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News of the Day ... In Perspective

11/13/2006

FDA sued over mercury in medicines

On Oct 27, the Coalition for Mercury-free Drugs (CoMeD) filed an amended complaint in U.S. federal court, disputing a Sept 26 FDA response defending the use of mercury in medications.

The lawsuit, originally filed in August 2006, asks the court to force the FDA to comply with existing law and regulations and provide proof of the safety and efficacy of mercury in drugs. The suit was filed because the FDA failed to answer issues raised in a citizen petition filed on Aug 4, 2004, by CoMeD representatives.

Mercury is found in at least 45 different prescribed or over-the-counter drugs, including eye ointments, nasal sprays, and vaccines, most importantly, flu vaccines administered to children and pregnant women.

In a 1999 internal email, obtained under a Freedom of Information Act request, an FDA official wrote that the agency’s failure to evaluate the cumulative amount of mercury in medicine “…will raise questions about FDA being ‘asleep at the switch’ for decades by allowing a potentially hazardous compound to remain…and not forcing manufacturers to exclude it from new products….”

In a second email, the same official wrote: “…the greatest point of vulnerability on this issue is that the systematic review…by the FDA could have been done years ago and on an ongoing basis.”

In a letter by FDA Acting Assistant Commissioner for Policy Jeffrey Shuren, denying the CoMeD petition, the “admission that the FDA had no substantive evidence confirming the safety of mercury in medicine was stunning,” stated CoMeD.

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