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Going Over the Counter? Legislators to Debate Future of the Pill

By Ori Twersky
WebMD Health News

June 14, 2000 (Washington) -- About 18 million U.S. women each year visit a doctor to get a prescription for an oral contraceptive, better known as the pill. But if the FDA sides with supporters of the over-the-counter contraceptive pill, women may soon be able to go directly to the drugstore and bypass the office visit.

David Grimes, MD, and other supporters of making the pill available over the counter will soon have a unique opportunity to have their concerns heard. Officials with the FDA have scheduled a public hearing in late June to discuss whether the pill and certain other drugs should be available without a prescription. Among other things, the FDA says its main concerns are about the side effects and whether the pill can be used without the help of a doctor. Grimes is vice president of Family Health International, a nonprofit group focusing on reproductive health.

In his corner, Grimes enjoys the support of several strong allies. For example, Robert Hatcher, MD, MPH, is a professor of obstetrics and gynecology at Emory University School of Medicine. "I am strongly in favor of women being able to obtain oral contraceptives over the counter," says Hatcher, a co-author of Contraceptive Technology, a book widely regarded as the bible of birth control.

Despite this support, there still is no guarantee that the pill will make the cut. Among the potential barriers are concerns related to the pill's potential link to breast cancer and blood clots in the lungs.

Another issue supporting doctors' continued involvement in prescribing the pill is that birth control may fail when a woman starts taking an antibiotic. In fact, the American Medical Association recently adopted clinical practice recommendations that advise physicians to counsel women taking antibiotics that their contraceptives may not work.

The AMA recommendations note that "it is not possible to identify in advance the women who may be at risk of oral contraceptive failure." The AMA also recommends that doctors tell women that they may want to use non-hormonal contraceptives while they are on some antibiotics, especially if oral contraceptives have failed them in the past, or if the women develop "breakthrough bleeding" while taking the two drugs.

Kate Curtis, PhD, is an epidemiologist at the CDC, where investigators are looking into the pill's relationship to breast cancer. The results will not be out for another year, she tells WebMD. But there is a chance that the CDC-sponsored study of 10,000 women will find a relationship between the pill and breast cancer in certain groups of women, she says.

Still, none of the several experts contacted by WebMD would go on record with reasons the pill should not be available over the counter.

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