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FDA Panel Calls for OK of Abortion Pill

July 20, 1996|SHERYL STOLBERG | TIMES STAFF WRITER

GAITHERSBURG, Md. — Clearing a path for revolutionary changes in the way American women undergo abortions, a federal advisory committee Friday recommended that the Food and Drug Administration approve RU-486, the controversial French abortion pill, for use in the United States.

An overwhelming majority of the eight-member panel endorsed the decision that the drug is safe and effective and that its benefits outweigh its risks. Although the recommendation is not binding, the FDA generally heeds the advice of its committees.

FDA Commissioner Dr. David A. Kessler said that the committee had sent "a very strong signal" that the drug, known as mefipristone in this country, should be approved. Kessler said the agency could take action as early as this fall.

The committee, however, did not act without caveats. It said it wants to see final safety data from an American study of 2,121 women who have taken the drug. Friday's recommendation rested on statistics from French studies and preliminary results of the U.S. testing.

The decision came after a contentious all-day hearing that pitted abortion foes--one of whom called the pill "a human pesticide"--against women's health advocates, who complained that approval had been delayed for years by antiabortion politics.

"This is a milestone," an elated Eleanor Smeal, president of the Feminist Majority Foundation, said after the vote. "It will result in the reframing of the abortion debate."

Antiabortion activists, however, complained that the FDA is steamrollering the approval in time for the November election because President Clinton has openly supported the drug. "The FDA approval process is moving at an unheard-of pace to approve this deadly drug . . , leaving many concerns about safety unresolved," said Wanda Franz, president of the National Right to Life Committee.

If it is approved, mefipristone promises to radically redraw the nation's reproductive map. Currently, a woman must wait until she is six weeks pregnant for a surgical abortion. With mefipristone--or "medical abortion," as it is called--she could terminate her pregnancy much sooner.

Moreover, advocates predicted that doctors who do not perform surgical abortions will offer the pill to their patients, making abortion more accessible and more private. That, in turn, would make it tougher for abortion foes to target doctors and clinics.

"It just makes it a much simpler process and a much less scary process," said Dr. Elizabeth Newhall, medical director of a Portland, Ore., clinic that participated in clinical testing of the drug.

The work was so controversial, she said, that while the tests were going on "we installed bulletproof glass and steel-gate doors in our clinic."

Against that backdrop, security at Friday's hearing was tight. Uniformed officers patrolled the entrances to the FDA's technical center, and meeting participants were ushered in through metal detectors. A few scattered protesters gathered outside in the early morning rain but were kept away from the meeting by a security checkpoint.

The application process was unusual. The request was brought by The Population Council, a nonprofit organization based in New York. The name of the manufacturer of the drug and the company that will distribute it if it is approved are being kept secret to shield the firms from attacks.

RU-486 was approved in France in 1988 but it has traveled a rocky road to the United States. In 1992, then-President Bush banned importation of the pill. The following year, in one of his first acts in the Oval Office, Clinton overturned the ban and ordered the Department of Health and Human Services to encourage testing and eventual sale of the drug.

Despite Clinton's order, the French manufacturer of RU-486 declined to market it here. But in 1994, the company, Roussel-Uclaf, donated its patent rights to The Population Council. The group quietly conducted the clinical trials in 17 states and filed a request four months ago for the FDA to approve the drug.

Essentially, mefipristone induces miscarriage. It works by blocking the hormone progesterone, which is vital to sustain pregnancy. Tests in France have found it to be 95.5% effective in terminating pregnancy when used in combination with another drug, and preliminary results in the United States show similar findings.

But contrary to popular belief, abortion with RU-486 is not as simple as popping a pill in the privacy of one's home. It would not be available at pharmacies. Only doctors would be able to administer it.

The procedure works this way: A pregnant woman would visit her doctor within 49 days of her last menstrual period. There, she would be given three 200-milligram tablets of mefipristone.

Two days later, the woman would return to the doctor's office for a second drug--misoprostol--which induces uterine contractions. She would remain for four hours for observation of possible adverse side effects, including excessive bleeding, nausea and cramping.

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