Partnership for Safe Medicines Issues Statement About FDA Foreign Drug Inspection Program
WASHINGTON, DC (April 22, 2008) – 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 Partnership 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 SafeMedicines.org.
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