News Release
FOR IMMEDIATE RELEASE Tuesday, March 16, 2004 |
Contact: HHS Press Office (202) 690-6343
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HHS Names Members to Task Force on Drug Importation
HHS Secretary Tommy G. Thompson today named 13 people to serve on
the new Task Force on Drug Importation that is exploring how drug
importation might be conducted safely and its potential impact on
the health of American patients, medical costs and the development
of new medicines.
Surgeon General Richard H. Carmona will serve as the task
force’s chairman. The panel includes
representatives from across HHS, as well as from other parts of the
federal government with knowledge or involvement in drug
importation issues. The task force may consult other federal
officials as well.
“Under Dr. Carmona’s leadership, this task force will
fully examine the issues surrounding drug importation to determine
how to assure consumers that such imported drugs are safe and
effective,” Secretary Thompson said. “We
haven’t been able to provide those safety assurances as
required by law and with available resources. The task force
will study if drugs can be imported safely and, if so, what
resources would be needed to ensure safety.”
Secretary Thompson also announced the dates for the task
force’s five listening sessions with groups and individuals
who would be affected by drug importation. The first
meeting will take place Friday, March 19, and will feature speakers
from at least a dozen invited consumer groups.
The dates of the other listening sessions are: April 2 with health
care purchasers; April 28 with professional health care providers;
May 6 with industry representatives; and May 14 with international
stakeholders.
In addition, the task force will hold a public hearing on April 14
to allow members of the general public to present their views on
the issue. The hearing will take place in the Natcher
Auditorium at HHS’ National Institutes of Health in Bethesda,
Md. Information about participating in the public hearing is
available at http://www.fda.gov/OHRMS/DOCKETS/98fr/04n-0115-nm00001.pdf.
“Secretary Thompson asked the task force to assess the issue
of drug importation safety and the associated public health
issues,” Dr. Carmona said. “I am looking forward
to working with task force members as we conduct a fair and
objective evaluation based on the best science and information
available.”
In addition to Dr. Carmona, the task force members are:
Jayson P. Ahern, assistant commissioner in the Office of Field
Operations, U.S. Customs and Border Protection, Department of
Homeland Security.
Alex M. Azar II, HHS general counsel;
Josefina Carbonell, HHS assistant secretary for aging;
Lester M. Crawford, D.V.M., Ph.D., FDA deputy commissioner;
Elizabeth M. Duke, Ph.D., administrator of HHS' Health Resources Services Administration;
Mark B. McClellan, M.D., Ph.D., incoming administrator for
HHS’ Centers for Medicare & Medicaid Services;
Mike O'Grady, HHS’ assistant secretary for planning and
evaluation;
William Raub, HHS’ deputy assistant secretary for public
health emergency preparedness;
Tom Reilly, public health branch chief at the White House Office of
Management and Budget;
Amit K. Sachdev, acting FDA deputy commissioner for policy;
Elizabeth A. Willis, chief of the Drug Operations Section, Office
of Diversion Control, U.S. Drug Enforcement Administration; and
Colette Winston, a trial attorney at the Department of Justice.
The task force’s members ultimately will offer
recommendations to Secretary Thompson on how best to address the
key questions posed by Congress as part of the Medicare
Prescription Drug, Improvement and Modernization Act of 2003.
The legislation directed HHS to complete a study by December 2004
to address the following issues related to drug importation:
Identify the limitations, including
limitations in resources and in current legal authorities, that may
inhibit the Secretary’s ability to certify the safety of
imported drugs.
Assess the pharmaceutical distribution
chain and the need for, and feasibility of, modifications in order
to assure the safety of imported products.
Analyze whether anti-counterfeiting
technologies could improve the safety of products in the domestic
market as well as those products that may be imported.
Estimate the costs borne by entities
within the distribution chain to utilize such anti-counterfeiting
technologies.
Assess the scope, volume and safety of
unapproved drugs, including controlled substances, entering the
United States via mail shipment.
Determine the extent to which foreign
health agencies are willing and able to ensure the safety of drugs
being exported from their countries to the U.S.
Assess the potential short- and
long-term impacts on drug prices and prices for consumers
associated with importing drugs from Canada and other countries.
Assess the impact on drug research and
development, and the associated impact on consumers and patients,
if importation were permitted.
Estimate agency resources, including
additional field personnel, needed to adequately inspect the
current amount of pharmaceuticals entering the country.
Identify the liability protections, if
any, that should be in place if importation is permitted for
entities within the pharmaceutical distribution chain.
Identify ways in which importation could
violate U.S. and international intellectual property rights and
describe the additional legal protections and agency resources that
would be needed to protect those rights.
A public docket for the task force will be opened tomorrow to allow
members of the public to submit comments for the record. The
docket, 2004N-0115, will be available at
http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm.
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Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.
Last Revised: March 23, 2004
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