In a 67-page opinion in Alliance for Hippocratic Medicine v. FDA, a federal judge on Friday “stayed” the FDA’s Sept. 28, 2000, approval of the abortion pill and the agency’s follow-up decisions from 2016, 2019, and 2021.
The detailed opinion by Judge Matthew Kacsmaryk, a Trump appointee, addresses an array of complex legal issues. Here’s what you need to know to understand the litigation.
Facts First
In 1996, the Population Council filed an application with the FDA seeking approval of the abortion pill, which is really two pills: mifepristone, also known as RU-486, and misoprostol. Mifepristone blocks the production of progesterone causing the death of the unborn human, who is nurtured by progesterone in utero. Misoprostol then induces “cramping and contractions to expel the unborn human from the mother’s womb.”
The FDA told the Population Council in February of 2000 that it did not believe the evidence submitted adequately demonstrated that the drug, if distributed as proposed, was safe and effective for use. Accordingly, the FDA concluded, the “restrictions on distribution will need to be amended.” Yet a few months later, the FDA approved the abortion drug under its Subpart H “accelerated approval” process.
The FDA’s approval was for use of the drug up to seven-weeks gestation and required three in-person office visits, first to administer mifepristone, second to administer misoprostol, and third to assess any complications and ensure the abortion had been complete. Additionally, prescribers were required to be properly trained and to report any adverse events.
In
