[Federal Register Volume 69, Number 53 (Thursday, March 18, 2004)]
[Proposed Rules]
[Pages 12810-12811]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-6145]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. 2004N-0115]


Prescription Drug Importation; Public Meeting and Establishment 
of Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting and establishment of docket.

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    The Food and Drug Administration (FDA), on behalf of the U.S. 
Department of Health and Human Services' (HHS) Task Force on Drug 
Importation, is announcing that it is establishing a docket to receive 
information and comments on certain issues related to the importation 
of prescription drugs. FDA is also announcing a public meeting to 
enable interested individuals, organizations, and other stakeholders to 
present information to the Task Force for consideration in the study on 
importation mandated by the Medicare Prescription Drug, Improvement and 
Modernization Act of 2003. The Task Force is particularly interested in 
information related to whether and under what circumstances drug 
importation could be conducted safely, and what its likely consequences 
would be for the health, medical costs, and development of new 
medicines for American patients.
    Date and Time: The public meeting will be held on April 14, 2004, 
from 9 a.m. to 5 p.m.
    Location: The public meeting will be held at the Natcher 
Auditorium, Building 45, National Institutes of Health (NIH), 9000 
Rockville Pike, Bethesda, MD 20892. Parking will be limited and there 
may be delays entering the NIH campus due to increased security. We 
recommend arriving by Metro if possible. NIH is accessible from the 
Metro's red line at the Medical Center/NIH stop.
    Contact Person: Karen Strambler, Office of Policy, Office of the 
Commissioner, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-3360, e-mail: [email protected].
    Registration and Requests for Oral Presentation: No registration is 
required to attend the public meeting. Seating will be on a first-come, 
first-serve basis. If you wish to present at the public meeting, please 
submit your request and a summary of your presentation to Karen 
Strambler the contact person listed in this document. Requests should 
be identified with the docket number listed in brackets in the heading 
of this document. (To ensure timely handling, the outer envelope should 
be clearly marked with the docket number listed in brackets in the 
heading of this document and the statement ``Prescription Drug 
Importation Public Meeting.'')
    Speakers must submit requests for presentations along with a short 
summary of their presentation by close of business on March 30, 2004. 
Presenters must send final electronic presentations, if any, in 
PowerPoint, Microsoft Word, or Adobe Portable Document Format (PDF) to 
Karen Strambler the contact person listed in this document by close of 
business on April 7, 2004.
    The public docket will formally remain open until June 1, 2004, and 
we encourage commenters to submit written and electronic comments 
before that date. However, FDA recognizes that there may be a need for 
further public input, and will be prepared to accept additional 
comments beyond this date as necessary. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments. Submit written comments to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Requests to present should contain the following information:
     Presenter's name;
     Address;
     Telephone number;
     E-mail address;
     Fax number;
     Affiliation, if any;
     Summary of the presentation; and
     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 will 
schedule each appearance and notify each participant by e-mail or 
telephone of the time allotted to the participant and the approximate 
time the participant's presentation is scheduled to begin.
    Presenters must send final electronic presentations, if any, in 
Microsoft PowerPoint, Microsoft Word, or PDF to Karen Strambler the 
contact person listed in this document by close of business on April 7, 
2004.
    If you need special accommodations due to disability, please inform 
Elizabeth French, Office of Policy (HF-11), Office of the Commissioner, 
Food and Drug Administration, 5600 Fishers Lane, rm. 14-101, Rockville, 
MD 20857, 301-827-3360, FAX: 301-594-6777, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On December 8, 2003, President Bush signed the Medicare 
Prescription Drug, Improvement and Modernization Act of 2003 (Medicare 
Modernization Act) (Public Law 108-173). Section 1121 of this 
legislation gives the Secretary of HHS (the Secretary) the authority to 
implement a system in the United States for the importation of Canadian 
prescription drugs. However, the Secretary is permitted to implement 
such a system only if he is first able to certify to the Congress that 
it would be safe and cost-effective. Section 1122 of this legislation 
also directs the Secretary to conduct a study that examines whether and 
under what circumstances drug importation could be conducted safely, 
and what its likely consequences would be for the health, medical 
costs, and development of new medicines for American patients. To 
comply with the Congressional mandate, the Secretary has formed the 
Task Force on Drug Importation to advise and assist HHS in this study. 
The Task Force plans to consider several issues in the study, including 
several that Congress specifically asked HHS to consider. To assist in 
this effort we are asking for public comment on the following issues, 
which the Conference Report to the Medicare Modernization Act directs 
us to address in the study:
     Impact of Unapproved Drugs: What is the scope 
and volume of unapproved drugs entering the United States through mail 
shipments and at border crossings? What are the safety concerns posed 
by these products? What evidence exists to substantiate these concerns? 
Can they be quantified? What is the scope and

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volume of FDA-approved drugs commercially available in other countries?
     FDA's Ability to Assure Safety: What should FDA 
do to assure safety of imported products? Should FDA examine all 
imports, or should a sampling method, along with testing, be used to 
assure safety? What resources would FDA need for different levels of 
oversight, which could include visual inspection, sampling, and other 
testing methods to determine quality? Is there a need for, and what is 
the feasibility of, modifications to the U.S. pharmaceutical 
distribution system that would help to ensure the safety of drug 
products imported into the United States under section 1121 of the 
Prescription Drug, Improvement and Modernization Act of 2003?
     Regulatory/Legislative Issues: What, if any, 
limitations in current legal authorities, such as sections 505, 502, 
and 801 of the Federal Food, Drug, and Cosmetic Act (the act) (21 
U.S.C. 355, 352, and 381), may inhibit the Secretary's ability to 
certify that prescription drugs imported into the United States from 
Canadian wholesalers or pharmacies are safe? What, if any, limitations 
in current legal authorities may inhibit the Secretary's ability to 
certify whether the imported drugs comply with sections 505, 502, and 
501 of the act (21 U.S.C. 351) (e.g., Are the drugs approved by FDA?, 
Do they contain appropriate labeling?, Are they manufactured according 
to current Good Manufacturing Practice)? If FDA could not assure the 
same level of safety for imported drugs as consumers expect from drugs 
purchased at a State-licensed pharmacy, what level of risk would be 
acceptable?
    In what ways would importation of drugs, if permitted under section 
1121 of the Medicare Modernization Act, impact U.S. and international 
intellectual property rights as well as obligations under existing 
trade agreements? Are there additional legal protections needed for 
effective enforcement of these rights and agreements?
     Technology: What anti-counterfeiting 
technologies are available and feasible to use to improve the safety of 
products in the domestic market as well as to prevent the importation 
of unapproved or counterfeited drug products? What costs would be 
associated with the implementation of such technologies?
     Financial Impact: What would be the short and 
long term financial impact on drug prices, on drug manufacturers, on 
pharmacies, on wholesalers, and on patients if section 1121 were to be 
implemented? What other system costs could be associated with 
importation of pharmaceuticals from Canada and other countries into the 
United States?
     Research and Development: What would be the 
impact on research and development of drugs and the associated impact 
on consumers and patients, if section 1121 of the Prescription Drug, 
Improvement and Modernization Act of 2003 were to be implemented? Would 
a reduction in domestic pharmaceutical sales result over time in 
reduced investment in developing new drugs for the future?
     Liability Issues: What, if any, liability 
concerns would exist for entities in the U.S. pharmaceutical 
distribution system if importation of drugs from Canada or another 
country were permitted? If liability concerns do exist, what liability 
protections do you believe should be implemented?
     Regulation by Foreign Health Agencies: What 
protections do other countries have in place to ensure the safety of 
drugs that are exported or transshipped from their country to the 
United States? If these protections are lacking, to what extent are 
foreign health agencies willing or able to implement new or additional 
protections to ensure safety of exported or transshipped drugs?

II. Comments

    Interested persons should submit to the Division of Dockets 
Management (see Registration and Requests for Oral Presentation) 
written or electronic comments regarding this document by June 1, 2004. 
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. Comments received may be reviewed in 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

III. Transcripts

    Transcripts of the public meeting may be requested in writing from 
the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, 
approximately 15 working days after the meeting at a cost of 10 cents 
per page or a CD at a cost of $14.25 each.

IV. Electronic Access

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

    Dated: March 15, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-6145 Filed 3-16-04; 8:45 am]
BILLING CODE 4160-01-S