In May 2020, the American College of Obstetricians and Gynecologists (ACOG), along with other organizations and physicians (Council of University Chairs of Obstetrics and Gynecology, New York State Academy of Family Physicians, SisterSong Women of Color Reproductive Justice Collective, Honor MacNaughton, MD), filed a civil action against the US Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) challenging the requirements of in-person mifepristone dispensing, which was one of the 3 restrictions placed on the medicine as part of mifepristone’s risk evaluation and mitigation strategy (REMS). The requirements, which also include provider certification and patient signatures on specified consent forms, specifically target dosages of mifepristone for use related to abortions and miscarriages but do not apply when prescribing mifepristone for other medical conditions, even with higher doses. During the pandemic, the FDA suspended the REMS requirements for many other medications, including those more toxic than mifepristone. Additionally, the HHS activated a “telemedicine exception” that allows physicians to use telemedicine to satisfy mandatory requirements for prescribing controlled substances, including opioids, while minimizing the patient’s and provider’s risk of exposure to COVID-19 with in-person appointments. Notably, mifepristone for abortion and miscarriage management was excluded from this relaxation of the REMS requirement.
On July 13, 2020, a Federal District Court concluded that the in-person requirements were a “substantial obstacle” for women seeking abortions during the COVID-19 pandemic and granted a preliminary injunction to temporarily stop the FDA’s enforcement of the in-person requirements for mifepristone. We wrote about what that decision meant for ObGyns and urged clinicians to advocate to make the injunction permanent (OBG Manag. 2020;32(12):13-14, 23, 38. doi: 10.12788/obgm.0034.)
From there, however, the FDA worked to reverse that decision, which included applications to the District Court and to the Supreme Court for a stay of the injunction. If successful, this would suspend the injunction while the case was pending. In October, after the Supreme Court deferred review of the application (preferring a review by the lower courts), the District Court upheld the injunction of the in-person requirements citing the worsening pandemic crisis.
In-person requirement re-instated
On January 12, 2021, the United States Supreme Court granted the stay of the District Court’s injunction, which allowed the federal government to enforce the in-person requirement for mifepristone once again. The decision came down to a vote of 6 to 3. As is typical for decisions on stay orders, the court did not release a majority opinion explaining the reasoning behind this decision. In a concurring opinion, Chief Justice John Roberts wrote that the decision was not a judgment of if the requirements for in-person dispensing of mifepristone imposed an undue burden on women seeking an abortion. Instead, the Chief Justice explained that the decision came down to if a District Court could order the FDA to change their regulations based on “the court’s own evaluations of the COVID-19 pandemic,” maintaining that the court could not overrule “the politically accountable entities with the ‘background, competence, and expertise to assess public health.’”1 No other justices joined his opinion.