Dingell promises drug safety oversight

Share this article:
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.

Share this article:

Email Newsletters

More in News

House bill would speed approval once EU OKs same product

House bill would speed approval once EU OKs ...

The Speeding Access to Already Approved Pharmaceuticals Act of 2014 would require FDA to expedite the review of pharmaceuticals that are already approved by the European Union

Rep access continues to shrink

Rep access continues to shrink

Sales reps are experiencing even more limited physician access, according to a report by Chicago consultancy ZS Associates.

Allergan touts reorg, plans to lay off 13% of workforce

Allergan touts reorg, plans to lay off 13% ...

Allergan's second-quarter earnings, and a new round of cuts, are now part of the Botox maker's record as it seeks to remain independent.