Activists Brace for FDA's Decision on Abortion Pill
Over the summer, FDA officials backed down on a number of the initially proposed set of restrictions, says Sandra Waldman, a spokeswoman for the Population Council, the nonprofit group and owner of the RU-486 patent. "I wouldn't anticipate anything," Waldman says. "We have had very positive discussions."
And, argues Chavkin, there is little merit to the FDA's safety concerns. The majority of women are unlikely to use an abortion pill more than once in their lifetime and the side effects, while possibly severe, generally are quickly resolved, she tells WebMD. Considering the drug's risk and benefit profile, "American women will not tolerate being deprived of this important option," Chavkin says.
But because of past blunders, pro-choice groups such as the National Abortion Rights Action League (NARAL) are taking no chances. Politics historically has surrounded the process and, as a result, the group is making a concerted effort to ensure that people see the approval as a political issue, Betsy Cavendish, JD, legal director of NARAL, tells WebMD.
"If Bush is elected, it could be the end of the day. We can't take that chance," Cavendish says. "Women deserve to have access to the full range of reproductive options."
Anti-abortion rights groups also are making special preparations for the day-after battle. That fight will take place on a number of fronts, Cirmo assures WebMD. For example, in the early 1990s, anti-abortion rights forces even managed to convince the drug's French developer, Roussel Uclaf, to abandon the drug by boycotting its other products, she points out.
If approved, RU-486 will now be made and marketed by a New York City-based group of investors who have incorporated under the name Danco and have a licensing agreement with the Population Council. Compared with other drugmakers, Danco is a "mom and pop" operation reportedly operating on a limited budget. But despite a possible profit of tens of millions of dollars, the big pharmaceutical makers have all declined to manufacture the drug.
Ironically, this manufacturing arrangement ultimately could be the greatest obstacle to the eventual distribution of RU-486. According to the latest reports, this group of investors intends to manufacture the drug in China, which reportedly has raised concerns among FDA officials about their ability to oversee and inspect that process.