FDA ducks decision on emergency contraceptive

BMJ 2005; 331 doi: (Published 15 September 2005) Cite this as: BMJ 2005;331:596
  1. Janice Hopkins Tanne
  1. New York

    Janice Hopkins Tanne looks at why emergency contraception is proving so controversial in the United States, even though it is now available without prescription in nearly 40 countries

    A furore has erupted in the United States after the announcement by Dr Lester Crawford, commissioner of the Food and Drug Administration (FDA), that he was going to postpone indefinitely a decision to make emergency contraception available over the counter, even though two FDA committees have recommended such availability (BMJ 2005;331: 532, 10 Sep).

    An assistant commissioner at the FDA resigned over the issue, and 13 senators asked the independent Government Accounting Office to accelerate the investigation of the FDA's actions, which the senators had requested in June 2004.

    Major newspapers from coast to coast castigated the FDA; almost none spoke in its support.

    The consensus was that the FDA had abandoned science and was knuckling under to political pressure from conservatives who oppose abortion and confuse emergency contraception with abortion.

    Susan Wood resigned as assistant commissioner for women's health and director of the FDA's Office of Women's Health, saying that the FDA was no longer making decisions on scientific grounds.

    Dr Wood, who had just completed eight months in the UK Department of Health on a fellowship, said that Dr Crawford's decision to postpone making a decision had nothing to do with the safety or the efficacy of the drug, Plan B, made by Barr. …

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