U.S. unlikely to get abortion pill soon German firm wary of possible boycott

November 15, 1992|By New York Times News Service

WASHINGTON -- There is still little prospect that Frenc abortion pill RU-486 will be available in the United States soon, despite President-elect Bill Clinton's willingness to encourage the marketing of the drug in the United States.

Officials of the Food and Drug Administration and the French company that makes the drug, Roussel Uclaf, agree that whether the abortion pill is sold in the United States depends mostly on top officials of the German company Hoechst AG, which controls Roussel, and how those corporate officials view abortion politics in Germany and the United States.

Dr. Andre Ulmann, head of endocrinology in the Research, Development and Marketing Department at Roussel, said the change of administration "will certainly have an effect on whether RU-486 may be available in the United States, but it is still too early to say what effect."

Top Hoechst officers are reluctant to offer the drug in other countries for fear of protests by anti-abortion groups. The drug is now available only in France, Britain and Sweden.

"There are still vocal minorities," Dr. Ulmann said. "Any company is always frightened when they are threatened with boycott.

"I think the threat in this case is not real, but you can't argue with the top management of a big company."

Dr. Ulmann also said that Hoechst needs to find an American company willing to buy a license to market the drug. He said that Roussel officials had offered several large American corporations the chance to license the drug in the United States but that all had turned them down. He said that if Roussel did decide to seek approval for the drug in the United States it would be likely to license the rights to a small company that can dedicate itself largely to the one product. He said only a few such companies exist.

He said he could not name any of the companies, large or small, that have had talks about RU-486.

A key to the drug's prospects in the United States, Dr. Ulmann said, will be the public reaction in Germany to a vote in the German Senate on whether to make abortion widely available in that country. The debate on abortion in Germany is similar to that in the United States.

A U.S. president has little direct influence over whether a drug is marketed. Drug policy is made by the Food and Drug Administration under a voluminous set of laws and procedures to ensure that medications are effective and relatively safe.

The president could recommend to the company that it apply for approval, as health officials did in Britain in order to get RU-486 approved there last year. The process for approving drugs in Britain is similar to that in the United States.

The only other issue on which the president would normally have influence is whether the drug may be imported for personal use by women. The Bush administration made it illegal to import it, a position bolstered earlier this year when it won a Supreme Court battle against a woman, Leona Benton, who had tried to bring the drug into the country.

Even if the import policy for individuals were reversed, it would make little difference to most women. The drug is under strict control in the countries where it is legal, and only women who need it themselves may obtain it. Even then, it can be taken only in clinics in the presence of medical personnel.

Dr. David Kessler, the FDA commissioner, has said he would welcome an application for approval of RU-486, and other FDA officials have said that approval could be relatively quick because a large volume of scientific data is available: more than 100,000 women have used it.

RU-486 is an anti-progestin, which blocks the action of the natural hormone progesterone. Progesterone prepares the uterus for pregnancy, tranquilizing it to prevent contractions and preventing bleeding so that the uterus may build up a place for the embryo to grow. Thus, when RU-486 is taken, it cuts off the blood to the embryo and induces bleeding and contractions, which flush it out.

A hormone, prostaglandin, is taken with RU-486 to increase the strength of the contractions to help complete the abortion in a few days.

The chief side effect of the drug has been heavy menstrual bleeding, which in a few cases has led to transfusions. Nausea and vomiting have also been reported.

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