BMJ  2006;332:624 (18 March), doi:10.1136/bmj.332.7542.624-b

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FDA rejected contraception for political reasons

News York

The first 150 words of the full text of this article appear below.

The US Food and Drug Administration "created a regulatory catch 22 to justify the predetermined political decision to block over the counter sales of [the emergency contraceptive] Plan B [levonorgestrel]," representative Henry Waxman, a California Democrat, claimed last week.

He sent a seven page letter relying on "previously undisclosed documents" to Andrew von Eschenbach, the acting commissioner of the FDA. In the letter he charges that the FDA "created the situation it now protests as too complex to solve" and "seriously mischaracterised its consideration of the regulatory questions at stake."

He wrote that the documents "further undermine the agency's contention that the Plan B decision was based on legitimate science-based factors." He asked Dr von Eschenbach to explain the FDA's action by 27 March 2005.

Plan B has been available on prescription in the United States since 1999. Barr Pharmaceuticals, the manufacturer, applied to the FDA to make it available . . . [Full text of this article]

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