FDA OKs nonprescription ‘morning-after’ pill

updated 7:39 p.m. ET Aug. 24, 2006

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.

Controversy over age restriction
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.

The age restriction remains controversial even inside FDA, agency drugs chief Dr. Steven Galson told The Associated Press Thursday. Galson has acknowledged overruling his staff scientists’ opinion in 2004 that nonprescription sales would be safe for all ages.

“Let me be frank, there still are disagreements,” Galson said in an interview. “There were disagreements from the first second this application came in the house.”

But, “I’m convinced adolescents are a different group, they require special analyses, sometimes special data,” he added.

As a condition of approval, Barr agreed to track whether pharmacists are enforcing the age restriction, by, among other things, sending anonymous shoppers to buy Plan B. FDA said Barr is to conduct that formal tracking at least twice in the first year of sales and annually thereafter, and report stores that break the rules to their state pharmacy licensing boards.

But Barr also will conduct a national education campaign to raise awareness of emergency contraception, among both women and health providers.

The two-pill pack of Plan B today costs from $25 to $40; Barr hasn’t said if it will raise the price. Planned Parenthood, already a main dispenser of the pills, expects some insurers to continue covering prescription sales for those who seek the drug that way. But which way is cheaper depends on a woman’s insurance.

A Barr spokeswoman estimated that pharmacists dispense about 1.5 million packs a year.

Nine states — Washington, California, New Mexico, Alaska, Hawaii, Maine, New Hampshire, Massachusetts and Vermont — already allow women of any age to buy Plan B without a doctor’s prescription from certain pharmacies. Proponents of those pharmacy access programs believe that minors won’t see any change in those states, because the pharmacist already technically writes a prescription.

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