FDA fuels abortion pill debate; Possible restrictions on drug's use spur renewed activism

THE BALTIMORE SUN

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.

In the summer of 1996, the FDA held hearings on mifepristone, and its advisory committee recommended that it be approved. That September, the agency determined that the drug was safe and effective for early termination of pregnancy and requested additional information on how it would be manufactured and labeled before being granted final approval.

But political pressures have had their effect over the years: The French company that developed the drug refused to distribute it in the United States for fear anti-abortion groups would boycott its other products. And no U.S. company would agree to manufacture it. The Population Council, a nonprofit reproductive rights group, which was granted U.S. rights to the drug, worked out a deal with a start-up company, Danco Laboratories, to manufacture and distribute mifepristone under highly secret circumstances to prevent protests and violence.

In February, the FDA indicated that it had several questions that needed to be answered before granting final approval, and many activists believed the process was on track and the drug would soon be made available. But this month, Danco officials told a meeting of abortion-rights proponents that the FDA was proposing a set of restrictions on who can prescribe the drug.

The severity of the restrictions was the biggest surprise. "The FDA doesn't typically regulate the practice of medicine," said Schaff, the Rochester physician.

Generally, drugs are approved or disapproved; only rarely are there restrictions on how doctors can use them, said Noah, the Florida law professor.

He could only think of two drugs- thalidomide, a sedative used in the treatment of AIDS and leprosy; and Acutane, an acne medication - that went into the marketplace with severe restrictions on their use because of the danger of birth defects.

"Thalidome and Acutane, those are unusual examples," Noah said. "The agency is telling the manufacturer you may not sell this to anyone just because they have a medical license. That's almost never done."

He and others suspect politics has entered into the approval process. The FDA has refused to comment.

"When I heard the news, I thought, here is politics trumping science," Noah said. "It wouldn't surprise me if this wasn't a reflection of concern that, without some sort of concessions, all political hell will break lose - and in an election year."

Medical standpoint

Proponents of the drug say that strictly from a medical standpoint, there should be no question over the drug's approval.

"This drug - you can't get addicted to it, there are almost no side effects, and yet we are treating it like the most dangerous drug in the world," Schaff said.

Thousands of American women have used the drug in trials at 15 abortion clinics across the country. Doctors say the drug can be used as soon as a woman learns she is pregnant and up to the seventh week. And women also like the fact that the drug can be used at home rather than in a clinical setting, doctors say.

Mifepristone works by blocking a hormone that is necessary to maintaining a pregnancy. It is used in conjunction with a second drug, misoprostol, which causes contractions that serve to expel the embryo. In some cases, the drugs do not result in a complete abortion, and then a surgical abortion is necessary. Surveys of women who have used the drugs show that more than 90 percent would recommend this method of terminating pregnancy. Abortion-rights supporters say they remain optimistic that the drug will be approved without the restrictions.

"I always believe the goodness of science will win out," said Dr. Elizabeth Newhall, a Portland, Ore., physician who is involved in the drug's clinical trials. "We have a method that is 98 percent effective, with very small and acceptable risks. The safety and the efficacy are not the issue.

"But the reality is there are always other issues with abortion."

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