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FOR IMMEDIATE RELEASE

June 28, 2000

CONTACT

Communications Department
202-667-5881

National Abortion Federation Responds to FDA's Suggested Restrictions Regarding Final Approval of Mifepristone (RU-486) for Early Abortion

Las Vegas, NV - At a press conference today in Las Vegas about their public service campaign currently running there, the National Abortion Federation (NAF) spoke out about the FDA's suggested requirements for final approval of mifepristone. "This latest development in the ongoing approval process for mifepristone has nothing to do with medicine, and everything to do with anti-choice politics," said Vicki Saporta, Executive Director of NAF. "If the restrictions currently being considered by the FDA are put into place, fewer physicians will be able to administer mifepristone, fewer women will be able to access this safe early abortion option, and the promise of mifepristone will not be realized."

"The restrictions currently being considered by the FDA are so stringent that some even exceed the requirements of the clinical trials," continued Saporta. "It has long been recognized that there are usually many requirements put into place during clinical trials, most of which will not be required after final FDA approval when a drug's safety has been established. The fact that the FDA is suggesting restrictions that were not in place during the clinical trials of mifepristone is contradictory, and not justified by medical considerations. It has been four years since the FDA ruled that mifepristone is safe and effective in inducing early abortion. And in the last decade, millions of women in over 20 countries worldwide have used mifepristone safely."

Referring to the FDA's suggested requirement that physicians are trained and certified in administering mifepristone, Saporta said, "We are in favor of physicians receiving training in providing mifepristone abortions. In fact, as the only organization that provides an ongoing program of accredited continuing medical education on abortion, NAF has already held numerous educational seminars on early medical abortion this year, and has educated more than 1,000 health care providers in this option. Just last month we launched a new web site on early medical abortion, www.earlyoptions.org, to provide information about medical abortion and outline resources that NAF will make available to health care professionals who plan to offer this option to their patients once mifepristone receives final FDA approval."

"While training is important, a third party certification of such training should not be an FDA requirement," said Saporta.

Saporta also cautioned that incorrect information has been reported about some of the restrictions that have been suggested by the FDA. "To our knowledge, the FDA has not proposed a national registry of mifepristone providers. We would strenuously object if such a proposal were made. However, we are extremely concerned by the other restrictions that we understand have been suggested by the FDA."

"If those requirements are put into place, the ability of physicians to provide this safe option will effectively be curtailed, and American women will have difficulty in accessing this safe health care option that women around the world already have."

"The FDA is supposed to make their decisions based on scientific evidence, and we expect that in the end that is what their decision regarding mifepristone will be based on - not on politically motivated restrictions," said Saporta.

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The National Abortion Federation is the professional association of abortion providers in the U.S. and Canada dedicated to ensuring that abortion remains safe, legal and accessible.
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