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
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
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.