SUNDAY
February 11, 2001
volume 12, no. 42

Clinton Administration Bent Rules in Approving RU-486



    WASHINGTON, DC, Feb. 9, 01 (CWNews.com/LSN.ca) - The US Federal Drug Agency allegedly approved the abortion drug RU-486 (mifepristone) last September after bending regulations concerning so-called fast-track approval.

    The National Review (NR) web site reported that mifepristone was approved under a fast-track drug-approval process intended only to be used, according to FDA regulations, for safe and effective treatments "for serious or life-threatening illnesses."

    The drug was approved in a memo from an unnamed FDA official to Sandra P. Arnold, the Population Council's vice president of corporate affairs, on September 28. In the memo, the FDA stated that mifepristone should enjoy the benefit of this provision because "the termination of an unwanted pregnancy is a serious condition within the scope of [the fast-track regulations]."

    NR reported that until RU-486, only 30 drugs had ever been approved under the fast-track exception-- half of those being for the treatment of HIV/AIDS and the rest for other debilitating diseases, such as cancer, tuberculosis, and leprosy.

    As for the requirements of safety and effectiveness these too are unfulfilled with mifepristone. An FDA study found mifepristone abortions caused "more adverse events, particularly bleeding, than did surgical abortion."

    Other side effects to the abortion drug including cramping, nausea, and vomiting, were far more prevalent among the women taking RU-486 than among women undergoing regular abortions.


February 11, 2001
volume 12, no. 42
Pro Life News
www.DailyCatholic.org
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