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FDA v. Alliance for Hippocratic Medicine

What’s Next for Medical Abortion? 

Published September 20, 2024

An Opinion Written by Abby Miller


Considering the current uncertain state of abortion in the U.S., it comes as no surprise that medical abortion is now under attack. Mifepristone is a drug that, in conjunction with another drug, misoprostol, forms the “abortion pill". Not to be confused with Plan B, mifepristone terminates ongoing pregnancies while Plan B prevents a pregnancy from starting. The FDA approved mifepristone in 2000 for termination of early pregnancy under the brand name Mifeprex. In 2016, the FDA approved three changes to mifepristone’s conditions of use, including increasing the gestational age limit from seven to ten weeks. In 2021, the FDA temporarily lifted the in-person requirement for obtaining mifepristone due to the risk of COVID-19 exposure and, by the end of the year, had repealed the requirement indefinitely (FDA v. Alliance for Hippocratic Medicine, 2023). 

 

The prevalence of mifepristone’s usage cannot be understated: Guttmacher Institute found that 63% of abortions in 2023 were performed using this “pill”, a 10% increase from 2020 (Jones & Karnik, 2024). The existence of mifepristone on the market, its wide usage, and the loosening of requirements for use struck a nerve with anti-abortion activists. In November 2022, a group of doctors and associations of doctors who oppose abortion, entitled the Alliance for Hippocratic Medicine (AHM), sued the FDA for many of its actions regarding mifepristone, including its 2000 approval of Mifeprex and the 2016 and 2021 relaxations to the drug’s conditions of use. The AHM claims it has standing because it represents anti-abortion doctors who may have to engage in emergency abortion procedures due to medical complications from mifepristone use. It sought a preliminary injunction order for the FDA’s actions regarding mifepristone, arguing based on the Administrative Procedure Act (APA) and its prohibition of arbitrary and capricious agency actions. Under the APA’s definition, a decision is arbitrary and capricious if it is ostensibly random and unreasonable. The AHM claims that the FDA’s actions approving and increasing access to mifepristone were, in fact, arbitrary and capricious due to insufficient preliminary drug testing. In response, the FDA argues that not only were their actions non-arbitrary and non-capricious on account of extensive research and testing, but they also argued that the AHM lacks standing to sue the FDA in the first place. The AHM failed to cite a person who had been harmed in their hypothetical scenario (FDA v. Alliance for Hippocratic Medicine 2023). 

 

The U.S. Court of Appeals for the Fifth Circuit’s ruling for FDA v. Alliance for Hippocratic Medicine established the current state of mifepristone access: it held that the AHM did have standing, and it upheld a suspension of the FDA’s 2016 and 2021 changes to mifepristone’s conditions of use. It did not, however, overturn the FDA’s 2000 approval of mifepristone; the drug is still available, albeit with pre-2016 restrictions (Belluck and Jewett 2023). The FDA filed an appeal to the Fifth Circuit’s suspension of its 2016 and 2021 actions, turning the issue over to the Supreme Court. 


If the Supreme Court rules in favor of the FDA, then increased access to abortion pills will be restored: a major win for pro-choice activists. If the Court rules in favor of the AHM, the FDA’s 2016 and 2021 changes are not repealed indefinitely; the FDA can perform more drug testing to support their changes to conditions of use, and if the Court finds the changes to no longer be arbitrary and capricious, they will be reinstated. There is a strong possibility that the FDA would succeed in retesting mifepristone’s safety, so it is alarmist to claim that this case is the end of medical abortion as we know it. Still, the very fact that the AHM’s challenges to the FDA came this far in the Supreme Court may give rise to other legal challenges to the FDA’s medication-approval processes and warp the public’s opinion on the FDA’s credibility. More than 400 drug company executives have signed a statement condemning the Fifth Circuit’s ruling for disempowering the FDA's ability to make scientific judgments and keep the public safe (Belluck and Jewett 2023). With repercussions extending beyond abortion access, FDA v. Alliance for Hippocratic Medicine is a notable case that merits significant consideration from the Supreme Court. 

 

 

 

Belluck, Pam, and Christina Jewett. “Drug Company Leaders Condemn Ruling Invalidating F.D.A.’s Approval of Abortion Pill.” The New York Times, April 10, 2023. 

Golde, Kalvis. “Food and Drug Administration V. Alliance for Hippocratic Medicine.” 

 

 

Jones, Rachel K., and Amy Friedrich-Karnik. “Medication Abortion Accounted for 63% of All US Abortions in 2023-an Increase from 53% in 2020.” Guttmacher Institute, March 19, 2024. https://www.guttmacher.org/2024/03/medication-abortion-accounted-63-all-us-abortions-2023-increase-53-2020. 


 
 
 

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