Clinton FDA used norms in abortion pill approval

A new report issued Monday deals a blow to anti-abortion-rights activists by finding the Clinton administration approved the abortion pill known as RU-486 using its standard procedures.

{mosads}The study, issued by the Government Accountability Office (GAO), does not support activist contentions that the Clinton White House politically interfered with the approval process for RU-486, called Mifeprex or mifepristone in the United States.

GAO auditors compared the process used for the abortion pill to that used for other drugs that were approved during the same time period under expedited review but for limited distribution through medical specialists under “Subpart H.”

The report concluded that, at all stages, the Food and Drug Administration’s (FDA) actions to allow mifepristone on the market were “consistent” with those for the other medicines.

“[T]he approval process for Mifeprex was generally consistent with the approval processes for the other eight Subpart H restricted drugs,” the report states.

The purpose of the drug is to terminate early pregnancies; it had been on the market in other countries for more than 10 years before gaining U.S. approval. After four and a half years and three reviews, the FDA approved the abortion pill in September 2000, four months before Clinton left office and was replaced by President Bush.

More than 915,000 women in the United States have used mifepristone since it became available.

Three Republican lawmakers who oppose abortion rights requested the GAO investigation: Senate Health, Education, Labor and Pensions Committee ranking member Mike Enzi (Wyo.), Sen. Jim DeMint (S.C.) and Rep. Roscoe Bartlett (Md.).

Enzi’s, DeMint’s and Bartlett’s offices were not immediately available for comment.

All three lawmakers have sponsored legislation to ban mifepristone, though there is no Senate bill pending in the 110th Congress. The bills were introduced after six women in the United States died of blood infections after using a regimen of mifepristone that, while commonly used, is not the FDA approved method. The FDA and the Centers for Disease Control and Prevention, however, have not conclusively linked the drug to those deaths.

Critics of the FDA’s actions have focused their complaints on three areas: that the agency did not demand enough clinical evidence of the drug’s safety and effectiveness; that the agency inappropriately used an approval process intended for drugs to treat “serious or life-threatening conditions”; and that the FDA failed to adequately react to serious or fatal side effects that may be linked to mifepristone.

The GAO’s conclusions are limited to stating that the FDA followed its own standard procedures during the course of its review of the abortion drug.

The FDA used the same process to approve more than 50 other drugs currently available with limited distribution because of their potential for serious side effects, such as thalidomide and the acne pill Accutane.

Federal agencies often respond to the GAO with comments criticizing its conclusions, but the Department of Health and Human Services, of which the FDA is a part, offered only technical comments to the report.