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FDA proposals may restrict use of drug, abortion advocates fear

WASHINGTON (BP)–The abortion drug commonly known as RU 486 continues to move toward introduction into the United States, but its advocates fear recently revealed rules tied to its approval by the Food and Drug Administration may severely restrict its use, according to a published report.

The FDA has proposed the abortion drug be approved with the following guidelines, according to a June 7 report in The Washington Post:

— There would be a national registry of all physicians who prescribe RU 486.

— Only doctors trained in performing surgical abortions could prescribe the drug.

— Those doctors must have admitting privileges at a hospital within one mile of their offices.

— A study would be conducted of all women who have had abortions using RU 486.

If the FDA’s proposed guidelines are approved, they apparently would dramatically restrict the number of doctors who would prescribe the drug. For one thing, the process would not be nearly as secretive as abortion rights advocates had expected.

“What the FDA is talking about would so violate physicians’ privacy and security concerns that [RU 486] could be approved by the agency but never really be on the market,” said Planned Paretnhood Federation of America President Gloria Feldt, according to The Post.

Population Council spokeswoman Sandra Waldman told the newspaper the FDA proposals “are more restricted than we expected.” The Population Council is a New York-based, nonprofit group that holds the patent to the drug.

The FDA declined comment on its proposed restrictions, according to The Post.

News of the FDA’s proposed guidelines came after a representative of The Danco Group, a New York pharmaceutical company arranging for manufacture of the drug, revealed them at a June 2 meeting of abortion rights advocates, according to The Post. The Danco representative said the proposals had arrived in a letter from the FDA the previous day, The Post reported.

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.

The Southern Baptist Ethics & Religious Liberty Commission and other 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.

The FDA process on the drug has taken much longer than abortion rights advocates had hoped. In the most recent development before this report, the FDA issued an “approvable” letter in February to the Population Council, delaying approval because “remaining questions need to be resolved before final marketing approval can be granted,” according to an agency news release.

Despite pro-life efforts that succeeded during the Bush administration, 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. 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 is available in such countries as France, Great Britain, Spain, Sweden, Russia, China and Israel, according to The Post.

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