Dingell promises drug safety oversight

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The new Democratic leadership is poised to conduct more oversight of the Bush administration in 2007, particularly on issues involving Medicare Part D and the FDA, according to House Committee on Energy and Commerce incoming chairman John Dingell (D-MI).

Asked on Fox News Sunday with Chris Wallace about specific investigations he'd like to pursue, Dingell said: “There are questions relative to food and drug safety, generics and licensing. But also food supplements, where people are being killed.” Dingell's reference to “generics and licensing” was taken as referring to authorized generics.

Additionally, last February Dingell and his like-minded colleague, Henry A. Waxman (DA-CA), who will head the House Government Reform Committee, objected to the FDA's policy statement on preemption of state law as part of its prescription drug labeling rule.

“The Bush administration's preemption claim reverses a long-standing FDA policy of permitting complementary state activities intended to protect consumers from unsafe drugs,” they wrote. “Although this policy reversal will substantially undermine states' ability to protect their citizens, neither affected state and local entities, nor the general public were given an opportunity to comment.”

Dingell has also questioned the FDA's reliance on non-inferiority trials in showing effectiveness in antibiotic submissions, and has asked the Government Accountability Office to examine the issue further.

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