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 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 by prescription in 1999. In April 2003, the manufacturer, Barr, applied to the FDA for over the counter status. The application was reviewed by several FDA offices and by two independent FDA advisory committees. The advisory committees voted 23 to four in favour of over the counter status, and the FDA's staff recommended approval.

But Steven Galson, then acting head of the Center for Drug Evaluation and Research (and now head) rejected the application, saying that women aged under 16 might not understand the instructions.

Barr then applied for over the counter use by older women and prescription only use for those 16 or younger. Instead, the FDA called for a period of public comment, which has just ended, and said that it would make a decision later ( BMJ 2005;331: 596[Free Full Text]).

The accountability office's report said that high level FDA management was more involved in considering over the counter status of Plan B than of other drugs being switched from prescription to over the counter, it said.

Planned Parenthood said that Plan B was the only drug denied a switch to over the counter use after advisory committees recommended approval. Also, there were no age restrictions on other FDA approved prescription or over the counter contraceptives.

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Longer versions of these articles are on bmj.com

Decision Process to Deny Application for over the Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual, is available at www.gao.gov/new.items/d06109.pdf.

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