FDA nears approval of abortion pill RU-486 appears safe, effective 'under close supervision,' it says

More information sought first

Abortion foes accuse agency of supporting 'a human pesticide'

September 19, 1996|By Lyle Denniston | Lyle Denniston,SUN NATIONAL STAFF

WASHINGTON -- After a quarter-century of research and a decade of controversy, the French abortion pill gained yesterday the federal government's conditional approval for ending pregnancies privately and without surgery.

Potentially moving most abortions out of clinics and away from the conflicts outside those facilities, the Food and Drug Administration said that RU-486 appears safe and effective "when used under close medical supervision" to induce abortions.

RU-486, an invention of a French scientist, is formally known as mifepristone. The drug has been used in other nations for abortions in the first few weeks of pregnancy.

The FDA said it told the Population Council, a New York-based family-planning research and policy group which plans to market the drug, that it was ready to give final approval to RU-486 but would not do so until it has more information on how the drug is made and how it will be labeled.

It is unclear how long that could take, but the council said it would "provide the FDA the outstanding information necessary for approval."

Population Council President Margaret Catley-Carlson said the drug would be available only with a doctor's prescription. Her organization has set up distribution channels to make RU-486 widely available once the FDA takes final action. RU-486 is expected to be covered by insurance plans and by programs serving poor patients, such as Medicaid, unless Congress were to make an exception.

The Henry J. Kaiser Family Foundation, in a study released last fall, reported that a third of obstetrician/gynecologists who do not perform surgical abortions said they would be likely to prescribe RU-486 if it is approved. Abortion-rights activists say that would be especially important in areas where there are few abortion clinics.

Operation Rescue, an anti-abortion group that has sought to blockade the clinics where most abortions have been performed, yesterday accused the FDA of supporting the use of "a human pesticide."

Randall Terry, Operation Rescue's founder, said, "The FDA is participating in the chemical assassination of innocent people."

Another anti-abortion group, the Family Research Council, asserted that RU-486 has harmful side effects that would multiply once the drug is in wide use.

RU-486 has never had FDA approval for widespread use in the United States. The drug has been available only for limited clinical trials, including a series done by the Population Council.

The council has been seeking FDA approval of RU-486 since March, culminating a years-long effort to get the French manufacturer to allow it to be made and used in the United States. That effort has been strenuously resisted by anti-abortion forces.

The FDA's action yesterday marked the second time that the agency has acted to make nonsurgical abortions available to American women. Recently, it cleared the way for Planned Parenthood clinics -- including one in Maryland -- to conduct trials of two drugs, developed for other uses, as techniques for inducing abortions. Those drugs have been on the market to treat cancer and ulcers.

Pub Date: 9/19/96

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