RU-486 CLEARED FOR USE IN U.S. : `ABORTION PILL' DEEMED SAFE.

Byline: Gina Kolata The New York Times

An abortion-inducing drug has cleared the last major obstacle to marketing in the United States by receiving conditional approval from the Food and Drug Administration, the drug's sponsor announced Wednesday.

The sponsor, the Population Council, a family-planning research group based in New York City, said it hoped to have the pill, long available abroad, on the U.S. market by the middle of next year.

The Population Council said the FDA had sent it a letter of conditional approval advising that the drug, RU-486, or mifepristone, had met the agency's requirements of being safe and effective.

The FDA asked for additional information, however, involving the drug's labeling and the manufacturing process.

While both the Population Council and the FDA declined to specify the precise nature of the further information required by the agency, the sponsor's plans to market the drug by mid-1997 suggest that it does not see any major remaining hurdles in its path.

The agency's latest step toward allowing the sale of mifepristone was not unexpected: a committee of advisers to the FDA recommended approval two months ago.

But the announcement by the Population Council came on the eve of a hotly contested abortion vote in the House of Representatives, and so added to a newly developing furor over the issue.

The House vote, scheduled for Wednesday, concerns a kind of late-term procedure that abortion opponents call a ``partial birth abortion.'' Congress voted earlier this year to outlaw the procedure, but the legislation was vetoed by President Clinton. At stake in Wednesday's vote is whether to override that veto.

Anti-abortion forces, increasingly doubtful of their ability to overturn Roe vs. Wade, the Supreme Court decision of 1973 that legalized abortion, have focused instead on efforts to outlaw individual methods, like the late-term procedure.

Mifepristone is another target, particularly because it can be prescribed and administered in the privacy of a doctor's office, away from demonstrations at abortion clinics.

Although neither of the major parties' presidential candidates has much interest in pushing the abortion issue into the midst of the 1996 campaign, the Republicans adopted tough anti-abortion platform language at their convention in August.

And their nominee, Bob Dole, has said - most recently in a pledge to the Christian Coalition last weekend - that as president he would sign a bill banning the late-term procedure.

As for mifepristone, a Dole spokesman said Wednesday that the nominee had ``long been troubled'' by it and had spoken out earlier in his campaign against its marketing.

In contrast, it was President Clinton who, shortly after taking office, ordered the FDA to search for ways to get the drug onto the U.S. market, where foreign manufacturers, fearful of involvement in the nation's abortion wars, had long been reluctant to bring it.

A White House spokeswoman, Kathy McKiernan, declined to comment Wednesday on the latest development concerning mifepristone. She referred all queries to the FDA, since the matter was ``part of the regulatory process.''

Anti-abortion groups were not nearly so reticent.

``It's a tragic step,'' said Michele Arocha Allen, a spokeswoman for the National Right to Life Committee. ``It means that tiny children's hearts will stop beating. And their mothers may be threatened, since we don't know the long-term side effects of this drug.''

Allen said her organization ``will definitely continue to educate Americans about what is going on.''

Abortion rights advocates called the FDA's letter a major advance.

``We haven't had anything like this since the birth control pill,'' said Kate Michelman, president of the National Abortion and Reproductive Rights Action League.

Michelman said mifepristone would allow women who want to terminate a pregnancy within the first seven weeks of their last menstrual period the option of taking pills in a doctor's office instead of having a surgical abortion at a clinic.

By avoiding abortion clinics, she said, women will have ``privacy and safety and freedom from blockades and harassment.''

Mifepristone induces abortions by blocking progesterone, a hormone necessary to sustain a pregnancy. In the regimen, a woman first swallows three pills, each containing 200 milligrams of mifepristone, and then, 36 to 48 hours later, returns to her doctor's office to take two tablets of misoprostol, a drug that makes her uterus contract.

Most patients abort the fetus within the next 24 hours, although the method fails in 5 percent of women, who then require surgical abortions.

The most serious side effect of mifepristone is severe bleeding. which occurs in 1.4 percent of women. Other, more common side effects are painful uterine contractions, nausea, vomiting and diarrhea.

The drug has been used by more than 250,000 women around the world and is sold in France, Britain, Sweden and China. And it has taken on almost mythic dimensions in the battle between advocates and opponents of abortion rights in the United States.

Dr. Warren Hern, director of the Boulder Abortion Clinic in Colorado, said it had become politically incorrect to even question whether the drug would swing the pendulum in the abortion debates.

``A lot of people in the pro-choice movement see this drug as a panacea,'' Hern said. ``They have a tremendous amount of ideological fervor.''

And some of the drug's champions readily describe just such zeal.

``We've been working on this since 1989,'' said Eleanor Smeal, president of the Feminist Majority Foundation. Smeal said her group had delivered 700,000 petitions to Roussel Uclaf, the French company that produces the drug in Europe, and its German parent, Hoechst AG, to persuade them to donate the U.S. patent rights to the Population Council so that the drug could be marketed in the United States.

Hoechst donated those rights in May 1994, and the Population Council began testing mifepristone in the United States. On March 18, the group submitted to the FDA a 164-volume application for permission to market the drug.

The agency considered mifepristone a priority drug, because there is nothing like it being sold in this country. That means the agency had six months to act on the application.

On July 19, an FDA advisory board recommended approval. And Wednesday, exactly six months from the date of the application, the Population Council announced that it had received the letter of conditional approval.

Sandra Waldman, a spokeswoman for the Population Council, said the organization was so concerned about the possibility of boycotts or violence directed at mifepristone's manufacturer that the name of that drug company was being kept secret. She said the name of the distributor would be disclosed when the FDA gave final approval.

Waldman declined to give details on what additional information the FDA required or when the Population Council would make it available, but said that the group regarded the letter of conditional approval as ``a major step.''

``We can't really say with exactitude,'' she said, ``but we hope that by the middle of 1997 we'll be able to have this on the market.'' She said women would probably pay about $350 for the drug regimen, about the same as the price of a surgical abortion.