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Friday September 29, 2000

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FDA Approves Abortion Pill

By The Associated Press

WASHINGTON - Capping a bitter 12-year battle, the government yesterday approved use of the abortion pill RU-486, a major victory for abortion-rights advocates that could dramatically alter abortion in this country.

The long-expected decision by the Food and Drug Administration allows Americans an early-abortion method already used in France, Britain, China and 10 other countries. The action is expected to make abortion in the United States more accessible and more private.

Coming in the final weeks of the presidential campaign, the move also is sure to renew fierce political debate. Republican candidate George W. Bush, whose father's administration banned RU-486 imports in 1989, opposes abortion. Vice President Gore supports the pill option.

The pill, known chemically as mifepristone and by the brand name Mifeprex, will be available to doctors within a month.

Mifepristone, which blocks a hormone vital to sustaining pregnancy, only works during the first seven weeks of pregnancy, when an embryo is about one-fifth of an inch; that is earlier than surgical abortions often are offered.

Two days after taking mifepristone, women take a second drug that causes cramping and bleeding as the embryo is expelled, much like a miscarriage.

"For those who choose to have an early termination of their pregnancy, this is a reasonable medical alternative," said FDA Commissioner Jane Henney, who approved mifepristone based on studies that found it 92 percent to 95 percent effective in causing abortion.

Complications are rare; serious bleeding occurs in 1 percent of women. But the pill-caused abortion requires three doctor visits and, to ensure it is performed accurately, the FDA restricted its use to doctors with certain training and mandated that detailed patient-information brochures be given to every woman.

Proponents hailed FDA's move. Although some doctors already use a cancer drug called methotrexate to cause abortion - legal although not formally FDA-approved - they said mifepristone will increase access to the nonsurgical method.

"At long last, science trumps anti-abortion politics and medical McCarthyism," said Eleanor Smeal of the Feminist Majority Foundation.

Mifepristone may "turn the tide against anti-choice intimidation," because doctors who don't offer surgical abortion can use the pill in private offices instead of protester-targeted clinics, added Planned Parenthood president Gloria Feldt.

But anti-abortion groups, which fought mifepristone by threatening U.S. drug companies with boycotts, pledged to continue fighting.

"We will not tolerate the FDA's decision to approve the destruction of innocent human persons through chemical abortion," said Judie Brown of the American Life League.

"Never before has the FDA approved a drug intended to kill people," said Rep. Tom Coburn, R-Okla., who promised legislation calling for severe limits on which doctors could administer mifepristone.

On the campaign trail, Bush called the FDA's decision "wrong," saying "I fear that making this abortion pill widespread will make abortions more and more common." His campaign said if elected, Bush wouldn't have the authority to overturn the FDA's decision, but he would order a probe of whether the agency's review was influenced by politics.

Gore praised the pill's availability. "Today's decision is not about politics, but the health and safety of American women and a woman's fundamental right to choose," he said.

Health experts note abortions did not increase when RU-486 debuted in France in 1988, or later across Europe.

The pill's journey to the United States began in 1994, when French manufacturer Roussel-Uclaf turned over U.S. rights to the drug to the nonprofit Population Council of New York. The council began clinical trials needed for FDA approval and created Danco Laboratories, a small company that will market mifepristone.

The FDA in 1996 declared mifepristone a safe and effective early abortion method, but delayed full approval because Danco had problems satisfying manufacturing and other final requirements.

President Clinton said the FDA's four-year investigation shows the decision was "purely one of science and medicine." He said the FDA "bent over backward to do a lot of serious inquiries. ... They took so long to try to make sure they were making a good decision."

But the National Right to Life Committee condemned the FDA's unprecedented decision to let Danco keep secret the identity of the manufacturer, reportedly located in China, that actually makes the pills.

"The public has a right to know whether the abortion pill will be imported from the People's Republic of China, a nation that is a leading source of tainted drugs," NRLC said.

FDA's Henney cited anti-abortion violence in her decision to keep the manufacturer secret, and to keep secret the names of FDA employees who scrutinized the drug. The FDA also increased security in some of its offices.

"The climate around the reproductive rights issue and personal safety issues are in our minds," she said.

But FDA inspectors did travel to the mifepristone factory, and it passed all federal safety and quality rules, she said.