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'Abortion pill' moves towards U.S. approval

RU 486

September 16, 1996
Web posted at: 10:45 p.m. EDT

From Correspondent Jeff Levine

WASHINGTON (CNN) -- The battle to get RU 486, the so-called "day-after pill," approved for use in the United States may be nearing an end.

Conway

"Everything is in place for FDA approval. We just aren't sure exactly at what point the approval process will be finalized," said Margaret Conway of Planned Parenthood.

Sources tell CNN the U.S. Food and Drug Administration may be close to approving the French abortion pill with some conditions. Specifics of a conditional approval are unclear, but sources indicate a remaining hurdle could be the inspection of the manufacturing plant, which is somewhere in Europe.

Government sources say an announcement could come this week. About six months ago, the Population Council submitted its application to market the drug. The FDA is obliged to respond to the application within six months.

Protest

Doctor Wayne Bardin, a former consultant to the Population Council, says he's visited the plant and says it's a good facility that manufactures many similar kinds of drugs. RU- 486 has been approved in France, Great Britain and Sweden and has been used by about 200,000 women to terminate pregnancy.

An FDA advisory panel recommended in July that the agency approve the drug. The FDA could take the panel's advice -- which it usually does -- or turn down the drug, or say it must meet certain conditions before approval.

The availability of RU 486 would give women who want an abortion an alternative to surgery, its backers say. "It does two good things for a woman who hopes to end an unintended pregnancy. That is, she can do it earlier, and without surgery," said Planned Parenthood's Conway.

It would also mean a woman could avoid the emotionally charged atmosphere of an abortion clinic. In theory, thousands of physicians could prescribe the drug.

There is some opposition to the drug's approval, particularly among anti-abortion activists.

Gans

"The Clinton Administration and the FDA want to see this drug introduced before the elections and even if that costs women's lives, and their unborn children their lives, this drug unfortunately could make it into our communities," said National Right to Life Committee member Olivia Gans.

The manufacturer is currently being kept secret to avoid reprisals. Anti-abortion forces hope to discover the maker and launch a boycott.

And Republican Representative Steve Largent of Oklahoma says that if RU-486 is approved he will co-sponsor legislation to keep it off the market. "Abortion, regardless of how you perform it, is killing children," said Largent. He said he would do everything within his means to stop women from using RU 486. "If we can do it legislatively, I would be all for that."

Even though such a bill might pass the majority-Republican Congress, it would almost certainly face a presidential veto.

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