GOP lawmakers seek to restrict who can dispense abortion pill

WASHINGTON (CNN) -- Two Republicans introduced legislation Tuesday that would tighten controls over who can provide patients with the abortion pill that won federal approval last September.

"We believe these are reasonable protections for women's health," said Sen. Tim Hutchinson, R-Arkansas. "This is not an effort to roll back and repeal the FDA approval. We believe safety concerns were compromised."

Rep, David Vitter, R-La., is House sponsor of the bill, known as the RU-486 Patient Health and Safety Act.

Some Republicans want to repeal the Food and Drug Administration approval of RU-486. Health and Human Services Secretary Tommy Thompson wants to review the drug, but he says he will not restrict its use unless he receives new data showing it is harmful beyond what the FDA knew at the time it was approved.

Abortion rights groups, including Planned Parenthood and the National Abortion Federation, oppose the bill, calling it another effort to restrict abortions.

"If these restrictions were necessary, the FDA would have promulgated them in the first place," Planned Parenthood President Gloria Feldt told CNN Tuesday. "The FDA knows how to evaluate scientific information. Congress knows nothing about that."

The new GOP legislation would require physicians prescribing mifepristone and misoprostol to be qualified to handle complications of an incomplete abortion and to be trained to perform a surgical abortion if needed. Physicians also would be required to have admitting privileges at a nearby hospital in case of complications such as excessive bleeding.

Currently the FDA requires only that abortion pill providers have plans in place to refer a woman for a surgical abortion if the medical abortion is incomplete. It also requires that they be able to tell how far along pregnancy has progressed. The bill would require that physicians be able to read a sonogram in order to date the pregnancy and identify an ectopic pregnancy.

"The FDA is not mandating the use of a sonogram," Hutchinson said. "That's too much laxness. A sonogram is the only accurate and proper way to evaluate a pregnancy."

Opponents of the legislation say it is extreme.

"Doctors who currently perform surgical abortions do not have to have any of these qualifications," said Dr. Richard Hausknecht, associate professor of obstetrics and gynecology at Mount Sinai School of Medicine. Hausknecht also is a consultant with Danco Laboratories, which distributes mifepristone in the United States.

"Some doctors who perform surgical abortions have hospital admitting privileges and can perform sonograms, but some don't."

Hutchinson also raised concerns about the safety of mifepristone, which he says is manufactured by a Chinese firm. Neither the FDA nor Danco Laboratories has identified the actual manufacturer.

"I understand the manufacturer has a spotty record of safety," said Hutchinson "and has been taken to task by the FDA in the past for tainted drugs. There's no evidence this is the case with RU-486, but it needs to be monitored."

Danco Laboratories points out a number of drugs supplied to patients in the United States are manufactured overseas.

"We've inspected the plant several times," said Hausknecht, "and we've repeatedly tested the drug when it's arrived in the United States and there is not a shred of evidence that the drug supplied by Danco to American women is anything other than what it is supposed to be."

Once an FDA ruling is finalized, the only way to undo it is through legislation. However, a spokeswoman for the agency said it's unprecedented for Congress to overrule an FDA decision.

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