US health secretary overrules FDA’s decision to increase access to emergency contraceptive

BMJ 2011; 343 doi: (Published 12 December 2011) Cite this as: BMJ 2011;343:d8052
  1. Janice Hopkins Tanne
  1. 1New York

Doctors’ leaders and anti-abortion groups have clashed over the decision by the US health secretary, Kathleen Sebelius, to overrule the Food and Drug Administration’s recommendation that the emergency contraceptive pill known as Plan B should be available over the counter in pharmacies to all girls and women.

The FDA’s Center for Drug Evaluation and Research completed its review of an application by Plan B’s manufacturer, Teva Women’s Health, on 30 November and concluded that the drug should be available without a prescription to all girls and women of child bearing potential. The FDA’s commissioner, Margaret Hamburg, later said that the drug was “safe and effective” when taken within one to three days of unprotected intercourse. It contained higher concentrations of a hormone found in some birth control pills and worked in a way similar to birth control pills. In addition, studies showed that young women …

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