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:
You must be a registered member of MMM to post a comment.


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...