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.