDA and attendees. The 
objective of the meeting is for FDA to gather information to assist 
FDA's counterfeit drug task force in finalizing its report, which will 
include recommendations on steps that FDA, other government agencies, 
and the private sector can take to minimize the risks to the public 
from counterfeit drugs entering the supply chain.

DATES AND TIME: The public meeting and vendor display will be held on 
October 15, 2003, from 9 a.m. to 5 p.m. Attendees should send notice of 
intent to attend the meeting by October 9, 2003. Speakers must register 
and submit a short summary of the presentation by September 24, 2003. 
Presenters must send final electronic presentations in Microsoft 
PowerPoint, Microsoft Word, or Adobe Portable Document Format (PDF) to 
FDA by close of business on October 3, 2003.
    However, written and electronic comments will be accepted for 
consideration until November 3, 2003. Vendors must register and submit 
a brief summary of the product(s) they plan to display by close of 
business September 24, 2003.

ADDRESSES: The public meeting and vendor display will be held at the 
Four Points Sheraton Bethesda, 8400 Wisconsin Ave., Bethesda, MD 20814, 
301-654-1000. The hotel may be reached by Metro using the Medical 
Center Station on the red line, which is 2 1/2 blocks from the hotel; 
or you may call the hotel for shuttle bus service. Notice of intent to 
attend the meeting and requests to present at the meeting should be 
sent to Elizabeth French, Office of Policy (HF-11), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360, 
FAX 301-594-6777, e-mail: [email protected]. Requests for vendor 
display at the meeting should be sent to Karen Strambler, Office of 
Policy (HF-11), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-3360, FAX 301-594-6777, e-mail: 
[email protected].
    Registration and Requests for Presentation: If you wish to attend 
the meeting, please notify Elizabeth French (see ADDRESSES). If you 
wish to present at the public meeting, please submit your request and a 
summary of your presentation to Elizabeth French at FDA (see 
ADDRESSES). Requests should be identified with the docket number listed 
in the heading of this document.
    Requests to present should contain the following items:
    [sbull] Presenter's name;
    [sbull] Address;
    [sbull] Telephone number;
    [sbull] E-mail address;
    [sbull] Affiliation, if any;
    [sbull] Summary of the presentation; and
    [sbull] Approximate amount of time requested for the presentation.
    FDA encourages persons and groups having similar interests to 
consolidate their information and present it through a single 
representative, if possible, to enable a broad range of views to be 
presented. After reviewing the requests to present, the agency intends 
to schedule each appearance and notify each participant by e-mail or 
telephone of the time allotted to the person and the approximate time 
the person's presentation is scheduled to begin.
    Presenters must send final electronic presentations in Microsoft 
PowerPoint, Microsoft Word, or PDF to FDA by close of business on 
October 3, 2003.
    Registration and Request for Vendors Displays:
    In addition, there will be an opportunity for vendors of 
authentication and track and trace anti-counterfeiting technologies to 
display their products in a room adjacent to the public meeting. The 
purpose of these displays is to educate FDA and other attendees of the 
types of anti-counterfeit technologies that are currently available. 
FDA is particularly interested in vendors displaying products that have 
the following features:
    [sbull] Product is currently in commercial use or production;
    [sbull] Product (or closely similar product) is currently being 
used in the pharmaceutical distribution system or that has clear 
applicability to authenticating or tracking pharmaceuticals (e.g., are 
easily incorporated into the manufacturing process, packaging, and/or 
labeling of drugs and biologics);
    [sbull] Track/trace products that have the ability to locate the 
product throughout the distribution chain from the time of manufacture 
to the time sale to a consumer;
    [sbull] Track/trace products that have the ability to be read and 
used by each entity (or individual) having physical contact with the 
pharmaceutical;
    [sbull] Covert authentication technologies that are identifiable by 
one or more points in the distribution chain (i.e. by wholesalers, 
repackers, retailers, and health care entities); and
    [sbull] Covert forensic technologies that are identifiable by a 
sophisticated analytical laboratory and the manufacturer.
    FDA is not interested in having technologies displayed that are not 
in production or current commercial use, and that are not applicable to 
pharmaceuticals. For example, technologies that are not easily 
incorporated into the manufacture, packaging, and/or labeling of 
pharmaceuticals may not be appropriate for display. Vendors should take 
these factors into account prior to determining which products to 
display.
    Because of limited space availability, all vendor requests may not 
be accommodated. If you wish to have a display at the public meeting, 
please submit your request and the following information to Karen 
Strambler (see ADDRESSES). Requests should be identified with the 
docket number listed in the heading of this document. Space available 
for display will be determined based on the number of registrants and 
total space available; however, the agency anticipates that of those 
that can be accommodated, vendors will each be provided with, at a 
minimum, a 4- by 3-foot table for table top display.
    Requests to display should contain the following items:
    [sbull] Presenter's name,
    [sbull] Address,
    [sbull] Telephone number,
    [sbull] Affiliation,
    [sbull] Product(s) for display, and
    [sbull] Brief summary of how the anti-counterfeit technology meets 
the criteria listed in the previous list items.
    After reviewing the requests to display, FDA intends to notify each 
vendor by e-mail or telephone whether there is space available for 
display.
    For Information Regarding This Notice: Poppy Kendall, Office of 
Policy (HF-11), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-9278, FAX 301-594-6777, e-mail: 
[email protected].
    If you need special accommodations due to disability, please inform 
Elizabeth French (see ADDRESSES).

SUPPLEMENTARY INFORMATION:

I. Background

    Counterfeit drugs pose potentially serious public health and safety 
concerns. They may contain only inactive ingredients, incorrect 
ingredients, improper dosages, dangerous subpotent or superpotent 
ingredients, or even adventitious agents or contaminants such as 
harmful bacteria. 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. During the late 1990's, FDA counterfeit 
drug investigations averaged about five per year. Since 2000,

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however, FDA counterfeit drug investigations have increased to an 
average of over 20 per year.
    On July 16, 2003, FDA announced an initiative to more aggressively 
protect American consumers from the risks associated with counterfeit 
drugs and reduce the possibility of potentially unsafe counterfeit 
drugs reaching consumers. As part of this effort, FDA established an 
internal task force that will develop recommendations for steps that 
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 is exploring 
are included in the following topics:
    [sbull] Technology: Assess the extent to which currently available 
and potential technologies can help assure the authenticity of drugs;
    [sbull] Regulatory/Legislative Issues: Evaluate potential State and 
Federal regulatory and legislative changes that could be made to 
strengthen the nation's protections against counterfeiting;
    [sbull] Public Education: Evaluate ways to educate consumers and 
health providers on steps they can take to minimize risks associated 
with counterfeit drugs as well as what to look for and 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 anticipates the following deliverables:
    [sbull] Interim task force report to be released in September 2003. 
We intend to include preliminary findings on which all interested 
parties may comment;
    [sbull] Final task force report to be released in January 2004. We 
intend to provide recommendations for public and private sector actions 
to address the problem of counterfeit drugs.

II. Scope of Discussion

    FDA is planning this public meeting in order to hear public 
comments on ways to combat counterfeit drugs. The objective of the 
meeting is for FDA to gather information to assist FDA's counterfeit 
drug task force in finalizing its report, which will include 
recommendations on steps that FDA, other government agencies, and the 
private sector can take to minimize the risks to the public from 
counterfeit drugs entering the supply chain. We anticipate that 
discussions at this meeting will include presentations from members of 
the public.
    FDA plans to include with the task force interim report a series of 
questions specifically addressing the preliminary findings. The 
questions will be posted on FDA's Web site at www.fda.gov. We request 
that presenters address these questions at the public meeting as well 
as the topics of interest listed in the following paragraphs. Specific 
topics of interest include, but are not limited to the following 
topics:

A. Technology

    1. What anti-counterfeit technologies currently are available for 
use as anti-counterfeit measures for pharmaceuticals (e.g., track/
trace, authentication)? What are the costs associated with these 
technologies?
    2. What is the current status of, and barriers to, adopting an 
industry standard for use of anti-counterfeiting technology?
    3. What role should FDA play in facilitating the use of anti-
counterfeit technologies and in the creation of an industry standard 
for use of anti-counterfeiting measures?
    4. Should anti-counterfeiting measures be used for all drugs and 
biologics or just for drugs at high risk for counterfeiting? Is there a 
way to identify drugs at high risk for counterfeiting?

B. Regulatory and Legislative Issues

    1. In 2001, FDA submitted a report to Congress (http://www.fda.gov/oc/pdma/report2001/default.htm) on the status of the implementation and 
enforcement of the Prescription Drug Marketing Act (PDMA). As explained 
in this report, we raised concerns regarding implementation of the 
wholesale distribution provisions at 21 CFR 203.50, and these 
provisions have been stayed until April 2004. Have circumstances 
changed since the issuance of the report to Congress that could affect 
FDA's decision to continue the stay or implement these provisions?
    2. How could PDMA be strengthened or augmented to reduce the risk 
of counterfeit drugs and biologicals from reaching consumers?
    3. If PDMA were amended by Congress to require wholesale 
distributors to prepare and pass on a pedigree to all customers 
(``universal pedigree''), including to retail pharmacies, would the 
risk of distribution of counterfeit, expired, or otherwise unsuitable 
drugs to consumers be decreased?
    4. How could state pharmacy practice acts be augmented or 
strengthened to minimize the introduction of counterfeit drugs into the 
drug distribution chain? Please give specific suggestions.

C. Public Education

    1. What are the information needs of consumers, trade groups, the 
media, state governments, manufacturers, wholesalers, pharmacists, and 
other health care professionals to help identify and report suspected 
counterfeit drugs?
    2. What is the most effective and efficient way for FDA to notify 
the public and health professionals that a counterfeit product has been 
identified? What are the emergency messages that FDA should deliver to 
its various audiences when a report of a suspected counterfeit drug is 
received by the agency?
    3. What types of communication tools are already in existence and/
or should be developed to assist FDA in delivering its messages about 
counterfeiting?
    4. How can FDA, other governmental agencies, and private 
stakeholders work together to create and disseminate education messages 
to various audiences (e. g. consumers, wholesalers, pharmacies) that 
are consistent while delivering the information that each stakeholder 
needs?

D. Industry and Health Professional Issues

    1. What is the role of manufacturers, wholesalers, retailers, 
repackagers, and pharmacists in the following areas: (1) Identifying 
counterfeits, (2) preventing the introduction of counterfeits into the 
distribution chain, and (3) educating consumers. Should these 
stakeholders create in-house committees to develop and implement 
security and anti-counterfeit measures? Should stakeholders develop 
compliance programs?
    2. Should a counterfeit drug alert network be developed? If so, 
should it be adapted from existing systems or should a new system be 
created? What would be the associated costs of adapting or creating a 
network?
    We invite public comment on the overall FDA anti-counterfeit drug 
initiative, with a focus on the questions listed previously in this 
document.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, written or electronic comments by November 3, 
2003. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Groups should submit two copies. Individuals may submit one 
copy. Comments are to be identified with the docket number found in 
brackets in the

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heading of this document. You should annotate and organize your 
comments to identify the specific questions to which they refer. To 
ensure timely handling, the outer envelope should be clearly marked 
with the docket number listed in the heading of this document along 
with the statement ``Counterfeit Drug Meeting.'' Comments to the docket 
can be reviewed in the Division of Dockets Management Monday through 
Friday between 9 a.m. and 4 p.m.

IV. Transcripts

    You may request a copy of the transcript of the meeting in writing 
from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, 
approximately 14 working days after the meeting at a cost of 10 cents 
per page or on compact disc at a cost of $14.25 each. You can also 
examine the transcript Monday through Friday between 9 a.m. and 4 p.m. 
in the Division of Dockets Management.

V. Electronic Access

    Persons with access to the Internet may obtain additional 
information on the public meeting at http://www.fda.gov/oc/initiatives/counterfeit/.

    Dated: September 3, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.

[FR Doc. 03-22789 Filed 9-4-03; 8:45 am]
BILLING CODE 4160-01-S