Abortion pill OK sought in U.S. Talk of alternative leads to statement on French drug


The New York nonprofit group holding the patent rights to the French abortion pill in this country announced yesterday that it had filed an application asking the federal Food and Drug Administration to approve the drug, known as RU-486 in France and mifepristone in this country.

The group, the Population Council, also said that it had given the exclusive right to arrange the manufacture and distribution of the pill to a newly formed private company, Advances in Health Technology.

"We hope that mifepristone will be available to women in this country by the end of the year," said Dr. Susan Allen, the president of the new company. Once approved, she said, the drug will be available for uses other than abortion; mifepristone has been used experimentally in the treatment of breast cancer and as a morning-after contraceptive.

Dr. Allen said her company, which will focus on physician education, had completed the arrangements for manufacturing and distributing mifepristone, but she declined to identify the companies involved.

The announcement about the French abortion pill came in response to publicity last week about the use of another drug, methotrexate, to terminate pregnancy.

Although the FDA has never approved methotrexate for abortions, it is used in treating cancer, arthritis and other diseases. While a few doctors have started to prescribe it "off-label" for abortions, doctors have yet to agree on precise guidelines for its use.

Some abortion providers have expressed enthusiasm for methotrexate. But others were more cautious, saying they would probably wait for agreement on a protocol for its use.

Methotrexate was discussed at the annual meeting last weekend of the National Abortion Federation, a group that represents those who perform half the nation's abortions.

While doctors generally agree that methotrexate is safe and effective, some say it will be only a useful bridge until Americans have access to the French abortion pill, which has a longer record of clinical tests.

"When I developed the methotrexate abortion, it was because mifepristone was not available," said Dr. Mitchell Creinin of the University of Pittsburgh, who conducted the first methotrexate trials in 1993.

The French abortion pill has been used by hundreds of thousands of women in other countries, and its safety and efficacy has been shown. But its path to this country has been difficult.

In May 1994, under pressure from the Clinton administration to give American women access to RU-486 but fearful of anti-abortion protests, the French company that developed the drug -- Roussel Uclaf, which has a German parent, Hoechst -- donated the exclusive right to market the drug in this country to the Population Council.

The Population Council conducted clinical trials last year, but it did not release the test results. Until this weekend, it kept confidential that it had submitted a new drug application to the FDA last month. The agency is taking six months to a year to act on applications.

Sandra Waldman, a council spokeswoman, said the group had hoped to work quietly but had felt compelled to make an announcement because "publicity about methotrexate made it sound as though everyone had written off mifepristone."

There are many similarities between methotrexate and mifepristone abortions. In both cases, women must go through a two-step process, getting one dose of the drug to interrupt the pregnancy, then returning days later for another drug, a prostaglandin, to cause the uterine contractions that expel the fetus.

Both drugs hold the potential for reshaping the bitter politics of abortion in this country by making abortions available far more privately, in any doctor's office, or perhaps even at home.

But there are differences between the drugs. For one thing, mifepristone abortions are quicker, with the woman coming in for the prostaglandin just two days after getting the mifepristone pills.

With methotrexate, the woman waits a week before returning for the prostaglandin.

Methotrexate costs about $10 per abortion. Mifepristone is expected to cost about $75. There is some debate about how far into pregnancy either drug should be used. Mifepristone has been tested on pregnancies up to nine weeks after conception, but it might work better in pregnancies of seven weeks or less. Some doctors limit methotrexate to pregnancies of no more than six weeks, while others set the limit at eight weeks.

Pub Date: 4/01/96

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