Abortion Pill Could Be in the Hands of the Voters

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.

Although the next president could not likely alter an FDA decision with an executive order, specialists in this area of law say he could enforce his will through his choice of FDA commissioner and secretary of the Department of Health and Human Services.

Those officials could revisit the question of the safety of RU-486. Supporters say that no major safety problems arose in U.S. trials or among the 500,000 European women who have used the drug. In the United States, it would be approved for use in the first 49 days of pregnancy, providing an alternative to traditional surgical abortions.

But the drug has side effects. Known formally as mifepristone, RU-486 blocks the action of a natural hormone in the uterus, making it impossible for an embryo to implant itself and grow. In the United States, it would be used in conjunction with a second drug, sold as Cytotec, which causes contractions of the uterus to help expel the embryo.

Side effects include bleeding, cramping, nausea and diarrhea. Although the FDA under one commissioner may have attached little significance to those side effects, alarm bells could ring for another commissioner, providing grounds for reversing previous decisions about the drug.

The next FDA commissioner, who serves at the will of the president, “could make a bunch of findings about safety problems that would support an order withdrawing it,” said Pierce, the administrative law specialist. And if challenged in court, Pierce said, the FDA could point to a 1984 Supreme Court ruling that gives federal agencies wide latitude to act in the absence of precise instructions from Congress. “The general attitude of the court would be reluctance to overturn the agency,” Pierce said.

Indeed, critics of RU-486 have signaled that they may pursue just such a strategy. Lately, they have been focusing not just on RU-486 but on Cytotec. That drug is already approved in the United States for the prevention of ulcers, which leaves doctors free to prescribe it for other uses as well. But the manufacturer has not endorsed its use in abortion and, in fact, has warned about severe side effects in pregnant women.

Citing those reports, Rep. Tom Coburn (R-Okla.), a physician, recently wrote to the FDA asking that, if it approves RU-486, “will you take steps to warn pregnant mothers that their uteruses may explode and they may die if they use Cytotec for inducing abortion and labor?”

“These are powerful, death-dealing chemicals,” said Rep. Christopher H. Smith (R-N.J.). “You put powerful chemicals that destroy a baby into a woman’s system and you’re running the risk of injuring the woman.”

Short of fighting to block the drug from the market, the next administration could also try to tighten the rules under which it is distributed. Those rules are already a point of contention. In June, the FDA signaled that it might require a doctor who prescribes the drug, among other things, to be trained in surgical abortions.

Abortion rights groups said that the restrictions would keep the drug from many women, especially those far from hospitals. Some of those groups say that their lobbying has helped persuade the FDA to loosen those requirements. Abortion opponents say that the rules are medically prudent and, in fact, should be tightened.

The Population Council says that RU-486 is safe, has a long record of success overseas and has not caused a single death when used with Cytotec.

“This represents a real medical breakthrough for women,” said Vicki Saporta, executive director of the National Abortion Federation, which will distribute information on the pill. “It gives them a safe, early option.” Gloria Feldt, president of the Planned Parenthood Federation of America, said that approval of the drug would be “comparable to the arrival of the birth control pill 40 years ago.”