WASHINGTON — Although the issue has been lightly mentioned on the campaign trail, whoever wins next month's presidential election could play a significant role in whether and how U.S. women have access to RU-486, the abortion pill.
The drug was approved by the Food and Drug Administration on Sept. 28 after four years of study, including a review of clinical trial data involving more than 2,000 women. It could reach doctors in about a month.
The drug has been available in much of Western Europe for a decade. But the next president could try to limit its U.S. distribution or reverse the FDA's decision altogether.
That is unlikely to happen if Vice President Al Gore, the Democratic nominee, is elected. A supporter of abortion rights, Gore has said he backs distribution of the drug now that the FDA has found it to be safe and effective.
The Republican ticket, by contrast, has expressed disapproval of the FDA decision. However, both Texas Gov. George W. Bush, the presidential nominee, and his running mate, former Defense Secretary Dick Cheney, have turned aside questions about what they might do to limit distribution of the drug.
Specialists in administrative law say that a president cannot unilaterally overturn an FDA decision. But the FDA commissioner, who is a presidential nominee, can order a review of a drug approval based on how it is affecting consumers. And where reports of patient problems may seem minor to one FDA commissioner, another might see those reports as significant enough to warrant limitations on the drug or its removal from the market.
On the day of the FDA approval, a spokesman for the Bush campaign said that the governor, if elected president, would order a "careful review" of the FDA decision.
Bush himself said something different about the drug approval during his debate Tuesday with Gore.
Moderator Jim Lehrer of PBS asked: "You wouldn't, through appointments to the FDA, ask them to reappraise it?"
"No," answered Bush. "I think once the decision's been made, it's been made. Now--unless it's proven to be unsafe to women." He did not elaborate on that comment.
The issue also arose Thursday in the vice presidential debate between Cheney and his Democratic counterpart, Sen. Joseph I. Lieberman of Connecticut. Moderator Bernard Shaw of CNN asked whether the candidates would support legislation filed by Republicans in Congress last week that would limit the distribution of RU-486.
Lieberman said he did not support the bill. Cheney said he had not seen the legislation, and he offered no opinion.
Under that legislation, introduced by Sen. Tim Hutchinson (R-Ark.) and Rep. Tom A. Coburn (R-Okla.), doctors who offer the pill would have to know how to perform surgical abortions, hold admitting privileges at a hospital no more than an hour from their offices and meet other conditions. In contrast, the FDA said almost any doctor could offer RU-486, which is known as mifepristone.
The lawmakers say their aim is to protect women and make sure doctors are prepared to handle any emergencies that may arise from the use of the drug. Abortion rights groups say the legislation would unnecessarily limit the pill only to those clinics where abortion is provided today.
In a conference call with reporters Friday, organized by the Gore campaign, former FDA Commissioner Dr. David A. Kessler said that the Bush-Cheney ticket is being "evasive and contradictory" in its position on RU-486.
"When you listen to both Gov. Bush and Secretary Cheney, they were very evasive on the central question: Would they be willing to veto legislation passed by a Congress that would overrule FDA's decisions?" said Kessler, who was named FDA chief in 1990 by President Bush, the father of the Texas governor, and who continued to serve under President Clinton.
Kessler, now dean of Yale's medical school, said that the most likely attack on the FDA's decision would come in the form of congressional legislation to block the pill's distribution. "I think George Bush and Dick Cheney owe it to the women of this country as to whether they would back this overturning of RU-486," Kessler said.
Martelle reported from Los Angeles. Times researcher Massie Ritsch contributed to this story.