WASHINGTON — The Food and Drug Administration, in a surprise move that angered religious conservatives, offered a proposal Monday to allow the "morning-after" birth control pill to be sold without a prescription to women age 18 and older.
It marked a potentially significant step toward breaking the stalemate between people who worry that unrestricted access to the pill could encourage promiscuity, and people -- including the FDA's medical staff -- who say scientific evidence shows the drug is safe.
The proposal came in a letter from the FDA to Barr Pharmaceuticals Inc., manufacturer of the pill known as Plan B. Barr was asked to describe the steps it would take to prevent sales to customers younger than 18 if the agency approved over-the-counter sales for adults. The FDA said it wanted to make a final decision on distribution in a matter of weeks.
Plan B allows women to prevent pregnancy by taking a high dose of a conventional contraceptive hormone up to 72 hours after unprotected sex.
California and seven other states have circumvented the FDA by using their regulatory powers over pharmacies to make Plan B available without a prescription.
The letter, signed by acting FDA Commissioner Andrew C. von Eschenbach, was seen by some as a signal that the Bush administration was prepared to move forward with approval as recommended by its scientific staff more than two years ago.
FDA officials seem "inclined to approve it," said economist John E. Calfee, who follows the drug industry for the American Enterprise Institute, a business-oriented think tank. "They just want [the manufacturer] to say the right things about how they are going to monitor the use of the drug."
But critics, led by religious conservatives, made clear they had no intention of relaxing their opposition to wider release of Plan B.
"The FDA cannot find time to withdraw the dangerous abortion pill RU-486 from the market no matter how many women die after taking it, but now the rogue agency is willing to reopen debate on whether to remove medical care from the morning-after pill," Concerned Women for America, a conservative Christian organization, said in a press release. "The prescription process protects women's health."
The FDA is investigating the cases of several women who used RU-486 and died from a rare type of infection.
Plan B is classified as a contraceptive, not an abortion drug like RU-486, which is taken to end an established pregnancy.
