No More FDA Waffling on Pill

At least half a million European women have safely used the RU-486 abortion pill since the drug combination was developed in the 1980s, but partisan politics continue to keep the French pill off-limits to American women. The U.S. Food and Drug Administration, still discussing whether and how to permit the pill’s use, should give Americans this safe option to surgical abortion without further equivocation.

Years of testing have conclusively shown mifepristone, otherwise known as RU-486, to be safe and effective--two requirements for FDA approval. The pill, taken in early pregnancy, has obvious advantages over surgical abortion, including a lower risk of complications and the fact that it is administered in a doctor’s office or at home.

Women would no longer face jeering protesters at clinics or hospitals or fear the clinic bombings of recent years, which have caused a snowballing number of doctors who perform the procedure to shutter their clinics. One of every four women who choose to terminate a pregnancy now has to travel more than 50 miles to do so. RU-486 would expand access to abortion very early in pregnancy--up to seven weeks--while removing women and physicians as targets of violence. The decision to have an abortion becomes what most Americans believe it should be: a private matter between doctor and patient.

Those very advantages have ensnared the FDA’s approval process in fierce politics between antiabortion and pro-choice forces. As a Sept. 30 deadline for action looms, the FDA, which had inched toward approval, appears to be backtracking, suggesting unwarranted and nonsensical restrictions on the use of the pill.

For example, the FDA reportedly wants only doctors who perform surgical abortions to be permitted to prescribe mifepristone. These doctors would also have to be affiliated with hospitals less than an hour’s travel time away.

In essence, RU-486 causes a miscarriage, not unlike those that many women spontaneously experience early in pregnancy. Because gynecologists, internists and family practitioners--including those who practice far from a hospital--routinely treat women who miscarry, the FDA’s proposed restrictions are not warranted.

Science should govern the FDA’s decisions on RU-486. There should be no more waffling.