No prescription for the Pill?

FDA considers making pill available over-the-counter

From staff reports

Forty years ago, "the Pill" helped to begin a tectonic shift in Americans attitude about birth control. But while consumers in other countries such as Japan and the Philippines can buy birth control pills off the pharmacy shelf, women in the United States still need a doctor’s prescription.

The Food and Drug Administration is continuing to discuss relaxing prescription-only restrictions on a number of medications, including birth control pills, during hearings today in Washington, D.C. The hearings began Wednesday.

"We are concerned that products available in the over-the-counter market have a very strong track record for safety," said Dr. Robert DeLap of the FDA.

VIDEO CNN's Holly Firfer examines the pros and cons of selling oral contraceptives over the counter Real 28K 80K Windows Media 28K 80K

The Pill: Quick Facts There are about 60 million women of childbearing age (15-44) in the U.S. The Pill has been the subject of more than 73,000 publications and scientific reviews during its history. More than 16 million American women currently use the Pill. Eight out of 10 women in the U.S. have used the birth control pill at some point in their lives. Four out of 10 American women between the ages of 18 to 29 currently take the Pill. Source: Ortho-McNeil Pharmaceuticals

Gynecologist Robert Hatcher of Emory University has been studying the pill since its development, and says its history has shown it to be perfectly safe for use over the counter. "Women should have greater access to them," he said. "They could get them privately, without going through a formal medical care system, which can be embarrassing and costly."

Some women are going beyond the pill’s traditional use, as well. British medical journal The Lancet recently noted that some women are avoiding monthly periods and premenstrual syndrome by taking birth-control pills every day.

About 10 percent of Emory Clinic gynecologist Charles Wootten’s patients who take the pill continue to use the contraceptive during the whole monthly cycle, he estimated.

Still, Dr. Wootten recommends that women discuss the matter with their physicians. Often, his patients will take the pill continuously for three months, then have a break.

While the pill is about 99 percent effective in preventing pregnancy when taken correctly, a lot of women still believe there are substantial risks associated with its use. According to a Gallup poll conducted for the American College of Obstetricians and Gynecologists, 41 percent of the women surveyed held this view.

Most side effects of oral contraceptive use are not serious. But some of the more serious risks include possibly life threatening blood clots, stroke and heart attacks. These risks increase with cigarette smoking - especially over age 35.

Pill user Whitney Perkins said her doctor has discussed the risks with her, as well as other side effects. "If you take antibiotics on the birth control pill, they are less effective," she said. Also, there can be "dryness and weight gain."

Some fear that over-the-counter availability will increase the risk of serious side effects because women may not see a doctor regularly enough to receive adequate information or to have routine exams or Pap smears.

"It would be up to us at that point to come up with much better information in our package inserts to provide people information on what to watch out for about oral contraceptives," said Hatcher. "Pregnancy is seven times more dangerous than pills, smoking is 50 times more dangerous than pills, driving is 12 times more dangerous than pills. I mean, there are lots of drugs, there are lots of habits that people have that are much more dangerous than pills, and pills also prevent ovarian and endometrial cancer and have a lot of benefits with regard to other women’s health issues."

There also are economic considerations. The average cost of a month’s supply of the pill ranges from $25 to $30 by prescription, or nearly $400 a year. Consumers would benefit from plummeting prices if the drug were available over-the-counter, but pharmaceutical companies would lose profits, and fewer visits to doctors’ offices would mean less revenue for them as well.

Objections filed thus far with the FDA to providing birth-control pills over-the-counter by the public mostly focus on moral grounds, questioning the wisdom of making them freely available to teenagers.

CNN Medical Correspondent Holly Firfer contributed to this report.

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