November 15, 2005

More perfidy at FDA

A new GAO report (pdf) indicates there was no intent to approve the morning-after pill and in fact every intent to disapprove it, no matter the consensus of the review panel.

Right-wing politics endangers lives:

FDA officials gave conflicting accounts of when the not-approvable decision for the Plan B OTC switch application was made. FDA officials, including the Director and Deputy Director of the Office of New Drugs and the Directors of the Offices of Drug Evaluation III and V, told us that they were told by high-level management that the Plan B OTC switch application would be denied months before staff had completed their reviews of the application. The Director and Deputy Director of the Office of New Drugs told us that they were told by the Acting Deputy Commissioner for Operations43 and the Acting Director of CDER, after the Plan B public meeting in December 2003, that the decision on the Plan B application would be not-approvable. They informed us that they were also told that the direction for this decision came from the Office of the Commissioner. The Acting Deputy Commissioner for Operations and the Acting Director of CDER denied that they had said that the application would not be approved. In addition, although minutes of the January 15, 2004, meeting stated that the Acting Director told review staff that a not-approvable decision was “recommended,” review staff documented that they were told at this meeting that the decision would be not-approvable. Both office reviews were not completed until April 2004.

So if a woman has been raped and needs the morning-after pill, that's too damn bad. No doubt she put herself in a compromising position and she should pay for it with an unwanted pregnancy.

Add this to the argument against vaccination for human papilloma virus (see here), and you can see how dangerous it is for politicians to interfere with science.

NYT story here.

Posted by Linkmeister at November 15, 2005 10:47 AM | TrackBack
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