WASHINGTON - The controversial French "abortion pill" moved a giant step closer to final approval yesterday.
The Food and Drug Administration officially declared that mifepristone - also known as RU-486 - is safe and effective, and said it can approve the drug once its sponsor, the New York-based Population Council, provides additional information on such issues as manufacturing practices and labeling.
To induce abortion, the drug would be taken in combination with misoprostol, which has already been approved by the agency for other purposes.
The FDA action paves the way for the first approval of a "medical abortion," or a method for terminating pregnancy that does not require surgery.
The treatment promises to expand access to abortion in the United States, because it could be offered outside the usual setting of abortion clinics, and doctors could prescribe it without drawing the attention of anti-abortion activists to their practices.
It comes at a particularly tense time in the debate over abortion. Congress is preparing to vote today on overturning President Clinton's veto of a bill banning a late-term procedure that opponents call "partial-birth" abortions.
"We're absolutely delighted with the news," said Susan Allen, president of Advances in Health Technology, the non-profit organization that has lined up a manufacturer and a distributor for mifepristone once it gains final approval. AHT has declined to name either company. Allen said she will disclose the name of the distributor at a later date.
The name of the manufacturer is being kept secret because it could become a target for a boycott or other actions by anti-abortion groups. Federal law does not require the manufacturer to be publicly identified, although the FDA will have to inspect and approve its manufacturing plant and processes.
Anti-abortion groups condemned the FDA move. "We consider this a tragedy for unborn children, whose tiny beating hearts will stop - and for their mothers, since we don't know what the long-term side effects will be," said Michele Arocha Allen, communications director for National Right to Life.
Gracie Hsu of the Family Research Council called the news "very sad," and said the agency had "put politics before women's health."
In determining that the medical abortion procedure is safe, the FDA followed the advice of one of its advisory panels, which in July voted 6 to 0 with two abstentions in support of a statement that the benefits of the two-drug regimen outweighed the risks. That panel reviewed two French trials of the drug involving 2,480 women and an additional trial involving more than 2,000 women conducted in the United States by the Population Council.
The clinical trials showed that the two-drug treatment was 95 percent effective in terminating pregnancy. Its side effects included painful uterine contractions, nausea, vomiting, diarrhea and headache. A small number of women in the trials had to be hospitalized or given transfusions because of bleeding, and 1.5 percent of participants in the U.S. trial required a subsequent surgical abortion.
Under the proposed regimen, women taking the drugs would have to see a doctor three times. Some critics contended that poor and uninsured women might not receive adequate monitoring during the treatment.
During the advisory-panel meeting, Cassandra Henderson of New York's Albert Einstein College of Medicine contended that the panel had not been presented with adequate evidence that women outside the controlled environment of a clinical trial would follow through on all three visits. Those women might develop medical complications, or might not abort and could then deliver children harmed by the drug, Henderson said, creating "a great risk for harming a very large, vulnerable population of patients."