Garrett Coleman '25
Managing Editor
From left to right: Professor Naomi Cahn, Assistant Dean Leah Gould, and Professor Margaret Riley (Photo Credit: University of Virginia School of Law)
On Tuesday, March 28, If/When/How organized a panel to discuss the pending case of Alliance for Hippocratic Medicine v. FDA. The panelists were Professors Naomi R. Cahn and Margaret Foster Riley, as well as Assistant Dean for Public Service Leah Gould. A decision on the case is expected any day now, but this discussion provided information on likely outcomes, the merits of each argument, and the potential implications for abortion and administrative authority more generally.
The case revolves around a medical abortion drug known as mifepristone (“MIFE”),[1] which Professor Cahn called “safer than Tylenol.” It is the first in a series of two drugs that are used in a medical abortion. Professor Cahn also said that these procedures constitute over half of all abortions in the United States. The second drug, misoprostol (“MISO”), is not currently under consideration because it was approved by a different procedure. Professor Riley noted that it can be used for medical abortion by itself, but that this is not the preferred method. Further research is currently being carried out.
The Alliance for Hippocratic Medicine (“AHM”) claims that MIFE was improperly approved under Subpart H of the Federal Food, Drug, and Cosmetic Act (“FDCA”).[2] In the FDA Modernization Act of 1997, Congress clarified that Subpart H was meant to apply to treatments for a “serious or life-threatening condition.”[3] AHM disagrees with this characterization of pregnancy and therefore rejects the FDA’s authority to approve MIFE. While MIFE received Subpart H approval in 2000, its FDA oversight did not end there. MIFE was also subject to a Risk Evaluation and Mitigation Strategy (“REMS”) that was approved by the FDA in 2011.[4]
Professor Riley, with her background in food and drug law, had plenty to say on the validity of AMH’s argument. She claimed that their preliminary brief was filled with “cherry picked” data and that she does not see how it could pass factual review. She also said that the weight of the scientific research was clearly in favor of the safety of MIFE. It is even safer than many approved contraceptives. Further, she tied this case into a larger conservative mission. For example, the Goldwater Institute has wanted to “eviscerate” FDA authority for many decades. In her view, this is part of an attempt to restrict the FDA’s ability to issue a “scientific assessment of the benefits and risks.” She also pointed out that “[t]he weakness for the FDA is that . . . it doesn’t deal with moral issues.” And this opens a lane for states to insert moral considerations into their restrictive legislation, putting it outside of the FDA’s purview.
Her thoughts may not be persuasive to this court in particular, though. Plaintiffs were careful to select the Amarillo division of the Northern District of Texas, in which Judge Matthew Kacsmaryk is the only judge to sit.[5] Judge Kacsmaryk was appointed by President Trump and confirmed by the Senate in 2019. And he is a “devout Christian” who has been described by his sister as someone who is “passionate about the fact that you can’t preach pro-life and do nothing.”[6]
Professor Cahn laid out two options for this court. The first involves deferring to the FDA and its administrative authority. She does not expect this to occur. Rather, she expects Judge Kacsmaryk to conclude that the FDA “overstepped its authority” and that this abortion pill is unsafe. From there, he can send the issue up to the Fifth Circuit, issue a district-wide injunction, or issue a nation-wide injunction.
A complicating factor—and a potential pathway for pro-choice activists—is that there are other recognized medical uses for MIFE and MISO. According to Professor Cahn, the former can be used to treat complications from miscarriages, and the latter is used to treat gastric ulcers. Professor Cahn likened this to how condoms also prevent disease, or how contraceptives are arguably designed to regulate other functions. In the face of increasing scrutiny from those wishing to restrict abortion, these alternative functions will be important.
When the discussion shifted to the potential fallout from this case, Dean Gould raised the concerns of surgical abortion providers. As the primary alternative to the more common medical abortion, she was concerned that there would be a huge influx of surgical abortion patients following restrictions on MIFE. She also said that there will be a “bottleneck . . . at the provider level.” Some of that is attributable to the medical school practice of making abortion an optional training. And some of it can be traced to the generalized fear of doctors that they will be violating the law by providing abortions. Dean Gould also mentioned the implications of bounty laws for abortion services that assist women in more restrictive states. Her view was that these organizations are under low risk when operating outside of the restrictive state’s jurisdiction.
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jxu6ad@virginia.edu
[1] Patricia J. Zettler, et al., Alliance for Hippocratic Medicine v. FDA—Dobb’s Collateral Consequences for Pharmaceutical Regulation, 388 New Eng. J. Med. e29 (2023).
[2] Id.
[3] Id.
[4] Id.
[5] Caroline Kitchener & Ann E. Marimow, The Texas Judge Who Could Take Down the Abortion Pill, Washington Post (Feb. 25, 2023), https://www.washingtonpost.com/politics/2023/02/25/texas-judge-abortion-pill-decision/.
[6] Id.