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FDA Again Delays Abortion Pill Approval
Questions on the Manufacturing and Labeling of RU-486 Remain Unresolved

By Marc Kaufman
Washington Post Staff Writer
Saturday, February 19, 2000; Page A02

The federal government again delayed the long-sought approval of the abortion drug RU-486 yesterday, disappointing advocates eagerly awaiting the arrival of a pill they believe will transform the abortion debate in the United States.

In a terse statement, the Food and Drug Administration said that unspecified questions "need to be resolved before final marketing approval can be granted."

The agency ruled almost four years ago that RU-486, or mifepristone, was "approvable" in terms of its medical safety and effectiveness, and for some time abortion rights groups have been predicting that final approval is imminent.

But the process of finding and approving a manufacturer has been difficult, and made highly contentious by the strong opposition of antiabortion groups. The French company that developed the drug in the 1980s refused to distribute it in the United States because of boycott fears, and no American pharmaceutical company would manufacture it.

"It's disappointing, but these things happen," said Sandra Waldman, spokeswoman for the Population Council, the New York reproductive rights group that was ultimately granted the American rights to mifepristone. "It would have been nicer to be approved than approvable, but we are continuing in our discussions with the FDA," she said. "It will just take a little longer."

The outstanding issues, she said, involve the manufacturing and labeling of the drug. Neither she nor the FDA would elaborate on what those issues are, but in the past they have been technical, such as conditions at the manufacturing plant and how much of the drug is needed to end a pregnancy.

The Population Council has granted the licensing rights to manufacture and distribute RU-486 to a New York start-up company named Danco Laboratories LLC. Danco said yesterday that it is cooperating with the FDA and is confident the drug ultimately will be approved.

Another potential FDA problem involves the name and location of the subcontracting company that would actually manufacture the drug--information that has not been made public. The FDA historically has required information about the manufacturer to be published, but in this case the issue has become unusually complex and political by the history of antiabortion protest and violence. A Hungarian company that agreed to produce the drug in 1995 later backed out of its agreement, which had included a provision that it not be named in public.

Mifepristone is designed for women up to 49 days pregnant, and it has been widely used in Europe for more than a decade. It causes an abortion by making it difficult for a fertilized egg to attach to the uterus; a second drug, misoprostol, triggers contractions.

Abortion rights groups believe medical abortion can revolutionize the abortion debate because doctors can administer it in their offices without the kind of notice and controversy associated with surgical abortion clinics. Antiabortion groups have been equally opposed to the FDA's approval of the drug, and their supporters in the House have twice passed resolutions blocking the agency from reviewing mifepristone. The Senate has not taken up the issue.

"We don't exactly know what's happened at the FDA, but we hope they're reviewing some of the basic documentation about RU-486," said Laura Echevarria, spokeswoman for the National Right to Life Committee. "We believe this is a dangerous drug for mothers and obviously for the babies, and we've asked the FDA to review the whole approval process."

Gloria Feldt, president of Planned Parenthood Federation of America and an advocate for RU-486, said yesterday that she is concerned that politics could be playing a role in the FDA delays.

"But I have no specific knowledge, and do have some confidence in FDA's professional integrity," said Feldt, whose group had predicted in December that RU-486 would be approved in the first quarter of this year. "There's no reason to believe the FDA commitment to moving forward will not ultimately happen."

Although mifepristone has not been approved for general use, it has been made available to thousands of American women at 15 centers from Bellevue, Neb., to Cherry Hill, N.J., through a research program. A study published in 1998 in the Archives of Family Medicine reported that 95 percent of American women who have used the drug would recommend it to others.

While the process of approving RU-486 has clearly been complicated by the opposition of antiabortion groups, the Population Council has also experienced independent problems. A lawyer initially selected to develop and market the drug turned out to have been disbarred, and the dispute with the original Hungarian manufacturer ended in a breach-of-contract lawsuit.

While asking for more information yesterday, the FDA reissued its "approvable letter" for RU-486. The FDA issued its first approvable letter for RU-486 in September 1996, and yesterday's action was in response to Population Council answers to previous agency questions.

© Copyright 2000 The Washington Post Company

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