Bureaucracy, Virus

H1N1 prompts action on FDA nominee (FiercePharma)

May 5, 2009 — 11:02am ET |
By Tracy Staton

Guess it takes the threat of a flu pandemic to get the U.S. Senate moving on a new FDA commissioner. The Senate Health, Education, Labor and Pensions Committee will now talk about nominee Peggy Hamburg (photo) this Thursday, rather than waiting until next week as planned. Hamburg, not-so-coincidentally, is an expert on pandemics as well as bioterrorism, the Wall Street Journal reports. A spokeswoman for Sen. Ted Kennedy, who chairs the committee, told the paper that it’s a “high priority” to get Dr. Hamburg confirmed, stat–at least in part because her expertise “will be an invaluable resource” in handling the H1N1 outbreak.

Not that FDA has been idle, mind you. Acting chief Joshua Sharfstein (photo) has moved to allow wider use of Roche and GlaxoSmithKline’s antiflu meds, as well as diagnostic tests; he’s also dispatched a variety of FDA teams to work on the issue. The consumer fraud team, for instance, has publicly rebuked a variety of websites for capitalizing on H1N1 fears with unproven flu-fighting claims. And the man coordinating those seven teams–FDA”s new chief medical officer Jesse Goodman–has won kudos from In Vivo and others for his performance so far.

But no one would argue that Hamburg’s assumption of the reins isn’t overdue. Now that her confirmation hearing is imminent, plenty of folks have put together proposed to-do lists–and those lists are quite full, even without H1N1 flu. The latest we’ve seen comes from Eye on FDA, which would like the agency to have more credibility, better and more effective IT, and a clearer approach to risk/benefit analysis and drug-promo rules. What’s yours?

– see the WSJ story
– check out the website piece in The Independent
– read Eye on FDA‘s to-do list
– get In Vivo‘s take on Goodman

ALSO: BNet Pharma points out a loophole in FDA powers: The agency has to sit on its hands, watching adverse event reports pour in, before it can inspect and ban a dietary supplement, as it did earlier this week with Hydroxycut. Report

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