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Regulatory Issues

Groups seek to bar abortion pill

Published in Medical Letter on the CDC and FDA, September 22nd, 2002

Antiabortion groups petitioned the U.S. Food and Drug Administration August 21, 2002, to halt sales of the abortion pill Mifeprex, saying the agency shouldn't have approved it almost 2 years ago.

The American Association of Pro-Life Obstetricians and Gynecologists, Christian Medical Association and Concerned Women for America argued that FDA bent its own rules in approving Mifeprex, including eliminating safeguards required during the pill's testing.

The groups called the drug dangerous for women, citing FDA's report last April of five Mifeprex users with health problems, including two who suffered ruptured ectopic pregnancies, one fatal.

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