FDA violation warnings dropped 50% under Bush administration: congressman

[JURIST] The US Food and Drug Administration (FDA) [official website] issued 50% fewer warning letters [press release] to companies violating federal drug and safety regulations in the past five years under the Bush administration, according to a report [PDF text] released Monday by US Rep. Henry Waxman (D-CA) [official website]. In 2000, the FDA issued 1,154 warning letters [yearly archives], while in 2005, only 535 letters went out, and Waxman said the numbers dropped despite a constant level of violations. David Elder, the director of the FDA Office of Enforcement, responded by saying the number of letters sent does not accurately reflect the agency's activities, noting that the department has instead focused its efforts on blocking major health risks to the public resulting in $2.5 billion in fines and restitutions since 2000.

Waxman's investigative report also cites recommendations by FDA field monitors during site inspections that were rejected by departmental officials. One incident involved the lack of a warning to a company that marketed a drug to remedy hangovers which contained toxic caffeine amounts. Waxman said the FDA's response that it does not keep a record of violation recommendations is a breach of federal documentation tracking laws. AP has more.

 

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