Wednesday, November 17, 2004

Republican lawmakers plan to reintroduce a bill to suspend the sale of RU-486, the abortion pill, and probe the process surrounding its approval now that three U.S. deaths have been linked to the drug.

The measure would ban the drug temporarily while the Government Accountability Office, Congress’ investigative arm, conducts a six-month independent review of the approval process the agency used to declare RU-486 “safe and effective” in 2000.

One of the bill’s co-sponsors, Sen.-elect and Rep. Jim DeMint, South Carolina Republican, said questions remain about the Food and Drug Administration’s (FDA) approval of RU-486, whose generic name is mifepristone, under a protocol reserved for drugs intended to treat life-threatening diseases.

That decision, he said, which came during the Clinton administration, was “thoroughly political, not scientific.”

If the FDA is found to have violated its own rules, the abortion drug would be banned indefinitely, said Mr. DeMint. If not, the suspension would be lifted.

The bill was introduced in November 2003 after the death of Holly Patterson, 18, of Livermore, Calif. She died of a bacterial infection seven days after she took RU-486 to end an unplanned pregnancy that began when she was a minor.

The drug stops a fetus from growing and expels it in a manner similar to a miscarriage.

Chief sponsors of the bill, officially known as the RU-486 Suspension and Review Act, also include Rep. Roscoe G. Bartlett, Maryland Republican, and Sen. Sam Brownback, Kansas Republican.

“It’s an unequivocal yes that we will reintroduce the bill,” said Lisa Wright, Mr. Bartlett’s press secretary, given that new safety warnings are being put on the drug after the deaths of three American women who took it.

On Tuesday, FDA officials confirmed that Miss Patterson and two other American women died after taking the drug. But they said they do not have evidence that RU-486 was responsible for the deaths.

Dr. Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, said RU-486 will remain on the market with a “strengthened” black-box warning, citing a risk of fatal bacterial infections, septic shock and heavy bleeding, and will be monitored.

Dr. Galson said he does not think the drug was related to the fatal infections that two of the women contracted.

To date, 360,000 American women have used RU-486 and the FDA has received about 600 complaints about “adverse events” associated with the drug, Dr. Galson said.

Monty Patterson, Miss Patterson’s father, said a Canadian woman died Sept. 1, 2001, after taking RU-486 in a clinical trial. He said scientists determined that the same type of bacteria that killed her also was responsible for his daughter’s death. RU-486 has not been approved in Canada, he said.

What’s more, Mr. Patterson said, “There was another girl who died early this year in Sweden” after taking the abortion pill. “She bled to death,” he said.

The measure to suspend and review approval of RU-486, commonly called Holly’s Law, has 84 sponsors in the House and eight in the Senate.

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