Abortion-pill decision -poses complex problems for FDA,
WASHINGTON - Scientists have changed the face of the abortion debate in America, moving closer to offering a pill instead of surgery to women seeking to end their pregnancies.
But it's a complex step that involves making sure women, particularly the poor with no health insurance, actually visit a doctor three times to safely undergo a drug-induced abortion, and that doctors know how to use the controversial drug RU-486.
The Food and Drug Administration still must grapple with these issues as it tries to meet its goal of deciding RU-486's fate by mid September.
On Friday, the FDA's outside advisers recommended that the agency approve RU-486 after addressing the medical concerns.
"Obviously, there are serious concerns" about how RU-486 will affect women and their doctors, acknowledged FDA Commissioner David Kessler, who wouldn't say how he was leaning but who usually follows his advisers' recommendations.
The FDA is required to approve any drug found safe and effective if it also is properly manufactured. Such an inspection is yet to be done.
RU-486, known chemically as mifepristone, had a long road here. The drug is used by 200,000 European women, but its French manufacturer was blocked from selling it here by anti-abortion protests. A 1994 Clinton administration deal gave the non-profit Population Council U.S. rights to RU-486 so it could seek FDA approval.
A few U.S. doctors already use a cancer drug to induce abortions, but RU-486 could become the first FDA-approved abortion pill.
Opponents fear the agency's stamp of approval will make abortion more common. Surveys show many doctors who shun the outpatient surgery facilities required for today's abortions, which are targeted for picketing and even violence, say they might offer RU-486 in their private offices.
At least one top Republican has suggested that anti-abortion activists not focus their energies on RU-486.
"I'm not sure at a practical level how people are going to keep this out of the country," House Speaker Newt Gingrich told reporters yesterday.
He counseled the anti-abortion movement to instead concentrate on overturning President Clinton's veto of a bill that would ban certain late term abortions.
"My advice to everyone who is right-to-life is that the focus ought to be on partial-birth abortion,"Gingrich said in Marietta, Ga.
RU-486 defenders say abortions didn't increase when the drug was approved in France in 1988. AP