Morning-After Pill Approved

After years of wrangling and delays, FDA accepts a bid to make Plan B emergency contraceptives available for over-the-counter sales t o women 18 and older

After more than three years of wrangling and delays, the U.S. Food and Drug Administration on Aug. 24 finally approved a bid to make Plan B emergency contraceptives (the so-called "morning-after pill") available for over-the-counter sales to women 18 and older. Plan B contains a higher than normal dose of the hormones contained in regular birth control pills and is used to prevent unwanted pregnancy when taken within 72 hours of unprotected sex. Although the FDA's science advisers overwhelmingly agreed that Plan B should be made available for over-the-counter sales, in May 2004, then agency administrator Mark McClellan rejected the panel's conclusion and denied Plan B OTC status – a move that prompted at least two high-ranking FDA officials to resign from the agency, including Dr. Susan Wood, who served as director of the FDA Office of Women's Health.

Earlier this month, however, the Plan B logjam broke after Sens. Patty Murray, D-Wash., and Hillary Rodham Clinton, D-N.Y., pledged to halt the confirmation process for acting FDA Commissioner Andrew von Eschenbach until the agency made a final decision on whether to approve Plan B for nonprescription sales. In the wake of the agency's announcement last week, Murray and Clinton said they would allow von Eschenbach's confirmation hearings to proceed – the Plan B approval "demonstrates the agency is returning to its original mission of science over politics," Clinton told reporters.

Nonetheless, it appears the FDA will still have a morning-after hangover to deal with: Nancy Northrup, president of the New York-based Center for Reproductive Rights, which had sued the government over the Plan B delays, says her group will continue with its suit, in part because of the feds' decision to restrict OTC sales to women 18 and older, meaning that those younger than 18 will still need a prescription to buy emergency contraceptives. The FDA, she says, has "chosen to abandon young women – the most vulnerable population – and left them to jump through hoops to get access to emergency contraceptives." And the conservative Family Research Council has also vowed to sue the FDA, arguing that the agency somehow overstepped its rule-making authority by approving OTC sales of the drug, which the FRC persists in referring to as an abortifacient. "The cost to women's mental and physical health ... a predictable increase in promiscuous sex, the loss of life to millions of tiny embryonic babies ... make [Plan B approval] a major setback to any 'culture of life' in America," the FRC opines on its Web site.

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