Activists Brace for FDA's Decision on Abortion Pill
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.
In the end, whether the drug is distributed and used in the U.S. also may depend more upon what voters do during the November elections rather than what the FDA does this week, Cavendish reiterates. Even if RU-486 is approved prior to the elections, pro-choice Americans will still need to take the fight to the voting booth if they want to ensure that the drug is made and distributed, Cavendish insists.
"They [anti-abortion groups] are relentless, and now, we need to be relentless," she tells WebMD.