FDA approval of abortion pill linked to stringent conditions

June 7, 2000
Web posted at: 3:40 p.m. EDT (1940 GMT)

From staff and wire reports

ATLANTA -- Officials of the U.S. Food and Drug Administration plan to link approval of a controversial abortion pill to restrictions that could limit its availability to American women, according to Planned Parenthood of America.

President Gloria Feldt said, "We are deeply concerned that FDA is considering restrictions that in my view would virtually assure that very few doctors would ever make mifepristone available."

Mifepristone, also known as RU-486, is the principal ingredient in the abortion pill, developed during the 1980s in France. The pill is far less invasive than a surgical abortion and can be given in a physician's office. It has been widely used in Europe since 1988 for early-term abortions.

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Anti-abortion groups in the United States oppose its approval.

In February, FDA officials said approval of RU-486 sales would be granted but with restrictions, which were not then identified.

Conditions proposed

Feldt said the most pressing concern is an FDA proposal that physicians allowed to administer RU-486 must be part of a national registry. Such a list, she said, would deter doctors worried about anti-abortion violence from offering the pill.

Another proposal would limit the drug to those doctors who are qualified to perform surgical abortions, in case the medication does not cause a complete abortion. The doctors also would be required to hold admitting privileges to a hospital within an hour's drive of their offices.

Dr. Mitchell Creinin of the University of Pittsburgh, who has done extensive studies on mifepristone, said "The FDA is creating a whole new standard with these restrictions." He said the proposals amount to supervision of medical care.

Feldt said the FDA also is considering long-term health tracking of at least some RU-486 recipients. Such follow-up studies are common after a new drug is approved. But Feldt said such study is unnecessary because of the drug's track record in Europe.

Mifepristone, a synthetic steroid, interferes with a fertilized egg's adhering to the lining of the uterus. To cause an abortion, it is used early in pregnancy with another drug, misoprostol, which prompts uterine contractions.

Studies show RU-486 is 95.5 percent effective in causing abortion when taken within the first seven weeks of pregnancy. A very small percentage of patients require additional surgical treatment or blood transfusions. FDA officials are considering those factors, and how to ensure that women return for a follow-up visit to make sure the pill was effective.

Surgical abortions performed in the first trimester are more than 99 percent effective.

A spokesman for the National Right to Life Committee said that while his organization continues to oppose mifepristone, the proposed restrictions are appropriate because the drug can be dangerous for women.

FDA officials have not commented.

Lengthy approval process

The nonprofit Population Council received U.S. marketing rights to RU-486 in 1994. The original French manufacturer, Roussel-Uclaf donated the rights out of fear for an anti-abortion boycott.

"Clinical trials conducted by the council found the two-drug combination of mifepristone and misoprostol to be safe, effective and highly acceptable to American women," the Population Council said.

Sandra Waldman, speaking for the Population Council, emphasized that FDA discussions over the pill's use have just begun and no conditions have been made final.

She said FDA officials have until September 30 to respond to the mifepristone application.

RU-486 differs from the "morning-after pill," approved by the FDA in 1998. According to Planned Parenthood, the morning-after pill is an "emergency contraception (that) can prevent pregnancy up to 72 hours after unprotected intercourse. Widespread use of emergency contraception could cut the rates of unintended pregnancy and abortion by as much as half."

CNN Medical Correspondent Rhonda Rowland, The Associated Press and Reuters contributed to this report.

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Food and Drug Administration
Population Council
Planned Parenthood Federation of America
New England Journal of Medicine
Archives of Family Medicine
The RU-486 Files
Life Issues: RU-486 Report
FMF -- Feminist Majority RU486 Campaign

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