FDA allows some nonprescription sales of morning-after pill

Published: Thursday, Aug. 24 2006 12:06 p.m. MDT

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.

Talking to reporters Thursday aboard Air Force One as Bush headed to Kennebunkport, Maine, White House spokeswoman Dana Perino, asked for his reaction, said Bush "appreciates that the FDA did an exhaustive review, that they recognized the critical distinction between minors and adults and the risks a drug like this could pose."

Noting the restrictions the agency attached to its approval, Perino added, "I'm sure the FDA will follow through on that and make sure these important conditions are established and enforced."

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.

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