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Abortion Pill Could Be in the Hands of the Voters

Although FDA approval on RU-486 is pending, whomever the public elects as the next president will play a major role in the drug's future.


WASHINGTON — When the nation's voters go to the polls in November, they may help decide, perhaps unknowingly, whether American women will have access to RU-486, the "abortion pill" that is already available in most of Western Europe as well as Israel and China.

The Food and Drug Administration is expected to rule by Sept. 30 whether the drug, available for more than 10 years in France, can be marketed in the United States or whether more review is needed. Many people following the case expect the FDA to approve the drug, though regulators could impose restrictions that might limit its availability, especially in rural areas.

Still, no matter how the agency rules, the next president will have broad powers that he could use in an attempt to reverse the FDA decision on the drug or to alter the rules for its distribution.

The presidential campaign already has highlighted the sharp division on abortion between Texas Gov. George W. Bush, the Republican nominee and an abortion opponent, and Vice President Al Gore, the Democratic nominee, who supports access to the procedure. Much attention has gone to how each man might remake the Supreme Court to bolster or undermine Roe vs. Wade, the landmark case that guaranteed a woman's right to abortion.

But as the RU-486 debate shows, there are several less visible areas where the president could have a direct effect on abortion policy and related matters without appointing a single justice.

Last month, for example, officials at the National Institutes of Health said that they soon would approve the first-ever federal funding for medical research using cells from human embryos, which are destroyed in the process. Bush opposes the research on moral grounds, and as president he could block the NIH with an executive order. Gore supports the research, saying that it could lead to cures for diabetes, Parkinson's disease and other ailments.

Similarly, the next president could issue executive orders that affect the availability of abortion counseling at family planning clinics that receive federal funds. And the president could order the next attorney general to toughen or relax enforcement of a federal law that bars protesters from blocking access to abortion clinics.

"It's not just a matter of whether he will get two more votes to reverse Roe vs. Wade. There's a lot of detailed policy-making where the president enjoys discretion," said Richard J. Pierce Jr., a specialist in administrative law at George Washington University.

RU-486 could prove to be one area in which the executive branch exerts its influence. Although the FDA prides itself on considering only the scientific evidence in a drug-approval decision, "clearly, the mind-set of the administration can play a role in how hard they look at certain issues," said Douglas Johnson, legislative director of the National Right to Life Committee.

In fact, the White House has long had a strong influence on the drug's course in the United States. RU-486 was invented in France and approved for use there in 1988. But the administration of President Bush, the Texas governor's father, barred its import to the United States for personal use, saying it had not been adequately studied and its widespread use could lead to health problems. This was a signal that the administration would be hostile to any company's attempt to put the drug on the market. Only days into his first term, President Clinton asked the FDA to consider reversing that policy and to take other steps to begin the process of assessing it for use by U.S. consumers.

In 1994, the French manufacturer donated U.S. rights to RU-486 to the Population Council, a New York-based nonprofit group focusing on reproductive rights, which in turn has licensed Danco Laboratories to arrange for all manufacturing, marketing and sale of the drug.

In 1996, the FDA reviewed data from clinical trials and determined that RU-486 is safe and effective, but it has taken Danco several years to find a manufacturer and satisfy FDA questions on labeling and other apsects of the drug's distribution. The decisions expected this month concern the standards for manufacturing, labeling and marketing.

In the meantime, both opponents and supporters of abortion are trying to assess what role the next president could play in shaping the drug's future.

Bush, who opposes abortion except in instances of rape, incest and when the mother's life is in danger, opposes the sale or use of RU-486, said Ray Sullivan, spokesman for the Bush campaign. However, he said, the campaign would not "speculate" about any actions Bush might take to prevent the approval of RU-486 for sale or to remove it from the market.

Gore has said that he would support a woman's right to choose abortion and that he would not block the sale of RU-486 if it meets FDA standards, said campaign spokesman Douglas Hattaway.

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