Ten years after the FDA's politically streamlined approval of the RU-486 abortion pill, an abortion advocate tells USA Today, "It's unlikely that mifepristone [RU-486] will ever completely replace early surgical abortions."
A decade of experience with RU-486 clearly shows why: The powerful pill can be as deadly to the mother as it is to her developing baby.
The FDA acknowledges that since it approved the chemical abortifacient in September 2000, the agency "has received reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death. Those reports led to the revision of the black box labeling."
Commonplace off-label uses of the pill further intensify the risks to women's health and lives. Abortion clinics that prescribe RU-486 for home use put women at risk, because it is too difficult to distinguish the pain and bleeding that typically accompany RU-486 from similar symptoms that foreshadow fatal septicemia.
A recall petition document filed in 2002 with the Food and Drug Administration by physicians and women's advocates chronicles how politically pressured FDA officials ditched the agency's own well-established standards in accepting poorly constructed RU-486 trials that were not blinded, randomized, or concurrently controlled (see also 21 C.F.R. § 314.126). The FDA also inexplicably waived its rule requiring the testing of all new drugs for their potential effects on children and teens (see also 21 C.F.R. § 314.55).
Advocates on both sides of the abortion debate should agree that in the interest of patient safety, the FDA must objectively evaluate drugs based on medical evidence--not political pressure.