Open sale urged for morning- after pill

FDA advisory panels recommend contraceptive be sold over-the-counter

Only for emergency, backup use

December 17, 2003|By NEW YORK TIMES NEWS SERVICE

GAITHERSBURG - 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, 23-4, 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 over 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, chairman of the board of Women's Capital Corp., the company organized by activists from non-profit 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.

Prevent abortions

Women's health advocates say wider use of the drug, should it become available without a prescription, could help 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.

Widely used overseas

Panelists who supported the switch to over-the-counter said they believed the drug had been proved safe in years of use in the United States and in 100 other countries. In 33 countries it is sold without a prescription.

In addition, they said, a company study of the effects of non-prescription sales showed 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 teen-agers, 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, Texas.

"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 worried that the drugs would be used as first-line contraception by women, rather than as a backup when other methods fail.

Even those on the panels who supported making the drug available over-the-counter wanted changes in the way the pills are labeled for consumers.

Some said they wanted the company to remove language that says the pills do not cause abortion.

Instead, they want it to spell out that the pills, which contain the hormone progestin, largely work by preventing ovulation but might also interfere with fertilization and with 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 about whether to use the drug.

In addition, many wanted the label to be very clear that the drug was to be used as back-up contraception only and that it needed to be taken immediately after unprotected sex.

Their concerns arose from some studies that found repeated use of the pills by some women in other countries and confusion among some U.S. women about when to take the pills.

Some also wanted a clearer warning about the risks of ectopic pregnancy, a potentially fatal condition in which a fertilized egg becomes lodged in the fallopian tube, although company and FDA officials said the risks were no higher than among the population overall.

The panelists discussed, but ruled out, limiting the availability of the drug for young women.

Many panelists asked the FDA to consider requiring the company to conduct follow-up studies if the drug is approved, looking at whether women begin using the drug as their main method of contraception.

Although it has been used in that way by women in other countries without safety problems, panel members said that would present a problem because it does not protect women against sexually transmitted diseases the way a condom does.

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