Bush FDA Nominee Cites Safety Concerns Over RU-486

By Christine Hall | July 7, 2008 | 8:29pm EDT

(CNSNews.com) - Obstetrician W. David Hager Tuesday said his opposition to the abortion drug RU-486 is based on safety considerations and inadequate testing, not his position on abortion.

The Christian physician is under consideration by the Bush administration to head the Food and Drug Administration's Reproductive Health Drugs Advisory Committee and has been the subject of controversy among liberals who oppose his nomination.

Even though the committee's most immediate task will be to consider issues related to hormone replacement therapy, Hager's pending appointment has drawn criticism from groups who claim he will try to hinder FDA approval of certain drugs and medical devices and make abortion more difficult to obtain. Hager is pro-life.

Speaking at a Capitol Hill forum hosted by Concerned Women for America, he made no secret of the fact that he thinks the FDA flouted its normal drug approval process in approving abortion regimen RU-486, also known as Mifeprex, in September 2000.

"This certainly violated the general trend," of drug approval, said Hager, who thinks the drug should be withdrawn from the market until further tests can be conducted to determine whether the drug is safe.

Short of pulling the drug from the market, he said the FDA should amend RU-486 regulations to restrict its use to adult women and require that doctors administer an ultrasound to determine whether there is a uterine pregnancy.

If an ultrasound doesn't show a uterine pregnancy, that's a signal to the doctor to check for an ectopic (fallopian tube) pregnancy, which cannot be terminated by use of RU-486 and can be fatal if left untreated.

Because RU-486 causes some of the same symptoms as do ectopic pregnancies, like bleeding and cramping, Hager and other doctors fear that the ectopic pregnancies will go untreated, causing injury or death.

He and other critics of RU-486 say that the final FDA regulations do not track with precautions taken during the French and American drug trials. For example, the trials did use ultrasounds on patients, a practice that is optional under current FDA RU-486 regulations.

And adolescents did not participate in the two trials, yet the FDA waived the so-called "pediatric rule" that requires testing on children and adolescents before a drug is approved for their use.

Concerned Women for America joined the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), and the Christian Medical Association, of which Hager is a spokesman, in petitioning the FDA to halt all distribution and marketing of the RU-486.

"FDA, in approving Mifeprex, acted in a manner inconsistent with its statutory authorization, regulations and well-established policies," commented Dr. Donna Harrison, speaking for AAPLOG.

"The approval of Mifeprex was...arbitrary, capricious [and] an abuse of discretion," said Harrison. "It must be reversed."

Two groups most responsible for introducing Mifeprex to American consumers, Danco Laboraties and the Population Council, have both defended the abortion drug, calling it safe and effective.

"Every aspect of the drug's manufacturing, marketing and distribution was reviewed by the FDA prior to approval," a Danco spokesperson told CNSNews.com in April. "We fully stand behind the safety and efficacy of the Mifeprex regimen."

The status of Hager's appointment was uncertain Tuesday. Hager himself declined to comment on it, referring such inquiries to FDA Deputy Assistant Secretary for Public Affairs Bill Pierce, who did not return calls seeking comment.

Spokespeople for Planned Parenthood and the Coalition for Reproductive Choice said they did not know of any decision reached by the administration.

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See Earlier Stories:
Abortion Rights Groups Target Doc On Religious, RU-486 Views (Oct. 15, 2002)

Pro-Life Groups Petition FDA To Revoke RU 486 Approval (Aug. 21, 2002)

Liberals Decry Religious Influence In Health Policy (Oct. 23, 2002)

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