[Federal Register: March 18, 2004 (Volume 69, Number 53)]
[Proposed Rules]
[Page 12810-12811]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18mr04-17]
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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: Karen.Strambler@fda.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: efrench@oc.fda.gov.
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
[[Page 12811]]
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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