Groups push to obtain OTC status for Plan B.(News)

ROCKVILLE, MD. -- A coalition of women's groups recently called for the Food and Drug Administration to approve over-the-counter marketing status for the emergency contraceptive Plan B (levonorgestrel).

Waving banners and colorful signs, member organizations of the "Morning After Pill Conspiracy" congregated outside FDA headquarters to protest the agency's prior rejection of over-the-counter sales of Plan B.

The protest resulted in at least a dozen arrests of individuals who blocked FDA's main doorways, demanding a meeting with Steven Galson, M.D., acting director of the FDA's Center for Drug Evaluation and Research (CDER).

Counter to the recommendation of two FDA advisory committees, Dr. Galson rejected Barr Laboratories' initial request for over-the-counter marketing status last spring, citing a lack of sufficient evidence regarding the effects of OTC availability of emergency contraception in younger women.

At press time, the FDA was considering a second application for OTC status for Plan B. According to a spokeswoman from Barr Pharmaceuticals, FDA was expected to issue a decision by Jan. 20, under an action of the Prescription Drug User Fee Act.

Coalition leaders rejected an alternative offer by FDA officials to take five members of the group into the building to meet with CDER's director, Janet Woodcock, M.D.

"FDA's decision affected more than just five women," said Stephanie Seguin of Gainesville (Fla.) Women's Liberation, one of the protesters. Other groups represented at the event included the National Organization for Women and the New York Reproductive Rights Task Force.