Saturday, May 12, 2007

Senate Passes FDA Reform Bill

Article in the New York Times -- Passage of Drug Safety Bill Was Common Goal for Two Very Different Senators, by Robert Pear and Gardiner Harris.  Here's an excerpt:

Legislation to beef up drug safety, passed by the Senate this week with only one dissenting vote, grew out of an extraordinary pact between two senators and a frantic effort by the pharmaceutical industry to avoid any disruption in the approval of new drugs.

The bill would increase the fees paid by drug makers to help finance the work of the Food and Drug Administration and would give the agency new power to police company conduct.

Industry lobbyists and executives said they supported the bill for one overriding reason: pink slips.

Sometime this summer, if a bill has not passed, medical officers at the F.D.A. will start getting notices that they are in danger of being laid off by the end of the fiscal year on Sept. 30. Some of those officers are likely to be in the midst of reviewing new drug applications crucial to the future of drug makers.

If those medical officers leave, drug approvals may be delayed — a terrifying prospect for many companies.


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