The Christian Medical Association is fighting efforts by Planned Parenthood and the National Abortion Federation this week to persuade the FDA to dismiss evidence the abortion drug RU-486 should be taken off the market and given a new and proper safety review.
"The economic incentives of abortion and the drive to expand access and the market for abortion seem to have driven a biased assessment by these groups of the scientific evidence," said CMA Associate Executive Director Gene Rudd, an obstetrician and gynecologist.
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In August 2002, the Christian physicians, and two other groups, submitted a 90-page citizen petition to the FDA presenting evidence the drug had not been proven safe and was rushed to the market in a politically pressured decision.
The abortion groups filed their objections to the citizen petition with the FDA this week.
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They claim the petition "lacks any scientific basis and must be denied."
"The FDA's decisions must be based on solid scientific evidence, not political pressure," said Vicki Saporta, president and CEO of the National Abortion Federation. "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."
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CMA developed the petition with Concerned Women for America and the American Association of Pro-Life Obstetricians and Gynecologists.
"Our citizen petition raised ample scientific concerns regarding the adverse health implications of mifepristone to justify re-evaluation and removal of this product," Rudd asserted.
"Safety concerns were not adequately taken into account during initial evaluation," he continued. "Sadly, these and new concerns have been realized since the regimen went into use."
Rudd said U.S. experience with the drug has resulted in numerous untoward effects, including the recent tragic death of Holly Patterson in California.
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The drug regimen works in two stages, first killing the unborn child then inducing labor. Critics point out women prescribed with the drug often are sent home with no medical supervision and knowledge of the effects.
"There is additional concern of gross underreporting of bad outcomes with this drug, as the FDA relies on the very individuals and groups that are likely guilty of abuse and negligence to report their own wrongdoing," Rudd said.
The abortion advocates contend the FDA's decision will be biased by "politics."
Rudd insists this "is nothing more than a strategy to distract attention away from valid scientific concerns and an attempt to bully the FDA."
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Politics during the previous administration is what drove the FDA not only to approve this drug, but also to drop vital requirements it had developed to mitigate the drug's danger," he said.