The US Supreme Court is currently presiding over the case, U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine. The case, which challenges the FDA’s decisions to expand access to mifepristone—a drug generally used for abortions, is predicted to have profound implications both for reproductive health and the accessibility of safe and effective medicines in America. Decisively, it might impact the overall functionality of the administrative state.
In the year 2000, the FDA approved Mifeprex (mifepristone’s brand name) to be used in conjunction with another drug, misoprostol, to induce abortions. The approval was subject to certain conditions and prescriptions were limited to pregnancies of less than seven weeks. After closely examining abundant evidence of the drug’s efficacy and safety, the FDA decided to ease these constraints in 2016.
Last year, the Alliance for Hippocratic Medicine sued the FDA, challenging the approval of mifepristone and the subsequent relaxation of restrictions. In April, Judge Matthew Kacsmaryk stayed the FDA’s approval of the drug, finding that the Alliance had standing to sue, citing the FDA’s actions may have violated the Administrative Procedure Act and Comstock Act.
Following an appeal, a US Court of Appeals for the Fifth Circuit panel found that the FDA had insufficiently reviewed the drug’s safety and ordered that the original restrictions be reinstated. The Supreme Court later stayed that order pending their review of the case.
A decision backing the Fifth Circuit’s ruling could critically impact the access to reproductive health services. Since the approval, millions of women have used mifepristone for abortions, with recent data from the Guttmacher Institute revealing that 53% of all facility-based abortions use mifepristone—a 137% increase from 2012 to 2021.
Effectively, telehealth access has been of paramount importance to patients living far from abortion services, including those in states where abortion is illegal. Using data collected by the CDC, legal abortion via telehealth facilitates easier and less expensive treatments for early termination of pregnancies, given these account for nearly 93.5% of all abortions in the US.
Furthermore, the suit could potentially destabilize the pharmaceutical market. The standing position established by the Fifth Circuit could create the foundation for almost any healthcare provider challenging any action taken by the FDA. This ruling might thus discourage the approval of controversial drugs and hamper pharmaceutical advancements.
The decision is awaited by June 2023. You can follow the case at All. for Hippocratic Med. v. United States Food & Drug Admin.