Author Affiliations: Editor Emeritus, Annals of Internal Medicine, and Executive Editor, Institute for Healthcare Improvement, Cambridge, Mass (Dr Davidoff); and Director, Office of Population Research, Princeton University, Princeton, NJ (Dr Trussell).
The August 24, 2006, decision by the US Food and Drug Administration (FDA) to approve over-the-counter (OTC) sales of the emergency contraceptive Plan B—1.5 mg of levonorgestrel taken after unprotected sexual intercourse—was a major development in a long and contentious regulatory process. Since the drug is more effective the sooner it is used, the delay in obtaining it imposed by its prior prescription-only status limited its effectiveness.
In the interest of making Plan B available more quickly when needed, the distributor (Women's Capital Corp, Washington, DC) applied to the FDA in April 2003 for approval of OTC status. In December 2003, a joint FDA advisory committee voted 23-4 in favor of approval. It did so on the basis of evidence that the drug is both effective and safe and that it met all FDA criteria for OTC availability. The committee also took into account the likelihood that improved access could prevent at least some of the 3.1 million unintended pregnancies (including the 25 000 that result from rape)1,2—and, hence, some of the more than 1 million elective abortions—that occur in the United States every year.1 Although the FDA almost always accepts its advisory committees' recommendations, in the case of Plan B it twice refused to grant approval of OTC status; the current approval decision came nearly 3 years from the time of the committee vote.
Davidoff F, Trussell J. Plan B and the Politics of Doubt. JAMA. 2006;296(14):1775–1778. doi:10.1001/jama.296.14.1775
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