FDA PANEL RECOMMENDS U.S. APPROVAL OF ABORTION DRUG.

Byline: Shankar Vedantam Knight-Ridder Newspapers

American women likely will have access to an abortion pill by early next year.

After a hearing Friday that showcased the strong feelings the abortion issue arouses, a scientific advisory committee of the Food and Drug Administration recommended that the pill, RU-486, be approved in this country. The committee found it safe and effective for general use.

The vote was six in favor, with two abstentions.

The FDA has promised to reach a decision on whether to approve the drug - already available in France, England and Sweden - by September. While the agency is not bound to follow the advice of the advisory panel, it usually does.

The pill, which was approved for women who have been pregnant less than seven weeks, promises an alternative to surgical abortion. It is to be administered only in clinics under direct medical supervision and will not be sold in pharmacies.

In the United States, where about 1.5 million abortions are performed each year, abortion opponents have fought the introduction of the drug, also known as mifepristone, for years.

``This is potentially a historic time for American women,'' Gloria Feldt, president of the Planned Parenthood Federation of America, said in an interview. ``It enables a woman to terminate a pregnancy earlier and without surgery and without anesthesia.''

Critics of the drug fear that the pill will be used for ``emergency contraception'' and lead to greater sexual irresponsibility.

The pill also has side effects, as detailed in reports on use of the pill by hundreds of thousands of European women and preliminary data from a study of 2,121 Americans.

The studies predicted painful uterine contractions in four out of every five women, nausea in half the women, vomiting and diarrhea in about one in five. Almost all women using the pill bleed, on an average for nine days. One in a hundred women in the U.S. trials had to be hospitalized following the procedure.

If the FDA follows its timetable, it will make its decision on the increased availability of abortion within weeks of a presidential election in which abortion issues are expected to play a key part.

Asked whether that would affect his action, Dr. David Kessler, FDA commissioner, said, ``Not at all.''

Beneath the billing of calm science at the meeting, emotions around the abortion debate surged. Armed guards patrolled outside the conference hall, and police cruisers guarded the road leading to the FDA Technical Center. Metal detectors scanned hand baggage and screened those attending.

``Pregnancy is not a disease, and a baby is not a tumor,'' said Rebecca Lindstedt, a spokeswoman for the American Life League. Her colleagues in the anti-abortion movement huddled under umbrellas outside the center and waved placards.

The Population Council, a nonprofit research organization based in New York, has patent rights for the drug in the United States. It estimates that a patient's cost for the abortion, including follow-up visits, will be around $200 - about the lower-end cost for a surgical abortion.

Abortion opponents fear that many doctors who currently do not perform surgical abortions might be willing to administer the pill if it were available, which in turn may drive up the number of annual abortions.

Scientists at the meeting said the number of ob-gyns who currently provide abortion services - one in every three - may rise by as much as 66 percent if the pill is approved.

Abortion-rights groups feel that the pill will provide women with an alternative that offers them greater privacy and control. The pill can be used as soon as a woman knows she is pregnant.

``With surgical abortion you can't get an abortion until six to seven weeks'' after conception, said Susan Dudley, a spokeswoman at the National Abortion Federation, the association of North American abortion providers.

``Some women know right away it's not a pregnancy they want to continue,'' she said. ``With this method they won't have a delay.''

Studies from France also did not show that the overall number of abortions went up with the availability of the pill, she said.

``I would not regard it as being easier than the surgical procedure,'' said Feldt. ``They are both traumatic and take time. It's not something you would do for fun.''

Pill advocates also argue that the abortion pill will make it harder for abortion opponents to target protests at abortion centers.

``Mifepristone will allow physicians greater privacy, making it more difficult for those who oppose abortion to harass them and their patients,'' said Allan Rosenfield, a spokesman for the American Public Health Association.

Pregnant women who opt for the procedure are administered mifepristone on their first doctor's visit. The drug mimics a natural hormone, progesterone, that is crucial to the development of the fetus.

``It binds to the progesterone receptor and then progesterone can't get on and can't produce progesterone action,'' said Daniel Mishell, chief of Obstetrics and Gynecology at the University of California, Los Angeles.

The pill also encourages uterine contractions, which may expel the fetus, but most women need to come in for a second doctor's visit within 48 hours to take another drug called a prostaglandin. This triggers expulsion of the fetus, usually within 24 hours, in almost all women.

``It's equivalent to a spontaneous miscarriage, except that it is quicker,'' said Elizabeth Newhall, an abortion provider in Portland, Ore., and one of Population Council's presenters to the FDA.

A third follow-up visit in a couple of weeks makes sure the patient is doing well. In the few cases where the fetus has not been aborted, a surgical abortion is performed.

Women who do not show up for the second or third visit, however, may suffer serious health risks. The FDA, the critics charged, has no way of ensuring patient compliance.

Quoting examples from Europe where women did not show up for the second or third visit, Rep. Tom Coburn, R-Okla., who is an obstetrician, said in a message to the advisory committee that there was ``no reason to believe compliance in the U.S. will be any better than it is overseas.''

The Population Council said that almost 200,000 women have used the drug in Europe since the late 1980s. While extreme side effects were extremely rare, they included heart problems, heavy bleeding and the failure of the abortion process followed by birth deformities in babies.

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Photo

Photo: FDA advisory committee member Mary Pendergast and FD A Commissioner David Kessler listen to public testimony Friday.

Associated Press