FDA's Morning-After Pill Shift Stirs Debate

April 22, 2009— -- For Susan Wood, Wednesday's announcement by the U.S. Food and Drug Administration may have offered a degree of vindication that has been nearly four years in the making.

In August 2005, Wood -- formerly the assistant FDA commissioner for women's health and director of the Office of Women's Health -- resigned from her post over a decision by the agency to further delay over-the-counter access to the Plan B contraceptive, also known as the morning after pill.

One year later, the FDA approved the over-the-counter sale of the pill to women 18 and older without a prescription.

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On Wednesday, the agency announced a full reversal of its prior reticence with regard to Plan B -- extending the contraceptive's over-the-counter status to 17-year-old women as well.

"It's a start," Wood said. "It is not the be-all and end-all. It's one more step in the right direction."

The move on Plan B had been widely anticipated since last month, when a U.S. District Court rejected a Food and Drug Administration decision to limit over-the-counter access to the emergency contraceptive to women 18 and older -- and further stipulated that the FDA act within 30 days to extend over-the-counter access to the pill to 17 year olds.

While the FDA originally did not move on the issue of whether the pill should be available prescription-free to 17-year-olds, it appears that it will not contest the court's order.

"The government will not appeal this decision," the FDA said in a brief statement issued Wednesday afternoon. "In accordance with the court's order, and consistent with the scientific findings since 2005 by the Center for Drug Evaluation and Research, FDA sent a letter to the manufacturer of Plan B that the company may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older."

But where Wood and other proponents of expanded over-the-counter access to Plan B saw a positive step, opponents used the announcement as an opportunity to air their concerns over increased availability of the pill.

"This decision is driven by politics, not by what is [good for] minors," said Wendy Wright, president of the conservative public policy group Concerned Women for America. "Now the FDA is making the drug available to minors, without parental consent. Parents should be furious with the FDA."