RX: "MORNING AFTER" PILLS

By LEON JAROFF

Eight out of 10 american women of childbearing age have taken the Pill to prevent pregnancy, yet most are unaware that the oral contraceptive has another use. In a somewhat higher dose, it can serve as a "morning after" drug to avoid pregnancy after unprotected sex.

That is hardly news in Europe, where for more than a decade millions of women have been using the Pill for that purpose. And it is hardly a secret to U.S. pharmaceutical companies. But drugmakers have been reluctant to market or label their products as emergency contraception pills in the U.S., fearing that it would subject them to lawsuits, protests or even boycotts.

Now the U.S. Food and Drug Administration has decided to take matters into its own hands. The agency plans to publish a notice in the Federal Register declaring that oral contraceptives can be used safely and effectively to avoid pregnancy as late as three days after intercourse. While the action falls short of formal FDA approval, which can be granted only when a manufacturer files an application, it gives unmistakable and official sanction to emergency use. "We're delighted," says Gloria Feldt, president of the Planned Parenthood Federation of America. "We've been using this procedure for many years in our clinics but were not able to publicize it" without FDA sanction.

The FDA's decision was based largely on testimony by James Trussell, director of the Office of Population Research at Princeton University, at a committee meeting late last month. Citing large-scale morning-after trials involving six different oral contraceptives, Trussell reported a 75% drop in the rate of pregnancies. Women in the trial were asked to take a set of two or four pills (depending on dosage), the first set within 72 hours of unprotected intercourse, the second dosage 12 hours after the first set. The result: only 2% of those who took emergency contraception became pregnant, compared with the 8% who normally conceive without such measures.

Still, the FDA's action is bound to be controversial. While medical authorities consider that pregnancy begins when a fertilized egg implants itself in the uterus, most right-to-life advocates insist that life begins when the egg is fertilized, before implantation, and denounce any subsequent intervention. Trussell points out, however, that postcoital use can work at any of four stages in the female reproductive cycle. It can prevent ovulation, fertilization of the egg or transportation of the egg to the uterus; it can also make the uterine lining inhospitable to implantation. In any individual, he says, there is no way to determine at which stage pregnancy is prevented.

Despite the FDA's tacit green light, drugmakers are not likely to apply for formal approval. Wyeth-Ayerst, the largest U.S. producer of oral contraceptives, has no plans to market such pills or even include emergency contraceptive instructions on its current products. The real problem, rather than any political fallout, says Wyeth spokeswoman Audrey Ashby, is the risk of getting bogged down in costly product-liability suits.

Planned Parenthood, however, was emboldened by the FDA decision. It will begin urging smaller pharmaceutical firms to package their pills specifically as emergency contraception. "The FDA has gone as far as they can go," says Feldt. "They're clearly inviting the manufacturers to repackage the Pill." Whether or not drug companies respond, the FDA's action ensures that millions of American women will soon be aware of an important new option.

--By Leon Jaroff. Reported by Christine Sadlowski/New York

With reporting by CHRISTINE SADLOWSKI/NEW YORK