Friday, April 08, 2005

FDA's move against Bextra (despite advisory committee's recommendations)

I was very surprised to read that the FDA, against their own advisory committee's recommendations, rejected the approval of Pfizer Pharmaceutical's Bextra for marketing. The FDA's decision to overule their committee in this manner seems to be extremely rare.

The only other time I know of this happening was in 2004 when against committee recommendations, the FDA failed to grant approval to Plan B, a morning after pill. I'm trying to determine the overall frequency of such occurrences.

The press has yet to report on just what the FDA's reasons for the rejection were. Of course I'm wondering if it has to do anything with the statistically obvious bias manifested by the committee members with financial ties to Pfizer and Merck.

For my more cynical readers, I will say this: although the FDA can never be realistically thought of as "apolitical", to make such a decidedly anti-big-pharma decision is quite striking. It will be very interesting to find out more information regarding the FDA's reasoning as the press reports it.



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