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A Big Change in How Women Get the Pill? : Health: Some family-planning experts and drug makers want oral contraceptives to be sold over the counter. Opponents fear the change would keep women from getting gynecological checkups.


During the past few years, a growing number of drugs have moved from prescription to over-the-counter status: ibuprofen, hydrocortisone cream, vaginal yeast preparations and some ulcer remedies, to name a few.

Most made the switch without controversy. Now, however, the stage is set for what may be a contentious application for the transition of oral contraceptives.

And the debate has begun.

Drug manufacturers and some health experts say they plan to request a meeting with Food and Drug Administration officials later this year to discuss the issue. A switch of oral contraceptives to over-the-counter, or OTC, status could be accomplished in as little as three to five years, one proponent predicts. Major supporters, among them some drug manufacturers and family-planning professionals, say benefits far outweigh possible costs, noting that more than 30 years of use has shown the Pill to be extraordinarily safe. And, if improved instructions are included in the packaging, they say, women will use the drug correctly.

But opponents, including some physicians and consumer organizations, say the Pill poses too many dangers to be sold over the counter, especially to women at risk for complications because of high blood pressure and diabetes.

Further, they criticize any move that would sever some women's only connection to regular gynecological care. Many young women, they say, seek health care only when they want a prescription for the Pill. And poor women, who receive the drug at little or no cost, might have to pay for it over the counter.

Oral contraceptives can be obtained only with a prescription. And, under federal labeling guidelines, clinicians may not prescribe the pills without first taking a medical history and performing a pelvic examination and any needed blood tests for sexually transmitted diseases.

Obtaining the contraceptives without such procedures would represent a stunning change in the control of a woman's reproductive health, experts on both sides acknowledge.

"It would be a godsend for some women. To be freed from the expense and trouble of obtaining a prescription would be a tremendous convenience," says Dr. Michael Rosenberg, president of Health Decisions Inc., a North Carolina-based research consulting firm. "And most people feel the medication is quite safe. The real question is about the secondary impact this might have, such as (disrupting) the access a young woman has to the medical system."

Oral contraceptives have become a candidate for non-prescription status for several reasons:

* Increasingly, the FDA is allowing drugs to switch to OTC status. About 50--such as some smoking deterrents, anti-arthritic drugs and medications to control blood pressure and lower cholesterol--are expected to switch in the next few years.

* Oral contraceptives are among the most thoroughly evaluated drugs ever and have a proven safety record if used appropriately.

* The high rate of teen-age pregnancies has prompted health officials to seek ways to improve the accessibility of the Pill to younger women. The Pill is the most popular form of contraceptive among females ages 15 to 29, and almost half of sexually active teens ages 15 to 19 rely on it.


While many distrusted oral contraceptives when they were introduced in 1960, studies have been generally reassuring of the Pill's safety. For example, cardiovascular disease is not related to use of a low-dose Pill, experts say, a risk associated with the early higher-dose Pill. (A low-dose Pill refers to the amount of hormones present.) And a fear that the drug may increase the risk of breast cancer has not been proven.

Moreover, oral contraceptives have been shown to confer many health benefits, such as protection against endometrial and ovarian cancer. However, women with high blood pressure, diabetes and those over age 35 who smoke are advised not to take the Pill because of possible complications. Women with high blood pressure, a history of stroke or heart attack or smokers over 35 may be at increased risk of a heart attack or blood clots by taking oral contraceptives. And in some diabetic women, higher doses of oral contraceptives can affect blood-sugar metabolism.

"The lower-dose oral contraceptives are very well (tested) for safety. The question is whether this drug could be used effectively," says Carol R. Scheman, FDA deputy commissioner for external affairs. "The question the agency will ask is, 'Is this a drug that can be taken safely and effectively by a consumer in an over-the-counter setting? Are there directions for use that can be understood by the consumer in this setting?"

Scheman says the agency will look hard at all sides of the issue. A meeting scheduled earlier this year on the topic was canceled when top FDA officials feared a cross-section of viewpoints would not be included. But some experts predict the FDA will eventually approve the switch to non-prescription status once pharmaceutical companies apply.

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