Activists Brace for FDA's Decision on Abortion Pill
WebMD News Archive
But a more likely consequence probably will be the passage of rules limiting the use and distribution of RU-486. In June, the FDA confirmed that it was considering a set of restrictions that would -- among other things -- require physicians prescribing the drug to have admitting privileges in hospitals and be able to conduct a surgical abortion.
If passed, the rules effectively would stifle one of the most promising benefits to this drug, Chavkin tells WebMD. As is, RU-486 offers the opportunity for women to avoid harassment and violence because the abortion can be done in the doctor's office rather than an abortion clinic, Chavkin explains. But if the restrictions are passed, many health care providers will not be able to offer the drug -- especially in rural areas where access to hospitals is limited -- or to prescribe the drug due to their lack of experience with surgical abortions, she says.
"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.