, 2000

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JUNE 8, 1999  6:08 PM
William J. Lutz of NARAL, 202-973-3032
Congress Blocks FDA Approval of RU-486
WASHINGTON - June 8 - The following was released today by NARAL:

European women have had access to it for over a decade. If anti-choice lawmakers in the House have their way, American women never will. It is mifepristone, commonly known as RU-486, a safe and effective nonsurgical early abortion method in use in Europe since 1981.

Anti-choice lawmakers in the House, led by Rep. Tom Coburn (R-Okla.), today passed an amendment to the FY00 Agriculture Appropriations bill that prevents the Food and Drug Administration (FDA) from using government funds to approve the use of drugs that induce medical abortion, including mifepristone. The move by anti-choice lawmakers effectively closes the door on this important reproductive health option for American women and comes just as the FDA was expected to give final approval to the mifepristone later this year. The FDA issued an "approvable letter" for the use of mifepristone for early abortion in September 1997, but is awaiting more information about its manufacture and labeling before giving final approval.

"Mifepristone and other similar medical advancements would greatly expand women's choices and allow them to make those choices in a safe, private environment, away from the harassment, violence, and intimidation that occurs outside of clinics," said NARAL President Kate Michelman. "It is no surprise that those who seek to ban abortion and limit women's options would target this highly safe, private, and effective abortion method."

Mifepristone was approved for use in Europe following extensive clinical trials that demonstrated is safety and effectiveness. It has since been used safely by over 500,000 European women. U.S. clinical trials have yielded findings similar to European trials. Mifepristone and other similar drugs are effective for terminating early pregnancies up to 49 days from the beginning of a woman's last menstrual cycle. They have also shown promise in the treatment of a wide variety of other medical conditions, including breast cancer, HIV, Cushing's syndrome, and endometriosis.

"The FDA is charged with assessing the safety and effectiveness of drugs before they are made available to the American public," said Michelman. "Anti-choice lawmakers are imposing their political agenda on the FDA and have consequently shut the door on what promises to be an important medical advancement for the American public. Science should be the basis for the FDA drug approval process, not politics.


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