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International Medical Community Urges FDA to Approve Plan B for OTC

In a recent editorial, a leading international medical journal urged the US Food and Drug Administration (FDA) to maintain unbiased standards when determining the availability of emergency contraception for over-the-counter distribution. The Lancet article specifically calls for Andrew von Eschenbach, acting FDA commissioner, to issue an impartial decision regarding the drug, known as ‘Plan B,’ to reassert his credibility and that of the organization. “The agency is stalling, apparently to avoid offending antiabortion supporters of President Bush, who claim that the contraceptive is an abortofacient,” the editorial argued. In addition, the editorial asserts that Von Eschebach’s effectiveness as a commissioner is dependent upon his ability to follow the recommendations of the FDA’s scientific advisors. “The FDA must be led by a commissioner willing to take independent standsÉeven when incurring the wrath of patient groups, industry, Congress, and the White House,” The Lancet editorial said.

Though two advisory committees to the FDA voted almost unanimously for EC’s approval, the agency has not issued a final decision. Susan Wood, director of the Office of Women’s Health, resigned in August 2005, citing the FDA’s failure to reach a verdict as her reason for leaving (See Ms., Winter 2006). The FDA’s lack of action has provoked outrage and accusations of partisan bias from women’s groups and other supporters. Democrats in Congress have pledged to block the confirmation of acting FDA Commissioner Andrew von Eschenbach until a ruling is announced.

Women’s health advocates and medical professionals have been frustrated by the delayed approval of OTC because Plan B is most effective when taken immediately. It also has the potential to eliminate nearly half of the unwanted pregnancies in the US. Many groups, such as the Feminist Majority Foundation, have initiated campaigns to increase access to and awareness of EC. The latest “Ask Me” campaign created by the American College of Obstetricians and Gynecologists (ACOG) encourages doctors to give their sexually active patients advance prescriptions for Plan B to ensure access to the drug in a timely fashion.

Take Action Urge the FDA to approve Plan B for OTC Distribution

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Sources:

ABC Online News 5/8/06; Feminist Daily News 5/9/06; New York Times 5/18/06;