Alliance for Hippocratic Medicine v. FDA

In 2000, the Food and Drug Administration (FDA) approved mifepristone—a drug that can be used to terminate a pregnancy—for domestic sale and marketing, subject to certain special restrictions, following an extensive, years-long examination of the drug’s safety and effectiveness. In 2016, following a similarly in-depth analysis of the scientific evidence, the FDA lifted some of the special restrictions it had imposed in 2000. A group of anti-abortion medical organizations filed a 2019 citizen petition with the FDA, challenging the 2016 changes that made mifepristone more easily available to patients who needed it. After the FDA issued a detailed, 40-page letter denying the citizen petition, the organizations filed a lawsuit in federal court in Texas, challenging mifepristone’s 2000 approval, the FDA’s 2016 changes to mifepristone’s special restrictions, and the FDA’s denial of the citizen petition, among other things. The district court held that the plaintiffs were likely to prevail in showing that that the FDA’s actions were arbitrary and capricious and so invalidated all the challenged agency actions. The Supreme Court stayed the district court’s ruling while the government appeals.

Public Citizen filed an amicus brief on appeal in support of reversing the district court’s ruling. The brief explains that the FDA approves a new drug or modifies restrictions on an existing drug’s use only after a team of doctors, chemists, microbiologists, statisticians, pharmacologists, and other experts has conducted an in-depth analysis of a vast body of technical evidence of the drug’s safety and efficacy, including peer-reviewed scientific literature and the results of clinical trials conducted with oversight from disinterested institutional review boards. Given the rigor and reliability of this process, the FDA’s decision to deny a citizen petition that—like the one in this case—neither identifies a meaningful procedural flaw in the FDA’s process nor relies on new evidence showing lack of safety or effectiveness should rarely be overturned. Because the 2019 citizen petition did neither of these things, the FDA’s denial of the petition—the central agency action that occurred within the six-year statute of limitations that applies to the plaintiffs’ claims—was not arbitrary or capricious.

The court of appeals reversed the district court in part and affirmed in part: It held that the challenge to the 2000 approval was barred by the statute of limitations and that the plaintiffs lacked standing to challenge the 2019 approval of a generic version of the drug. However, it agreed with the district court order enjoining the FDA’s 2016 changes, which made access to the drug easier. At the same time, it recognized that the injunction has been stayed by the U.S. Supreme Court, so the 2016 changes remain in effect as the litigation continues.