BMJ  2005;331:1223 (26 November), doi:10.1136/bmj.331.7527.1223-a

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FDA criticised for rejecting over the counter emergency contraception

New York

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

The US Food and Drug Administration's decision to refuse to approve over the counter status for the emergency contraceptive Plan B (levonorgestrel) was flawed, unusual, and not standard FDA procedure. This is finding of a report by the Government Accountability Office, an independent investigative agency of the US Congress.

Two FDA officials resigned in protest over the denial ( BMJ 2005;331: 532, 861[Free Full Text]). Lester Crawford's approval as the FDA's commissioner was also delayed as a direct result of the furore. He resigned shortly after his confirmation but did not cite any specific issue as the reason for his decision ( BMJ 2005;331: 713[Free Full Text]).

Forty eight senators and representatives had asked the accountability office to investigate why the FDA had rejected over the counter status for Plan B ( BMJ 2005;328: 1219).

Plan B was approved for use . . . [Full text of this article]

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