AMA and ACOG to FDA: No "Restrictions" on RU486

Abortion pill supporters who have mounted a campaign against reports that the Food and Drug Administration (FDA) will propose some limits on the use of the abortifacient RU486 gained support when two of the nation's largest physician's groups came out against the regulations.

In a July 24, 2000, letter to FDA Commissioner Jane Henney, the American Medical Association (AMA) and the American College of Obstetricians and Gynecologists (ACOG) expressed their concern about possible "restrictions" on mifepristone (RU486) the FDA is said to be considering proposing regarding distribution and administration.

The letter does not discuss any particular regulation the FDA is supposed to be considering, but says generally that the " requirements are not based upon scientific facts, do not follow current medical practice, and impose inappropriate conditions on the practice of medicine."

An ACOG press release issued in conjunction with the letter lists five particular proposals ACOG would have issue with: limiting distribution to licensed physicians, requiring that prescribing physicians be trained in providing surgical abortion, requiring prescribing physicians to have certification in ultrasound dating of pregnancy and detecting ectopic pregnancy, requiring physicians to have training in administering mifepristone, and requiring prescribing physicians to have admitting privileges at a hospital within an hour of their offices.

While the ACOG complains that the first requirement "interferes with state medical, pharmacy, and nursing scope laws," its basic complaint with the last four proposed regulations is that they are "not necessary to administer mifepristone 'safely and effectively,'" or "not necessary to administer mifepristone 'safely and correctly,'" or that the given regulation is simply not required to administer the drug "safely."

In addition, it claims that ultrasound certification is "not related" to prescribing the drug, that the FDA has no training curriculum in place, and that the prescribing physician is not needed for follow-up emergency care.

Authors of the letter and the press release indicate no awareness of the proven risks and dangers that accompany the use of this two-drug chemical abortion technique and about which there are still a lot of unanswered questions. For example, what will a doctor with no surgical experience do when faced with an incomplete or "unsuccessful" RU486 abortion? How will a physician determine which of his patients has an ectopic pregnancy without ultrasound?

How will a physician react when he sees a woman doubled over in pain and gushing blood in his office bathroom? How will a physician handle the complications that often accompany chemical abortion and put at least one out of every 50 women in the hospital? What will a doctor do with a woman who is bleeding to death, like the Iowa woman who almost died, participating in the U.S. trials?

The letter requests a meeting with Henney and her staff to discuss the issue and says, "It's imperative that the FDA fully understands the effect that these proposals would have on the quality of health care." In a not-too-subtle dig at the FDA's motivation and objectivity, the letter also declares, "It's equally imperative that the FDA's work be based solely on evidence from the drug's clinical trials and be entirely free from any political influence."

Given the evidence of dangers from the clinical trials, and the basic fact that chemical abortion turns health care on its head, making medicine a killing, rather than a healing profession, it might seem wise for the ACOG and the AMA to apply these principles to their own positions.