In a surprise move, the Food and Drug Administration postponed for at least 60 days a final decision on how to allow nonprescription sales of the morning-after pill called Plan B just to women 17 or older.
"Enforceability is the key question," said FDA Commissioner Lester Crawford.
The drug's maker, Barr Pharmaceuticals, criticized the decision, questioning how the agency could acknowledge that scientific evidence supported nonprescription sales and yet not allow those sales to begin.
"It's like being in purgatory," said Barr chief executive Bruce Downey.
The morning-after pill is a high dose of regular birth control that, taken within 72 hours of unprotected sex, can lower the risk of pregnancy by up to 89 percent.
It was Barr's latest disappointment in the two-year battle to sell Plan B without a prescription. Contraceptive advocates and doctors groups say easier access could halve the nation's 3 million annual unintended pregnancies. FDA's scientists say the pills are safe, used by more than 2.4 million Americans and millions more women abroad with few side effects.
The agency's independent scientific advisers overwhelmingly backed over-the-counter sales for everybody, not just adults, in December 2003.
FDA rejected that recommendation, citing concern about young teens' use of the pills without a doctor's guidance. Barr reapplied, asking that women 16 and older be allowed to buy Plan B without a prescription while younger teens continue to get a doctor's note. Downey said the company thought it had satisfied all of FDA's scientific and legal concerns about how to do that — noting that cigarettes are sold in drugstores with age restrictions.
Friday, FDA essentially boiled the issue down to regulatory precedent: Selling the same dose of a drug by prescription and without at the same time and for the same medical use has never been done. The FDA will allow 60 days of public comment on how to take such a step and enforce an age limit, but Crawford would not say how soon the agency could evaluate those comments and rule.
Why an age restriction at all? Crawford said the issue was at what age teens can understand how to use the pills properly.
Contraceptive advocates had expected a final decision by a Sept. 1 deadline that Crawford had pledged to members of Congress as a condition of assuming leadership of FDA.
"I am disappointed that FDA waited until this late hour to address a legal question that could and should have been resolved months ago," said Sen. Edward Kennedy, D-Mass. "I urge FDA to act quickly to approve this needed reproductive option for women."
"It seems improbable to me that ... politics hasn't trumped science here, which is a tragedy," said Dr. Alastair Wood of Vanderbilt University, a member of the FDA advisory committee that evaluated Plan B.
"They are acting in bad faith," said Kirsten Moore of the Reproductive Health Technologies Project, noting that FDA already has logged 17,400 letters from the public and advocacy groups urging it to take one side or the other on Plan B. "How many more comments do they need?"
Crawford broke a personal pledge to Congress to decide Plan B's fate by Sept. 1, charged two senators who called for congressional hearings into the delay.
"It is a breach of faith," Sens. Patty Murray, D-Wash., and Hillary Rodham Clinton, D-N.Y., who lifted objections to Crawford assuming leadership of FDA only after his pledge, wrote in a statement. "There is no credible scientific reason to continue to deny increased access to this safe health care option."
Conservative groups, which have intensely lobbied FDA arguing that over-the-counter emergency contraception would encourage teen sex, welcomed the agency's decision.
"It is naive to assume any over-the-counter scheme for the morning-after pill would be effective," said Wendy Wright of Concerned Women for America. "Making the morning-after pill over-the-counter would only benefit those that profit from its increased sale, but the real price will be paid by women and girls who would suffer the health consequences."
If a woman already is pregnant, the pills have no effect. They prevent ovulation or fertilization of an egg. They also may prevent the egg from implanting into the uterus, the medical definition of pregnancy, although recent research suggests that's not likely.
Laws in seven states — Alaska, California, Hawaii, Maine, New Hampshire, New Mexico and Washington — already allow women to buy Plan B without a prescription, with no age restrictions. Massachusetts is set to become the eighth this fall, as lawmakers are expected to override their governor's veto of nonprescription sales.