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Democrats oppose plan on drug label changes

Pharma Compliance Alert, January 30, 2008

Eight congressional Democrats want the FDA to reconsider its plan to allow pharmaceutical and medical device manufacturers to change their product labels, according to the Washington Post.

The proposed change will allow manufacturers to update product labels with new safety information without waiting for FDA approval.

Representatives Henry Waxman (D-CA), John Dingell (D-MI), Frank Pallone (D-NJ), Rosa DeLauro (D-CT), and Edward Markey (D-MA), and Senators Edward Kennedy (D-MA), Patrick Leahy (D-VT), and Christopher Dodd (D-CT) all signed a letter sent to the FDA objecting to the change.

The FDA proposed changing what information pharmaceutical and medical device manufacturers can modify without the agency's approval. According to the letter, the proposal will "shield pharmaceutical and device companies from liability for injuries sustained by American consumers as a result of unsafe products."

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