FDA Expected to Approve Abortion Pill
WASHINGTON — The Food and Drug Administration is poised to give final approval as early as today to RU-486, the “French abortion pill†that is widely available in Europe but has been stalled in the United States by abortion politics and business hurdles, supporters of abortion rights say.
The FDA action, if it comes as expected, would provide American women with the first approved alternative to so-called surgical abortions, which are usually provided by suction equipment. The drug has long drawn protests from abortion rights opponents, who vowed this week to try to stop the FDA in Congress or by appealing to the next president.
The pill is actually part of a two-drug regimen that, under the protocol considered at the FDA, would require women to make three trips to a doctor’s office over a two-week period. The FDA is considering the drug for use through the first seven weeks of pregnancy. But once it is approved, doctors could offer it “off label†as they wish, and some doctors say clinical trials already show it to be effective through the first nine weeks of pregnancy.
The drug has been available in France and China for 12 years, and more than 1 million women have used it in Europe alone.
The FDA has been reviewing the drug since 1994. It has long said it would take its next step in the approval process by Saturday. But among abortion rights advocates, that next step is expected to be a final approval.
Moreover, several people who have been following events closely say the FDA is likely to approve the drug without many of the restrictions that the agency had suggested earlier this year in private discussions with Danco Laboratories LLC, the small New York company that won the right to market the drug in the United States after larger pharmaceutical firms turned it down.
Under those rules, doctors offering the drug would have had to be trained in surgical abortions and hold admitting privileges at a nearby hospital. Supporters of those rules said they were necessary to ensure adequate care for the few women who suffer excessive bleeding, and for the 5% to 8% for whom the drug is not effective.
But critics said the rules would have sharply and unnecessarily curtailed access to the drug, especially in rural areas, where abortion providers are scarce.
“We fought back really hard,†said Betsy Cavendish, legal counsel to the National Abortion and Reproductive Rights Action League. “Danco really tried to get information to the FDA that suggested these rules were unnecessary for women’s safety and health.†Abortion rights advocates warned, however, that the FDA decision on the drug was not final and could change.
“I think this is a frightening turn in history, a basic corruption of the function of the FDA to safeguard public health,†said Randall K. O’Bannon of the National Right to Life Committee, anticipating FDA approval. “This agency is supposed to be dedicated to healing, and now it’s approved a drug whose purpose is to take the life of a human being.â€
