FDA is urged to halt sale of RU-486

Conservatives point to 4 deaths possibly linked to abortion pill


WASHINGTON -- Conservatives are attempting to build on recent successes in the regulation of contraceptives and reproductive products by pushing the Food and Drug Administration on a new target: RU-486, the abortion pill.

Bolstered by news that four California women died after using the drug, they are calling for an end to sales. Republican Sen. Jim DeMint of South Carolina, a leading opponent of RU-486, says the FDA has told him it would restrict sales if additional deaths it is examining turn out to be linked to the pill.

"Increasingly, they are aware that it is a dangerous drug," DeMint said in an interview.

Of the chances that the FDA will halt sales, he said, "I'm very hopeful."

DeMint said he met with then-FDA Commissioner Dr. Lester M. Crawford over the summer and has been in contact with agency officials since, urging that sales of the drug be suspended.

Julie Zawisza, an FDA spokeswoman, said of the deaths, "We don't know whether or not there's any link [to RU-486]."

Agency officials declined to say whether the FDA is considering restricting access and did not answer questions about whether the agency has met with any lawmakers.

"Regulatory decisions at FDA are made by career experts based on sound scientific information and regulatory and legal considerations," an agency spokesman said in a statement.

But abortion-rights advocates are growing alarmed in light of the FDA's recent moves.

In August, the agency put off approving the sale of a morning-after pill, known as Plan B, to women 17 years and older without a prescription. The agency overruled staff and ignored the consensus of outside experts, saying further study was needed.

This month, the FDA proposed warning that condoms aren't entirely effective at reducing the risks of pregnancy or sexually transmitted diseases, a move advocated by some conservatives and Republicans in Congress.

"What is unfortunately clear is we can't count on them being independent," said Susan F. Wood, who headed the FDA's office of women's health before resigning to protest the delay on the Plan B pill, which she argues was politically motivated.

Wood said she fears that top agency officials will similarly take action on RU-486 in defiance of staff and without a scientific justification. "I'm worried," she said.

Cynthia Summers, a spokeswoman for RU-486's manufacturer, Danco Laboratories, said the company enjoys a good relationship with the FDA and has no reason to think the agency would act to restrict sales.

Sold under the brand name Mifeprex, RU-486 has long been central to the abortion wars. Shortly after he recently resigned as FDA commissioner, Crawford told Forbes.com that dealing with the controversy was one of the reasons for his departure.

More than 500,000 women have used RU-486 since the FDA approved it five years ago. The drug doesn't prevent pregnancy like the morning-after pill but ends one. Women take the drug up to 49 days after conception, followed a few days later by use of another medicine to induce contractions.

The regimen is called a medical abortion, and it's precisely because RU-486 doesn't require invasive surgery that opponents see it as especially insidious.

"This is one way of helping make abortion doable in the mainstream medical community because all doctors have to do is hand over a pill," said Wendy Wright, executive vice president of Concerned Women for America. "That's a lot easier than reaching inside a woman and dismembering a baby."

The four deaths in California have galvanized Wright and other opponents. The deaths date back as far as 2003, but they weren't associated with RU-486 use until more recently.

In July, the FDA began warning about the drug's possible link to the deaths. This month, the agency updated its warning after concluding that all four women tested positive for the bacteria Clostridium sardellii.

The FDA said in this month's update that it had tested batches of the drug and did not find any contamination. And it emphasized that it had not established that the drug's use caused the deaths. The agency, and the Centers for Disease Control and Prevention, are investigating and planning a scientific meeting, an FDA spokesman said.

Conservative opponents have seized on the findings to argue for immediate withdrawal of the drug from the market.

A Canadian woman also died, in 2001, after receiving Mifeprex during a clinical trial. Opponents assert that hundreds more women have died or been injured than have been reported to the FDA, and they have called on the agency to act now to protect more women from harm.

"How many more women have to die before FDA extinguishes this murderous fire and pulls RU-486 from the market?" Christopher M. Gacek, a senior fellow at the Family Research Council, wrote in its Nov. 11 newsletter.

Many liberal Mifeprex supporters had been confident enough that the FDA wouldn't take action that they didn't file a response after opponents asked the agency, in 2002, to suspend and review approval of the drug.

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