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RU 486 still not approved as FDA issues new letter

WASHINGTON (BP)–The French abortion pill, commonly known as RU 486, still has not received final approval from the Food and Drug Administration, but the government agency recently signaled it continues working toward that goal.

The FDA issued what is called “an approvable letter” to the Population Council for the abortion drug, meaning “remaining questions need to be resolved before final marketing approval can be granted,” according to an agency news release.

The FDA action comes at a time when advocates for the abortion drug hoped it would already be on the market. Last March, The Danco Group, a New York pharmaceutical company arranging for manufacture of the drug, said it expected to have FDA approval before the end of 1999, according to a report in The Washington Post.

Pro-lifers greeted the announcement of an approvable letter instead of final approval with relief, if not satisfaction.

“What that means is very fuzzy. It’s obviously better than approval,” said Randall O’Bannon, director of education and research at the National Right to Life Educational Trust Fund.

Ben Mitchell, a biomedical consultant for the Southern Baptist Ethics & Religious Liberty Commission, said he was “heartened that the FDA is taking more time, but we would ask it to look carefully at its effects, not just on pregnant women but its effects on unborn children as well.”

“Our conclusion has to be that any drug that targets unborn children for death should not be approved or introduced in this country.”

Mitchell is assistant professor of bioethics and contemporary culture at Trinity Evangelical Divinity School in the Chicago area.

A phone call to a FDA spokesperson for clarification of the Feb. 18 announcement was not returned in time for this article.

RU 486, also known as mifepristone, is used with a prostaglandin, misoprostol, to induce abortion normally in the first seven weeks of pregnancy. Mifepristone causes the lining of the uterus to release the baby, who usually suffocates or starves to death. Misoprostol, taken two days after mifepristone, causes the uterus to contract, expelling the child’s body.

Pro-life organizations have long fought against RU 486’s introduction into the United States, and the U.S. House of Representatives twice has voted to prevent federal funds from being used in the testing, development or approval of any abortion-inducing drug. Both times the Senate has refused to follow the House’s lead.

Despite pro-life efforts that succeeded for a few years, the abortion drug has been moving toward widespread availability since President Clinton took office more than seven years ago. Two days after he took office in 1993, Clinton issued a directive clearing the way for importation of the abortion pill into this country. In 1994, Roussel Uclaf, the French manufacturer of RU 486, donated the U.S. patent to the Population Council, a New York-based, nonprofit group. The FDA issued the original approvable letter for RU 486 in September 1996.

More than 5,000 women in this country have used the drug in clinical tests. Tests on 2,100 women in 1994 and ’95 showed the two-step method ended in abortion for 92 percent of women in the first seven weeks of pregnancy. If abortion does not occur through the two-drug process, a surgical abortion is performed.

Pro-lifers have warned RU 486 not only kills a child but poses a threat to the physical and psychological health of women. The tests in ’94 and ’95 showed 51 percent of women aborted after they left the clinic. Side effects in the trials included severe bleeding, severe cramping, vomiting and nausea.

In late 1990, ERLC President Richard Land joined 10 other pro-life leaders in traveling to Europe to inform Roussel Uclaf and its German parent company of American opposition to the introduction of RU 486 into this country.

RU 486 has received approval in 13 countries, according to U.S. News and World Report. It is commonly used in France, Great Britain, Sweden and China, The Post reported.