FDA debates lifting prescription requirement for morning-after pill


Tuesday, December 16th 2003, 12:00 am
By: News On 6


WASHINGTON (AP) _ Medical and women's groups are asking the government to allow a morning-after pill to sell without a prescription, saying easier access could prevent more than a million unplanned pregnancies and hundreds of thousands of abortions every year.

The Food and Drug Administration says emergency contraception is very safe, having been used by 2.4 million American women and millions abroad with few side effects.

The question the FDA poses to its scientific advisers Tuesday is whether women will understand how and when to take emergency contraception without professional advice.

Using the drug within three days of unprotected sex can greatly reduce the chance of getting pregnant; the sooner it's used, the more effective it is. Proponents of nonprescription sales say it's hard to find a doctor to write a prescription in time, especially on weekends and holidays, and that's if women even know the morning-after pill is available.

Two brands of emergency contraception are sold in the United States; the maker of Plan B has asked that its version be sold over the counter.

If FDA's advisers back the move and the agency ultimately lifts the prescription requirement, the question would become whether morning-after pills would sit on shelves next to aspirin and other easily available products, or have to handed over by pharmacists upon request. That option would make advice available if desired.

Already, five states allow women to buy emergency contraception directly from certain pharmacists without prescriptions, so-called behind-the-counter sales. The programs are in Washington, California, Alaska, Hawaii and New Mexico.

Proponents want no restrictions on nonprescription sales.

``Putting safe, effective backup birth control on the drugstore shelves next to condoms will give many more women a second chance to prevent pregnancy,'' said Kirsten Moore of Reproductive Health Technologies Project. Her group coordinated a petition by more than 70 health and advocacy groups urging over-the-counter sales.

Morning-after pills are higher doses of the hormones in regular birth control pills. Taken soon after unprotected intercourse, they are from 75 percent to 89 percent effective at preventing pregnancy. The FDA says the pills should be used within 72 hours; some contraceptive advocates say women who miss that window can try them for up to five days.

Emergency contraception works by preventing ovulation or fertilization of an egg.

If fertilization already has occurred, it prevents the egg from implanting into the uterus, the medical definition of pregnancy.

If a woman already had become pregnant, emergency contraception would have no effect. So it hasn't proved nearly as contentious as RU-486, the abortion pill.

Emergency contraception does have opponents, however _ groups such as the anti-abortion Concerned Women for America that oppose any interference with a fertilized egg. Critics contend if regular birth control pills are too risky for nonprescription use, then they are for emergency use as well. They also worry that broader access to emergency contraception could increase sexually transmitted diseases.

Proponents argue there's no evidence that access to emergency contraception makes women more careless about regular birth control.

Studies of nonprescription emergency contraception found that 68 percent of women used the pills correctly, and the step that tripped up some _ knowing to take the second dose 12 hours after the first _ could be clarified better in the label, FDA reviewers concluded.