Time is running out for approval of mifepristone, formerly known as RU-486, a medication used to terminate pregnancies.
Congress will vote in June on an amendment introduced by anti-abortion Rep.Tom Coburn (R-Oklahoma) to prohibit the Food and Drug agency from testing,development or approval of any "abortifacient." Passed by the House in two prior years, President Clinton threatened to veto legislation with theCoburn amendment and the Senate refrained from supporting it.
Moreover, Republican presidential candidate George W. Bush has said that if elected he would likely oppose Food and Drug Administration approval of the treatment. Anti-abortion groups are strongly opposed to mifepristone, calling it "chemical coat hanger" (American Life League); "black death" (World Life League); and "human pesticide" (Focus on the Family).
With mifepristone stuck in the final round of the agency's review, the Feminist Majority Foundation is calling for an "expedited" process to assure that women will have access to the drug.
Mifepristone is part of a two-drug medical regimen that allows women to choose early abortions without a surgical procedure. The agency declared the regimen safe and effective in 1996. Mifepristone also shows great promise asa treatment for shrinking uterine fibroids.
New York-based Danco Laboratories LLC, a pharmaceutical company working in conjunction with the nonprofit Population Council, expectedgovernment approval in early 2000 for manufacture and distribution. Instead,in late February the Food and Drug agency asked Danco to supply more information.
"I don't think the commercial manufacturer will get approval thisyear. There are too many obstacles," said Lawrence Lader, president of theAbortion Rights Mobilization, a New York group that uses mifepristone formedical abortion in 15 clinical trial sites in 11 states and is evaluatingthe drug as a fibroid treatment.
Anti-abortion politics originally blocked U.S. distribution, despite thedrug's use in France since 1988. President Clinton reversed the policy,paving the way for U.S. approval. But a series of frustrating snafus havedelayed release.
The agency's latest questions have been answered, said Danco spokeswomanHeather O'Neill, but neither she nor the agency's Center for Drug Evaluationand Research would elaborate. While confident that mifepristone will bereleased, Danco no longer speculates on a date.
The agency can sometimes move quickly "depending on the clamor and need forthe drug," said Andrea Chamblee, a former agency lawyer, who now consults onregulatory procedures. Typically two concerns are scrutinized at this point:printed information that would accompany the drug and the manufacturingprocess.
A new government method for evaluations of manufacturing may havecomplicated the review, said Chamblee, noting that the agency knows thepolitics surrounding the drug and its reviews probably go to the highestlevels. Post-approval problems are embarrassing and, in this case, "wouldadd wrinkles that the FDA would like to avoid," she said.
"There is a need to mobilize like never before to get it passed before thenext election," said Jennifer Jackman, director of Policy and Research forthe Feminist Majority Foundation. The organization has sponsored a"compassionate care" program of clinical testing that shows mifepristone tobe an effective treatment for meningioma, a brain tumor. It also has starteda postcard campaign to gain approval for the drug.
Pro-choice Rep. Louise Slaughter (D-New York) and other House members sent aletter to the Food and Drug agency, emphasizing the importance ofmifepristone to American women. A copy of the letter has not been released.
In the meantime, the National Abortion Federation is training doctors incorrect treatment procedures for mifepristone. "It has been used as apolitical football, and I'm hoping that we're coming to the end of that,"said Vicky Saporta, executive director of the federation.
Mifepristone, an antiprogestin, can be used within seven weeks of the startof a woman's last menstrual period, and is followed two days later by a doseof misoprostol, a prostaglandin. The drugs cause the body to expel fetaltissue in 95 percent of cases. If the regimen fails, a surgical abortion isperformed. A second drug already on the market for other uses--methotrexate-- is sometimes prescribed by doctors for early medicalabortion, also in combination with misoprostol.
Lader believes mifepristone ultimately may find its widest use as atreatment for fibroids, which affect 35 percent of women and often result inhysterectomies. As a hedge against further delays, Lader's group is ordering5,000 more pills for clinical test sites. "It's absurd how long this hastaken," he said.