On August 13th the Food and Drug Administration (FDA) approved the drug “ella” (ulipristal acetate) for prescription use as emergency contraception (EC). The agency recommended it for “occasional” use up to five days following either unprotected intercourse or contraceptive failure, causing the Drudge Report to name it the “week-after pill.” The innocently named ella has the potential to do far more than merely prevent ovulation or even prevent embryonic implantation: there is good reason to believe it can also act as an “abortion drug” in the vein of RU-486, interfering with and indeed ending implanted pregnancies. As such, the approval of ella rightly ought to have involved more than antiseptic scientific data, institutional reviews, and clinical trials: ella’s approval and use raises fundamental questions of life, death, and ethics that our regulatory system is ill-equipped to answer.
Given the probable usefulness of ella as an abortion pill, the FDA’s approval of the drug for EC prescription is only the beginning of the controversy surrounding ulipristal. A newly approved abortion drug for EC purposes will warrant future regulatory battles over the drug’s labeling, disputes over abortion funding, and, ultimately, demonstrate the inadequacy of our current pharmaceutical regulatory regime in controlling the “off-label” use of drugs. (“Off-label” use of drugs, of course, refers to the use of drugs for purposes outside of their FDA marketing approval. The possibilities for the “off-label” use of ella are obvious.) Read more