Activists Brace for FDA's Decision on Abortion Pill
"It's not normal for the FDA to impose this kind of micromanagement," adds Chavkin, while noting that under normal circumstances, physicians usually are permitted to prescribe almost any drug regardless of their specialty.
Short of being able to block the approval of RU-486, it is this set of restrictions that anti-abortion rights groups are likely to pursue, Cirmo confirms. "First and foremost, we are against all abortions," she tells WebMD. However, at a bare minimum, the group would accept these restrictions as sort of a temporary compromise, she says.
The RU-486 abortion process is similar to having a miscarriage, during which there could be cramps and bleeding, Cirmo explains. "Women are not always informed about that process," she says, noting that the drug also is not an easy fix for the emotional trauma that often accompanies an abortion.
Still, there is a chance that the drug will be approved with no restrictions even as a treatment for other disease conditions. It also has been used to treat glaucoma, Cushing's syndrome, various tumors, and to induce labor. In 1995, RU-486 was shown to inhibit the growth of cancer cells and the activation of a receptor that plays a role in the reproduction of HIV, the AIDS virus. Once approved for these indications, physicians could legally use the drug to induce abortions as well.
Over the summer, FDA officials backed down on a number of the initially proposed set of restrictions, says Sandra Waldman, a spokeswoman for the Population Council, the nonprofit group and owner of the RU-486 patent. "I wouldn't anticipate anything," Waldman says. "We have had very positive discussions."
And, argues Chavkin, there is little merit to the FDA's safety concerns. The majority of women are unlikely to use an abortion pill more than once in their lifetime and the side effects, while possibly severe, generally are quickly resolved, she tells WebMD. Considering the drug's risk and benefit profile, "American women will not tolerate being deprived of this important option," Chavkin says.
But because of past blunders, pro-choice groups such as the National Abortion Rights Action League (NARAL) are taking no chances. Politics historically has surrounded the process and, as a result, the group is making a concerted effort to ensure that people see the approval as a political issue, Betsy Cavendish, JD, legal director of NARAL, tells WebMD.
"If Bush is elected, it could be the end of the day. We can't take that chance," Cavendish says. "Women deserve to have access to the full range of reproductive options."
Anti-abortion rights groups also are making special preparations for the day-after battle. That fight will take place on a number of fronts, Cirmo assures WebMD. For example, in the early 1990s, anti-abortion rights forces even managed to convince the drug's French developer, Roussel Uclaf, to abandon the drug by boycotting its other products, she points out.