FDA chief's meeting with French executive could pave way for abortion pill in U.S.


WASHINGTON -- The president of the French company that makes the abortion pill RU-486 told FDA Commissioner David A. Kessler yesterday that he believes the drug should be made available in the United States, the commissioner said.

Dr. Kessler and the pharmaceutical executive, Edouard Sakiz of Roussel-Uclaf, held a meeting in Rockville, Md., that could signal the first step toward bringing the abortion drug to market in the United States.

Dr. Kessler said Mr. Sakiz was willing to discuss how the drug could be brought to market by another company or research zTC institution under an agreement with his company.

Marketing of the abortion pill has been long sought by women's groups and long opposed by anti-abortion groups.

The company had previously refused to seek approval to market RU-486 in the United States because of what it described as the anti-abortion climate in the nation, notably the opposition to abortion expressed by Presidents Ronald Reagan and George Bush.

Also, anti-abortion groups said they would boycott the U.S. subsidiary of Roussel-Uclaf's parent, Hoechst AG, if the drug was marketed in the United States.

One anti-abortion group indicated yesterday that the boycott would proceed if a marketing application was filed in the United States. The Hoechst U.S. subsidiary, Hoechst Celanese, makes a variety of chemicals and drugs.

President Clinton said during the presidential campaign that women in the United States should have the option of using RU-486. He repeated that assertion last month when he signed five memorandums revoking a decade of abortion-related bans imposed by the Republican administrations.

The Food and Drug Administration has said in the past that it would take rapid action on an application to market RU-486. If such an application went smoothly, it could be 18 months between the filing and the time the drug went on the market.

The drug is available only in government clinics and under strict guidelines in France, Britain and Sweden. About 120,000 women have taken the drug in what amounts to one of the largest drug safety tests in industry history, and it has proved effective in 96 percent of cases.

"I told Mr. Sakiz that if there is a safe and effective alternative to a surgical procedure for abortion, American women should have access to that alternative," Dr. Kessler said.

"I reiterated the FDA position that a new drug application should be submitted. Mr. Sakiz agreed that RU-486 should be made available in the United States, but he emphasized the importance of achieving that without the involvement of Roussel-Uclaf" directly in the United States market.

Efforts to reach Mr. Sakiz were unsuccessful.

The news was greeted with excitement and wariness by advocates of the drug.

"This is very promising news," said Simon Heller, a senior lawyer for the Center for Reproductive Law and Policy, a nonprofit group based in New York, but he added that the company should not wait to apply to market the drug and should add no restrictions on bringing it to the United States beyond those any other drug with a similar safety record would have.

Lawrence Lader, president of the Abortion Rights Mobilization, said, "This is an important first step, but we still must have total commitment from Roussel to find a U.S. drug manufacturer which will make or distribute RU-486 here. Meanwhile, we are continuing our campaign to push such alternatives as the Chinese pill or a pill to be made in the U.S."

Mr. Lader's group announced last week that it had obtained agreement from the Chinese government to bring a Chinese version of the pill to the United States for testing, if not for marketing. That pill also would have to pass FDA tests.

Richard Glasow, a specialist on the topic for the National Right to Life Committee, one of the leading opponents of RU-486, said last night in a telephone interview, "This is not a done deal. Hoechst and Roussel have violated their own criteria that were to be met before letting the drug into the country. The abortion issue is in no way settled in this country."

Dr. Kessler said Mr. Sakiz told him that as a first step toward bringing in the drug, it would be important to have a large-scale U.S. clinical experiment. That would ensure its safety and effectiveness and would be a first step toward training U.S. doctors to use the drug.

If the drug were marketed in the United States, the rules for dispensing it would be different from those in the other countries because most obstetric and gynecologic care in the United States is in private doctor's offices rather than clinics.

But the company would like to assure that it is carefully administered under a doctor's supervision, rather than handed out for use at home.

Dr. Kessler said he and Mr. Sakiz agreed that apart from establishing such a large controlled trial, the central issue was who could be found to distribute the drug in the United States.

Roussel has indicated that it does not want to get directly involved indistributing the drug in the United States because of fears of a boycott by abortion opponents and because the U.S. market is not as tightly controlled as those that rely on government clinics.

They agreed, Dr. Kessler said, that there are three possibilities: an established pharmaceutical company, a major research center or a large university.

Mr. Heller said that the news of the company's willingness to bring the drug to the United States was welcome but still sounded tentative in some ways.

"Only one company in the U.S. is willing to do contraceptive work, let alone finding one willing to work on abortion," he said. "It might be hard to find a suitable intermediary. Also, new, large-scale trials would duplicate the trials already done in France and elsewhere. They are not really needed. And a third thing that is disturbing: Why do doctors need to be trained to give pills? Physicians are already trained to do that."

Advocates of abortion rights argue that the drug could change the terms of the political debate over abortion in the United States because RU-486 need not be taken in clinics, which are vulnerable to boycotts, but instead can be privately administered in doctor's offices.

That would remove the issue from public settings and lessen the government's role in abortion.

But groups opposed to abortion have vowed to take the fight wherever needed to stop the use of the pill, chiefly a boycott.

The price of the drug has been set by the company at a level roughly equal to surgical abortion, which in the United States would be about $300.

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