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Partnership for Safe Medicines Supports Change in Foreign Inspection Process

Consumer safety group calls for FDA to have foreign inspectors and criminal investigators armed with the same authority as their State-side colleagues.


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April 29, 2008 (FPRC) -- 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 examination of the events leading up to the distribution of contaminated heparin and Chinese plant inspections held by the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations.

“The Partnership for Safe Medicines applauds the Subcommittee for recognizing the importance and urgency of eliminating contaminated drugs. Unfortunately, this recent case of heparin contamination is just one example of the increasingly global problem of counterfeit drugs sold to an unsuspecting public.

“Today’s hearing is a step in the right direction. It is important to better understand what went wrong and what solutions are necessary to ensure the safety of our prescription medicines. But we can’t stop there. The FDA needs to open permanent field offices in key exporting countries and it must staff those offices with inspectors and criminal investigators armed with the same authority as their State-side colleagues. The FDA needs to be granted the authority to enter and inspect foreign manufacturing facilities without previous notice.

“While we reflect on the events leading up to this tragedy, the Partnership encourages everyone to learn how they can take steps to protect themselves from contraband and potentially counterfeit medicines—because counterfeit drugs are unsafe at any cost.”

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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.

Send an email to Deborah Danuser of Partnership for Safe Medicines
202 742-5256

Keywords: Safe Medicines, counterfeit drugs, subcommittee hearing


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