FDA fuels abortion pill debate

Possible restrictions on drug's use spur renewed activism

June 12, 2000|By Jean Marbella | Jean Marbella,SUN NATIONAL STAFF

It was once touted as a way to move abortion from the clinics, which attract sidewalk protesters and sporadic violence, and into the more private realm of a doctor's office or the patient's home. The so-called abortion pill would address both the personal and the political of a decades-long controversy - and perhaps begin to defuse it.

But the drug, more commonly known by its French designation, RU-486, remains mired in many of the same issues that arise when it comes to abortion. The U.S. Food and Drug Administration, which seemed on course to approve the pill later this year, is considering a series of restrictions that threatens to severely limit its use.

"RU-486 was supposed to profoundly change the debate about abortion. But that would only be true if the drug is approved for general use," said Lars Noah, a University of Florida law professor who specializes in FDA issues. "Otherwise, we're back to where we were before."

To abortion-rights activists, the fight over the abortion pill parallels the fight over abortion in general, and both sides are gearing up once again.

"The women's organizations have galvanized on this faster than anything I've seen," said veteran feminist Eleanor Smeal, speaking by phone as she left a weeklong women's conference at the United Nations, where the news about the proposed FDA restrictions were all the buzz.

Anti-abortion groups have long opposed mifepristone - the drug's generic name - for the same reason they oppose the surgical procedure. They welcome the proposed restrictions on the drug, although they would prefer an outright ban.

"We would not like it approved for this use, period, on the grounds that this is the life of an unborn child," said Laura Echevarria, spokeswoman for National Right to Life. "But there's such great potential danger to women's lives as well, for the FDA to do anything less than these restrictions wouldn't be wise. It should give women some pause. If the FDA is saying, OK, but ... American women have to rethink: Is this the safe abortion drug as it's been touted?"

Caught off guard

Activists were caught off guard last week when they learned that the FDA was considering restricting the use of mifepristone. The FDA, which was expected to approve the drug this fall, has proposed that only doctors trained to perform surgical abortions and have admitting privileges to an emergency room within an hour of their offices be allowed to prescribe the drug.

That would drastically limit the number of doctors who could prescribe the drug, a restriction that experts say is nearly unprecedented in FDA history.

"If they restrict it to only surgical abortion providers, there are already so few of them, so we've done nothing to increase accessibility of abortion," said Dr. Eric Schaff, a University of Rochester physician who heads the clinical trials of the drug.

Abortion-rights proponents are also alarmed by another measure the FDA is considering: creating a registry of doctors who are authorized to prescribe the pill

The registry, they say, would have a chilling effect similar to what exists. Doctors who have opted not to perform abortions because of personal safety concerns probably would be equally hesitant to have their names on a registry of mifepristone prescribers.

"We have a crisis of anti-abortion violence in this country," Katherine Spillar, national coordinator of the Feminist Majority, said of the shootings and bombings of providers and clinics. "Who can guarantee that this registry wouldn't get into the wrong hands?"

The battle for abortion rights was won in the courts with Roe vs. Wade in 1973, but now the issue is one of access.

The threat of protests and violence against abortion clinics has persuaded many physicians to opt out of performing the procedure - about 85 percent of U.S. counties lack an abortion provider. Anti-abortion groups have also sought - successfully, in many cases - to limit who can have an abortion. Various states have restricted the procedure by requiring parental approval for minors, establishing a waiting period or banning the procedure in the late term.

"There has been a strategy that has been used effectively by the anti-choice movement, this chipping away, this making what is legal accessible to as few women as possible," said Amy Allina, program director of the National Women's Health Network, a Washington-based advocacy group. "This fits within that strategy."

The proposed restrictions are the latest setback in what has been a long, rocky road toward getting mifepristone, long in use in Europe and China, approved for American women. France approved the drug in 1988, and soon other countries followed. But the FDA banned its import to the United States in 1989, a restriction that remained until 1993, when President Clinton issued an executive order directing the agency to reconsider.

Baltimore Sun Articles
Please note the green-lined linked article text has been applied commercially without any involvement from our newsroom editors, reporters or any other editorial staff.