In the Press
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Thursday, April 6, 2023
Panel Examines Medication Abortion Access
Left to right: Panel moderator Beatrice Brown ’25 and panelists Ameet Sarpatwari, Patricia Zettler, and Lewis Grossman.
The Solomon Center for Health Law and Policy hosted a panel discussion titled, “The Future of Medication Abortion: Regulation and Ongoing Litigation,” on April 4.
The panel was moderated by Beatrice Brown ’25 along with panelists Lewis Grossman, Professor of Law and Affiliate Professor of History, American University Washington College of Law; Ameet Sarpatwari, Assistant Professor of Medicine, Harvard Medical School; Associate Epidemiologist and Assistant Director, Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital; and Patricia Zettler, Associate Professor, The Ohio State University Moritz College of Law.
The discussion began by reviewing how the U.S. Food and Drug Administration (FDA) reviews and approves certain medications, such as mifepristone and misoprostol, two medications used to terminate early pregnancy.
The FDA evaluates a certain drug and determines it higher risk of safety concerns than the norm, it can leverage its authority (which has been granted by Congress) to require that medication to use Risk Evaluation and Mitigation Strategies (REMS). Only a few medications require REMS monitoring, but even those that do have ultimately been determined to carry a higher benefit than harm, so the rules further state that regulation or administration of these REMS medications may not further impose “undue burden” on patient access and/or the health care system.
States that have chosen to impose additional restrictions on these medications run into issues with the preemption doctrine, according to the panelists. The preemption doctrine places greater emphasis on upholding laws that stem from the higher authority in a given situation. In this instance, since the FDA has issued rules on what restrictions may be placed on REMS medication usage, a lower authority may not impose rules that conflict with or supersede the FDA’s higher authority. Earlier this year, cases were brought in North Carolina and West Virginia challenging those states’ restrictions on mifepristone access.
Panelists discussed potential outcomes stemming from these cases. One common hypothesis they raised was that the FDA may “slow walk” removal of the drug, or simply ignore a court’s ruling because it understands its authority stemming from Congress is higher than a state authority or a court ruling on this issue. Discussion also included the balancing act of recognizing a state’s interest in protecting the public from harmful drugs while ensuring access to medication treatment, as well as political motivations behind restricting access to certain drugs.
The North Carolina and West Virginia cases have the potential to undermine the authority of a federal agency already facing criticism based on misinformation and political malfeasance, panelists said. The ongoing litigation in these cases also raises issues surrounding how states and various stakeholders think about impacting access to treatments that have been established components of the U.S. health care system.
READ MORE FROM THE PANELISTS:
- Brief for Food and Drug Law Scholars as Amicus Curiae, U.S. Food & Drug Administration, et al. v. Alliance for Hippocratic Medicine, et al. (2023).
- Mifepristone, Preemption, and Public Health Federalism, Journal of Law and the Biosciences (Dec. 21, 2022).