FDA Eases Limits on Morning-After Pill

Dr. Andrew C. von Eschenbach, acting director of the Food and Drug Administration, speaks during a news conference at the National Press Club in Washington, Wednesday, July 12, 2006 to announce a new fixed-dose once-a-day pill, called Atripla, for the treatment of HIV-positive patients. (AP Photo/Haraz N. Ghanbari) (Haraz N. Ghanbari - AP)

WASHINGTON -- Women may buy the morning-after pill without a prescription _ but only with proof they're 18 or older, federal health officials decided Thursday. The Food and Drug Administration ruling culminated a contentious three-year effort to ease access to the emergency contraceptive.

Girls 17 and younger still will need a doctor's note to buy the pills, called Plan B, the FDA told manufacturer Barr Pharmaceuticals Inc.

The compromise decision is a partial victory for women's advocacy and medical groups which say eliminating sales restrictions could cut in half the nation's 3 million annual unplanned pregnancies. Opponents have argued that wider access could increase promiscuity.

The long delay had ensnared President Bush's nominee to head the FDA. On Thursday, two senators said they would lift their blockade, making confirmation of Dr. Andrew von Eschenbach as FDA's commissioner likely next month.

The pills are a concentrated dose of the same drug found in many regular birth-control pills. Taken within 72 hours of unprotected sex, a woman can lower the risk of pregnancy by up to 89 percent. If she already is pregnant, the pills have no effect.

The earlier it's taken, the more effective Plan B is. But it can be hard to find a doctor to write a prescription in time, especially on weekends and holidays. Hence the push to allow nonprescription sales.

Barr has said it hopes to begin nonprescription sales of Plan B by the end of the year. The pills will be sold only from behind the counter at pharmacies _ so the pharmacist can check photo identification _ but not at convenience stores or gas stations.

There isn't enough scientific evidence that young teens can safely use Plan B without a doctor's supervision, von Eschenbach said in a memo.

But Barr did prove that over-the-counter use is safe for older teens and adults _ and licensed pharmacies are used to checking for proof of age 18 before selling tobacco and certain other products, von Eschenbach wrote in explaining the agency's age cutoff.

"This approach should help ensure safe and effective use of the product," he concluded.

Plan B's maker was disappointed that FDA imposed the age restriction and pledged to continue working the agency to try to eliminate it.

"While we still feel that Plan B should be available to a broader age group without a prescription, we are pleased that the Agency has determined that Plan B is safe and effective for use by those 18 years of age and older as an over-the-counter product," said Bruce L. Downey, Barr's chairman.