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Sell next-day pill over the counter, FDA panels say

GAITHERSBURG, Md. -- The morning-after pill should be sold over the counter without any requirement that women see a doctor first, two scientific panels advised the Food and Drug Administration yesterday.

The advisers voted, 23 to 4, to recommend that the FDA allow the sale of Plan B, the leading emergency contraceptive pill, without a prescription to make the medicine more available to millions of women who want to prevent unwanted pregnancies. The FDA, which normally follows the recommendations of its advisers, is expected to make a final decision by mid-February, said Dr. Sandra Kweder, deputy director of the agency's Office of New Drugs.

Some panelists and members of the public who testified before the committees yesterday suggested that politics on sexuality and abortion were shaping the decisions, but Kweder said, "This is a decision that will be based on science."

Plan B is used by about 1.2 million American women each year, but doctors and women's health advocates testified during yesterday's meeting that the requirement for a prescription was hindering women's access after unprotected sex, contraceptive failure, or rape. The drugs are 89 percent effective if taken within 72 hours of sexual intercourse.

"It's a historic day for women and a fantastic validation of the women's health movement," said Ellen Chesler, chairwoman of the board of Women's Capital Corp., the company organized by activists from nonprofit women's groups to bring the emergency contraceptive to market in 1999. Women's Capital Corp. is in the process of selling the drug to Barr Laboratories in the hope of broadening its availability through Barr's large sales force and marketing muscle.

Women's health advocates say wider availability of the drug could prevent as many as 1.5 million unintended pregnancies a year and as many as 700,000 abortions.

If the FDA approves over-the-counter sales, the drug could be available in any store. But Barr officials said they have committed to selling it only to stores with a valid pharmacy license or drug wholesale license.

"It wouldn't be available in convenience stores or vending machines," said Carole Ben-Maimon, president of Barr Research, the arm of the company that sells brand-name drugs.

Ben-Maimon said the company has not set a price for the pills over the counter, but Plan B currently sells for about $25 to $30 at retail pharmacies for a two-pill dose.

Panelists who supported the switch to over-the-counter sales said they believed the drug had been proved safe in years of use in the United States and in 100 other countries. It is sold without a prescription in 33 countries. In addition, they said, a company study of the effects of nonprescription sales indicated that most women understood the purpose and use of the drug without a doctor's involvement.

But others among the doctors, pharmacists, researchers, and consumer representatives on the panels, which advise on over-the-counter drugs and reproductive health, said women, particularly teenagers, needed the advice of a physician.

"If you remove the need for a patient to talk to me, you remove my ability to help them," said Dr. Susan Crockett, director of maternity services at CHRISTUS Santa Rosa in San Antonio. "I believe this company is well intentioned in seeking to reduce abortions, but I am concerned there will be an exploitation of young women's fears about pregnancy." She and others expressed concern that the drugs would be used as first-line contraception.

Even those on the panels who supported making the drug available over the counter wanted changes in the way the pills are labeled. Some wanted the company to remove language that says the pills do not cause abortions. Instead, they want it to spell out that the pills, comprising the hormone progestin, largely work by preventing ovulation and may also interfere with fertilization and with the implantation of a fertilized egg in the uterine wall. They said that would allow women who believe life begins at fertilization to make an informed choice.

In addition, many wanted the label to be very clear that the drug was to be used only as backup contraception and that it needed to be taken immediately after unprotected sex. Studies have found repeated use of the pills by some women in other countries and confusion among some US women about when to take them. Some panelists also wanted a clearer warning about the risks of ectopic pregnancy, a potentially fatal condition in which a fertilized egg becomes lodged in a fallopian tube, although company and FDA officials said the risks were no higher than among the population overall.

During the daylong hearing, panelists heard presentations from Barr and the FDA about the drug's use and about its safety record. In addition, the panelists heard 90 minutes of impassioned testimony from 42 members of the public. Supporters of the move included the American College of Obstetricians and Gynecologists, the National Organization for Women, and the Boston-based Our Bodies, Our Selves collective, which said many women have been unable to obtain the drug because they cannot afford a visit to the doctor or cannot find a pharmacy that stocks the drug. Opponents included representatives of the Catholic Medical Association, who said bypassing doctors would be "disastrous" for teens who needed medical advice to learn about the risks of sexual intercourse, and the American Pharmacists Association, who said women need the advice on how to take the pills properly.

Hillary Flowers, a 23-year-old member of NOW from New York City, said she had to call 20 doctors and then pay $200 for an office visit to get a prescription for Plan B after a condom broke during sex with her boyfriend. When she faced a second contraceptive failure awhile later, she said, she couldn't afford the time or the expense, so she took a handful of left-over birth control pills in the hope they would work, but not make her horribly ill.

"I shouldn't have to risk my life because I couldn't afford $200," she said. She did not become pregnant.

State Representative Robert Marshall of Virginia told the panel that "playboys and adolescent males would be the major beneficiaries" of a move to over-the-counter status, because they would buy the drug to encourage women to have sex with them.

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