Reforming the FDA It All Starts with a New Commissioner! NOT!
Shiny New FDA“[The Committee on Energy and Commerce in the US House andRepresentatives] has found that FDA not only failed in its basicmission, but refused to admit its failures and take steps to protectAmericans from unsafe food and drugs,” said Rep. John D. Dingell(D-MI), former chairman of that committee. “In the 111th Congress, thecommittee will swiftly move FDA reform legislation that is needed toensure FDA does its job.” Now that Henry Waxman is the new chairman,”swift” may be inadequate to describe the changes ahead for the FDA.

Thebiggest and possibly most important change, however, is whoPresident-elect Obama and his Secretary of HHS, Tom Daschle, decide tonominate for the new FDA Commissioner.

Itseems like everyone in the Pharma Blogosphere and the press isrecommending or wondering who Dr. Andrew von Eschenbach’s replacementwill be.

To help take the pulse of various stakeholders, PharmaMarketing News hosted the “Who Should Obama Nominate for FDACommissioner?” survey starting in November, 2008. 475consumers, healthcare professionals, government agency staffers, anddrug industry executives have voted in this survey. This articlesummarizes the results.

Topic headings include:

  • Obama In, Eschenbach Out!
  • The Pundits Weigh In
  • The Candidates
  • Profile of Respondents
  • And the Winner Is…
  • Peter Rost – A Special Case 
  • Who Voted for Whom?
  • Comments from Voters and Candidates

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Update (December, 2011): Replacing the FDA Commissioner may have been a necessary, but NOT SUFFICIENT pre-requisite for reforming the FDA. Not even a reform-minded commissioner like Margaret Hamburg, M.D. — who was nominated to the post after this article was first published — can change things when the FDA is beholding to the Department of Health and Human Services. This was made evident when HHS Secretary Kathleen Sebelius over-rode FDA’s decision to allow the over-the-couinter sale of Plan B One-Step to girls younger than 17 (see “Sebelius vs. Hamburg on OTC Plan B Decision“).

Meanwhile, there is a new call for FDA reform that would take the F.D.A. out of the Department of Health and Human Services and make it an independent agency, like the Fed (op cit).

Issue: Vol. 7, No. 10: December 2008
Word Count: 5868

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