GOP lawmakers urge FDA to halt sales of RU-486

Hearing notes deaths linked to abortion pill


WASHINGTON -- Republican legislators urged federal regulators to halt sales of RU-486 yesterday during a congressional hearing designed to draw attention to five deaths linked to use of the abortion pill and a companion drug.

"There is a serious problem with RU-486, and failing to address this problem by disguising it, ignoring it, minimizing it or causing confusion is a shameful failure," said Rep. Mark E. Souder, an Indiana Republican.

Souder, chairman of the drug policy subcommittee that held the hearing, and Rep. Jean Schmidt, a Republican from Ohio, criticized the Food and Drug Administration for refusing to withdraw RU-486 despite the deaths and other side effects. Souder, who opposes abortion, said the drug should never have been approved.

The hearing intensified pressure on the FDA, which has been investigating whether RU-486 contributed to the fatal infections. Noting those deaths and the possibility that others might have gone unreported, abortion opponents in Congress have been lobbying officials at the White House and the FDA to stop sales of the pill. Legislation pending in the House and Senate would require a halt.

Democrats and abortion supporters assailed the hearing as a blatant effort to inject politics into a serious public health debate. Rep. Elijah E. Cummings of Maryland, the ranking Democrat on the panel, said the subcommittee should not have limited its focus to the deaths that followed use of RU-486. The FDA has received reports of 30 fatal Clostridium sordellii infections, including eight involving women who had just given birth.

"Our focus should be seeking the truth behind the Clostridium sordellii infections rather than attempting to bully the FDA by taking action unsupported by science," Cummings said.

About 575,000 American women have used RU-486. Taken up to 49 days after a pregnancy, the pill, which kills a fetus, is followed by use of a companion drug, misoprostol, that expels the dead fetus. Studies have shown that the procedure is safer than childbirth.

Through March 31, the FDA has received reports of 950 serious side effects after use of RU-486, including nine life-threatening incidents, 232 hospitalizations, 116 cases of heavy bleeding that required transfusions and 88 infections. Four of the five women who died of septic shock were from California, the other from Canada.

Another American died of septic shock after taking the abortion pill, but she had an infection different from the Clostridium sordellii infection linked to the other deaths, said Dr. Janet C. Woodcock, an FDA deputy commissioner.

Woodcock testified that the FDA approved RU-486 in 2000 after a thorough review and disputed Souder's assertion that the agency had circumvented normal procedures. The only departure from the norm, she said, was that more restrictions were imposed on its use than most drugs face.

Aside from the infections, Woodcock said, the side effects were within the expected range based on clinical trials. She defended the FDA's response.

The FDA has added warnings to the drug's labels and directions. Officials from the FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health met in Atlanta last week to review preliminary findings and plot further research.

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