Partnership for Safe Medicines Issues Statement About FDA Foreign Drug Inspection Program

Released on: April 22, 2008, 7:47 am

Press Release Author: The Partnership for Safe Medicines

Industry: Pharmaceuticals

Press Release Summary: The Partnership for Safe Medicines issued a statement
regarding today\'s hearing on the Food and Drug Administration's (FDA) efforts to
inspect foreign drug plants making products for the U.S. market held by the House
Committee on Energy and Commerce's Subcommittee on Oversight and Investigations.

Press Release Body: WASHINGTON, DC - The Partnership for Safe Medicines, a group of
organizations and individuals dedicated to protect consumers from counterfeit
medicines, issued the following statement regarding today\'s hearing on the Food and
Drug Administration's (FDA) efforts to inspect foreign drug plants making products
for the U.S. market held by the House Committee on Energy and Commerce's
Subcommittee on Oversight and Investigations.

The Partnership for Safe Medicines echoes the concerns expressed by Congressmen
Dingell, Barton, Stupak and Shimkus about the state of the FDA's foreign drug
inspection program. There is a strong need for strict, rigorous regulatory oversight
of imported drugs to keep situations such as the recent heparin contamination from
repeating in the future. However, progress in the fight against counterfeit and
contaminated medications is unforeseeable unless we give the FDA all the tools it
truly needs to fix the problems.

The FDA needs a dramatic, and sustained, increase in funding in order to properly
inspect the foreign manufacturing facilities producing the active pharmaceutical
ingredient (API) in America's drugs. It needs the resources to open permanent field
offices in China, India and other key exporting countries staffed with both
inspectors and criminal investigators.

This Subcommittee hearing addresses key issues core to our mission - to protect
consumers from contraband and counterfeit medicines. The Partnership continues to
encourage consumers to learn how to protect themselves from potentially dangerous
medicines while Congress and the FDA work together to improve its capacity to
properly regulate pharmaceutical importation.

# # #

About the Partnerships for Safe Medicines
The Partnership for Safe Medicines is a group of organizations and individuals that
have policies, procedures, or programs to protect consumers from counterfeit or
contraband medicines. For more information, please visit
http://www.safemedicines.org.

Web Site: http://www.safemedicines.org

Contact Details: Deborah Danuser
202-742-5256
deborah@jonespa.com

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