News: Analysis & Commentary: HEALTH CARE
AN INSTANT BUSINESS CALLED THE ABORTION PILL
As the FDA moves toward approval, a startup springs to life
Startups are always fraught with difficulties. But when a company's product is as controversial and revolutionary as the first so-called abortion pill, on track to be approved soon by the Food & Drug Administration, the adversities are far from ordinary.
For Advances in Health Technology, the company awarded the U.S. license to distribute the pill, originally called RU-superscript486, the difficulties "are daunting," says founder Forrest S. Greenslade. Besides scrambling to raise several million in venture capital, company officials have had to contend with fears of violence from abortion foes and with the politics of seeking FDA approval for the drug in an election year. "This company has a lightning rod around it," says Greenslade, who is also the president of IPAS, a group that works to assure safe abortions in developing countries.
Now, despite the hurdles, that work may be paying off. The FDA will hold hearings on the pill, now called mifepristone, on July 19. Capitol Hill insiders predict that if current FDA staffers remain in place after the election, approval could come by yearend.
If successful, mifepristone's path to commercial use could be a model for other companies seeking to develop new reproductive technologies. Such research has virtually ground to a halt in the U.S. in recent years because of liability concerns and the political controversy created by abortion foes. There are only two major drug companies in the field today, compared with nine in the 1970s.
RU-superscript486 has been a particular target of abortion opponents ever since its approval in France in 1988. Its maker, Roussel Uclaf, at first declined to market it in the U.S. out of fear that abortion foes would boycott other products of its parent, Germany's Hoechst. Finally, in 1993, Roussel bowed to pressure from the Clinton Administration to make RU-superscript486 available in the U.S. and ceded the rights to the nonprofit Population Council, an international reproductive-health research organization.
Once that deal was completed, RU-superscript486 all but disappeared from the limelight. Then, in late March, the council announced that it had completed clinical trials, submitted an application to the FDA, and licensed mifepristone to one Advances in Health Technology.
TRAINING TEXTS. Amid the political pressure surrounding abortion, the council remains almost obsessively quiet about its work on mifepristone. The group will say only that Washington-based Advances will be involved in providing educational materials and training for clinics and doctors who may prescribe the abortion pill. The president of the company--Dr. Susan S. Allen, a 36-year-old physician who worked previously for the U.S. Agency for International Development in a contraceptive- research program and for Planned Parenthood of the Rocky Mountains--is equally cagey, fearing possible attacks by abortion foes. "I've been in the world of abortion for a while now," she says. "Harassment comes with the territory."
Incorporation papers provide some answers, though, and show that Advances in Health Technology was incorporated on July 12, 1995. Greenslade, who worked at the Population Council until 1991 and helped commercialize the copper-T IUD in 1989, is the incorporating officer. Advances has both nonprofit and for-profit segments. The nonprofit arm will draw up educational materials, and the for-profit part will manufacture and distribute the drug, Greenslade says.
The price has not been announced yet, but industry experts estimate that the treatment will cost about $50. In all, some 650,000 women annually could use the drug, creating a $32 million market.
A course of treatment has two stages. First, a woman is given three tablets orally. Two days later, she returns for a dose of another drug, prostaglandin. Some 60% of women expel what Allen calls the "pregnancy tissue" within four hours of taking the prostaglandin. Incomplete expulsions, which occur in 4% or fewer cases, require surgery.
The procedure is unpleasant at best. But for many women, mifepristone may be their best hope for a quiet, safe abortion. If, that is, this startup can successfully bring its first product to market.By Naomi Freundlich in New York