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FDA Approves Use of Abortion Pill

The drug will allow more doctors to provide the service and may alter the dynamics of the debate.


WASHINGTON — The Food and Drug Administration gave final approval Thursday to the abortion pill RU-486, offering women the option of terminating early-stage pregnancies with drugs instead of surgery and easing the way for more doctors to provide abortion services.

The drug, approved for use through the first seven weeks of pregnancy, will be marketed as Mifeprex and "the early option pill." Already available in much of Western Europe, it could reach U.S. doctors in about a month.

The pill is part of a two-drug regimen that works by causing a miscarriage and is the first approved alternative to surgical abortions, which in most cases rely on suction equipment to end a pregnancy. The drug has the potential to make abortions more private, moving them from the clinics that are frequent targets of protests and into the offices of thousands of gynecologists and family doctors.

Abortion rights supporters, who worked for 12 years to bring the drug to U.S. consumers, called the FDA decision a milestone in women's health, nearly as significant as the arrival of the birth control pill 40 years ago. Currently, 86% of U.S. counties don't have an abortion provider, but that could change under FDA rules that allow nearly any doctor to offer Mifeprex.

The drug also could encourage women to have earlier abortions, its advocates said. Thanks to increasingly sensitive pregnancy tests available in drugstores, women are finding out earlier than ever that they may be pregnant. Now, many of them will be able to obtain an abortion, without invasive equipment or anesthetic, soon after getting the news.

The FDA announcement immediately became an issue in the presidential campaign, with anti-abortion groups accusing the Clinton administration of trying to marshal its allies in the abortion rights movement. They called attention to the drug's side effects, which include bleeding and cramping, and said that changing the method of abortion does not make the procedure any less immoral.

"We will not tolerate the FDA's decision. . . . We will shout it from the rooftops: RU-486 kills innocent human persons," said Judie Brown of the American Life League, an anti-abortion group. "RU-486 is a chemical assault weapon aimed at the tiniest babies."

President Clinton said the FDA had focused only on patient safety. He declined to portray the decision as a personal victory, though he was instrumental in initiating the FDA review. On his third day in office eight years ago, Clinton ordered federal health officials to find ways to bring the drug to U.S. consumers, in essence reversing the policy of his predecessor, George Bush.

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"The decision to be made under our law is whether the drug should be approved by the FDA on grounds of safety . . . ," the president told reporters Thursday. "I think it ought to be treated as the scientific and medical decision it was, and we should respect the fact that it was a nonpolitical inquiry."

Texas Gov. George W. Bush, the Republican presidential nominee and son of the former president, said the FDA decision is "wrong." But he did not say what he might do as president to try to restrict the drug or remove it from the market.

"I fear that making this abortion pill widespread will make abortions more and more common, rather than more and more rare," Bush said in a statement. "As president, I will work to build a culture that respects life."

Vice President Al Gore, the Democratic presidential nominee, who favors abortion rights, said he was "pleased" by the FDA announcement. "Today's decision is not about politics but the health and safety of American women and a woman's fundamental right to choose," Gore said in a statement.

Mifeprex already has been approved in 18 countries, and more than 500,000 women have used it in Europe alone. In France, the first country to approve the drug more than a decade ago, it accounts for 70% of early-stage abortions and one-third of all abortions. But it has not increased the total number of abortions there, U.S. sponsors of the drug said.

Based on France's experience, U.S. advocates said, the drug will encourage women to have earlier abortions but not more abortions.

The drug's path to approval in the United States had been hampered by opposition from anti-abortion groups. In addition, investors and manufacturers were reluctant to risk lawsuits and abortion protests for a drug with likely revenues of tens of millions of dollars a year, not the billions of dollars that pharmaceutical makers often seek.

In fact, fear of anti-abortion protests prompted unusual measures by the FDA and Danco Laboratories LLC, the small, privately held New York firm that is marketing Mifeprex. The FDA took the uncommon step of declining to release the names of its medical officers who reviewed the drug. A Danco news conference in New York City featured tight security Thursday, which included police guards.

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