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  FDA's Role in Blocking 'Morning-After' Pill Cited
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ContributorArmyDem 
Last EditedArmyDem  May 25, 2006 10:40pm
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CategoryNews
MediaNewspaper - Los Angeles Times
News DateFriday, May 26, 2006 04:00:00 AM UTC0:0
DescriptionThe agency's last two chiefs overruled staff on whether the drug should be over-the-counter, court transcripts say.

By Ricardo Alonso-Zaldivar, Times Staff Writer
May 25, 2006

WASHINGTON — The last two appointees to head the FDA were closely involved in decisions to overrule the agency's medical reviewers and block the "morning-after" birth control pill from being sold without a prescription, according to court transcripts to be released today.

Last year, Lester M. Crawford personally took the decision away from his top subordinates, according to depositions of two senior Food and Drug Administration officials. And at an earlier stage in the process, his immediate predecessor as FDA commissioner, Mark B. McClellan, raised objections that formed the basis for overruling medical reviewers.

The transcripts provide the most detailed look yet at an internal review that some critics say has been tainted by politics. The dispute over the drug, marketed as Plan B, has pitted Christian conservatives against liberal women's groups and raised concerns in academic circles that the FDA had compromised its scientific principles.
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