Medical Groups Call on FDA to Use Scientific Evidence In Evaluating Availability of Early Abortion Option

5/24/2004

From: Alyssa Barnum of the National Abortion Federation, 202-667-5881; Web site: http://www.prochoice.org; or Erin Libit of Planned Parenthood(r) Federation of America, 202-973-4883, Web site: http://www.plannedparenthood.org

WASHINGTON, May 24 -- The National Abortion Federation (NAF) and Planned Parenthood(r) Federation of America (PPFA) today submitted to the FDA a joint response to a citizen's petition filed by the American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical Association, and Concerned Women for America. Their petition, which seeks the withdrawal of FDA approval of mifepristone (formerly known as RU-486) and requests restrictions on its use, lacks any scientific basis and must be denied.

The NAF and PPFA response is the most-up-to date, comprehensive and extensively referenced discussion of the proven safety of mifepristone. There is no medical reason to change the existing provider qualifications and protocols for ultrasound. The safety and efficacy of mifepristone has been proven time and time again. Since the FDA's approval of mifepristone in 2000, more than 250,000 American women have used mifepristone to safely terminate an early pregnancy.

"The FDA's decisions must be based on solid scientific evidence, not political pressure," said Vicki Saporta, president and CEO of NAF. "We have supplied the FDA with the latest medical facts and research on mifepristone. Our response proves that the current standards are in accordance with established medical practice."

Recently there have been concerns about the politicization of the FDA's decision-making process, specifically with its denial of over-the-counter availability of emergency contraception.

"Just two weeks ago the FDA ignored scientific evidence when failed to approve making emergency contraception available over the counter," said Gloria Feldt, president of PPFA. "We must not allow the FDA's decisions to continue to be compromised by anti- choice politics."

NAF and PPFA urge the FDA to get back to making decisions based on clear and concise medical evidence and to deny the unsubstantiated claims and unreasonable requests of the citizen's petition.

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The Executive Summary and the complete response can be found at: http://www.prochoice.org or http://www.plannedparenthood.org.



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