March 1, 1995 in Nation/World

Republicans Caught In Fda Quandary Gop Wants Agency To Streamline Drug Approval, But Not For Ru-486

New York Times
 

The politics of abortion ran into the Contract With America on Tuesday, and Rep. Thomas J. Bliley Jr. of Virginia and more than a dozen other Republicans seem caught in the collision.

As chairman of the House Commerce Committee, Bliley is a leading Republican in the effort to ease regulatory burdens on businesses, particularly drug companies seeking quick approval from the Food and Drug Administration for new products.

But as an opponent of abortion he was the leading signer of a petition announced on Tuesday by an anti-abortion coalition urging the FDA not to relax its strict review standards for a French abortion drug, RU-486.

Americans United for Life, a group based in Chicago that opposes abortion, said at a Washington press conference that it had filed a citizens petition with the FDA demanding that it apply the strictest possible standards in reviewing the drug. The group argued that the agency should not use data from foreign studies, including those involving tens of thousands of women who used the drug in France and Great Britain.

Dr. Camilla Hersh, a physician and spokeswoman for the coalition, said doing so could contribute to “bad medicine and sloppy science that ignores women’s health and safety.”

But quickening the drug approval process is the kind of thing House Speaker Newt Gingrich of Georgia and his conservative allies have been pushing. Indeed, as Americans United for Life was urging in its press conference at the National Press Club that RU-486 face strict approval standards, at a press conference in an adjacent room the Competitive Enterprise Institute was urging that FDA approval standards be relaxed.

The institute and many Republican lawmakers have proposed loosening FDA rules to get drugs to the market sooner. Specifically, they have suggested allowing foreign approvals and foreign data to have weight in the United States.

Charles Boesel, Bliley’s press secretary, said on Tuesday that he was not aware that his boss had signed on to the petition urging strict FDA standards for RU-486. He said that Bliley had not decided what proposals he would support in changing the FDA standards and practices and that it was still a time of learning for the Republicans who are now running Congress.


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