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By Robert Longley, About.com Guide to US Government Info since 1997

GOP Lawmakers to Try RU-486 Ban Again

Saturday November 20, 2004
Republican leaders in Congress plan to mount yet another legislative assault against RU-486 -- the abortion pill. FDA approval of RU-486 (mifepristone and misoprostol - brand name Mifeprex) took 12 years filled with political warfare waged between women's rights groups in support of the drug and abortion opponents who declared it immoral and dangerous. A similar bill introduced in 2001, was defeated.

Republican lawmakers are set to reintroduce a bill to temporarily suspend the sale of Mifepristone/Mifeprex, most commonly known as RU-486, and launch an investigation into the process surrounding its approval in 2000 by President Bill Clinton.

Under the Clinton Administration, RU-486 was put on an accelerated approval process intended for experimental drugs in the treatment of life-threatening illnesses, of which pregnancy is not included. RU-486 was known to have serious side effects such as hemorrhaging and uterine rupture. Both were known at the time and still, the drug was approved.

The bill will ban the drug while the Government Accountability Office conducts a six-month investigation into the approval process the agency used previously before it determined that RU-486 was a "safe and effective" drug for women. If the FDA is found to have violated its own rules for drug approval, RU-486 will be banned indefinitely.

"This harmful and unethical drug was processed with a minimal amount of testing and short-circuited through the approval process due to political motivations. Kudos to Republican leadership in recognizing that RU-486 should be eliminated," says Dr. Pia de Solenni, Director of Life and Women's Issues with Family Research Council.

Earlier this week the Food and Drug Administration (FDA) announced that it would revise labeling for the drug RU-486, which was approved in 2000 under the Clinton administration because of reports of serious bacterial infection, sepsis, bleeding, ectopic pregnancies that have ruptured, and death.

Source: Family Research Council

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