Sale of morning-after pill delayed

FDA postpones decision on non-prescription use

February 14, 2004|By NEW YORK TIMES NEWS SERVICE

The Food and Drug Administration told Barr Laboratories, the marketer of a so-called morning-after pill, yesterday that it was delaying for 90 days its decision on whether to allow the drug to be sold over the counter.

The agency has asked the company for more information about the use of the emergency contraceptive, also known as Plan B, especially among teen-agers, according to the company. Plan B, to be taken when regular contraception fails or is skipped, has been available by prescription.

But opponents, including some members of Congress, have objected to the company's application to make it available over the counter, arguing that it would encourage promiscuity and risky sex.

And many religious groups, some against abortion, oppose expanded use of the pill because they believe it interferes with conception. It usually acts by preventing ovulation, but it can also prevent a fertilized egg from implanting.

Dr. Steven Galson, acting director of the Center for Drug Evaluation and Research at the FDA, said that while the agency cannot comment on a specific drug application, it not infrequently asks for more data and delays its decisions while it reviews those data.

"We can extend the goal date, and that's just what happened here," Galson said. And while the agency has been lobbied by passionate proponents and opponents of the application, "we make our decisions based solely on science," he emphasized.

The drug's advocates said they feared that the FDA was responding to pressure from conservative groups, which oppose making the drug readily available.

"This delay is a politically transparent roadblock," said Gloria Feldt, president of Planned Parenthood Federation of America.

Plan B, consisting of two high-dose birth control pills, is meant to be used within 72 hours of unprotected intercourse, and the sooner the better because its effectiveness wanes as the hours go by. If used within that time frame, it can reduce the chance of pregnancy by 89 percent.

Its advocates say that doctors often don't prescribe it ahead of time so women can have it on hand in an emergency. Women say they have trouble finding a doctor to prescribe it when they realize they need it, often on weekends, when doctors' offices and health clinics are closed. And drugstores, with little demand, do not stock it, so that even when women seek it out they often cannot get it.

The solution, the drug's advocates said, was to make it available over the counter. Extensive safety data indicated that it was not a health risk for women to buy it and take it on their own. On Dec. 16, two expert advisory committees to the FDA recommended in a 23-4 vote that the drug be sold over the counter.

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