The case concerning the abortion pill before the Supreme Court has the potential to significantly impact not just abortion rights but also the entire regulatory framework for pharmaceuticals in the United States.
A group of anti-abortion doctors and organizations has initiated a lawsuit against the Food and Drug Administration (FDA), aiming to restrict access to mifepristone, the initial medication in the two-pill regimen for medication abortions. Since its FDA approval in 2000, over five million women in the U.S. have used mifepristone.
Should the Supreme Court favor the plaintiffs and opt to diminish or nullify FDA regulations regarding mifepristone, it would mark an unprecedented challenge to the FDA’s autonomy in determining the usage conditions for medications. This possibility has alarmed drug policy experts and numerous pharmaceutical firms. They caution that such a verdict could pave the way for legal challenges against other medications, including those that have sparked political controversy like vaccines or emergency contraception. Firms are concerned that doubting the FDA’s regulatory power could influence their decisions on drug development and availability.
More than 300 industry leaders and associations have expressed their concerns, stating, “The potential for litigation and regulatory ambiguity threatens to disrupt the drug approval process, deter drug development and investment, stifle innovation, and endanger patient health.”
The lawsuit, filed in November 2022, sought to revoke the approval of mifepristone. In a preliminary decision, Judge Matthew J. Kacsmaryk of the Northern District of Texas, a Trump appointee and known abortion opponent, ruled to remove the medication from the market. However, the U.S. Court of Appeals for the Fifth Circuit later maintained the original drug approval but reversed FDA modifications made in 2016 and 2021 that had made mifepristone more accessible to patients.
If the Supreme Court upholds the Fifth Circuit’s decision, requiring mifepristone to adhere to pre-2016 regulations, patients would face significant obstacles. They would be unable to obtain prescriptions via telemedicine or receive abortion pills by mail, necessitating in-person pickup from a doctor and three doctor visits during the medication abortion process. Additionally, nurse practitioners, nurse midwives, and physician assistants would lose the ability to prescribe mifepristone, further restricting patient access.
The pharmaceutical industry warns that the Fifth Circuit’s stance could make drug development impractical and lock approved drug use conditions in time, depriving patients of the advancements in science and imposing outdated, unnecessary burdens on healthcare providers.
The Supreme Court’s ruling’s breadth will determine its impact. Some legal analysts suggest the FDA might manage to maintain the 2016 and 2021 regulations while collecting further data to satisfy the court. Moreover, since the ruling would affect the FDA rather than abortion providers directly, some medication abortion services have been stockpiling mifepristone and may continue to prescribe and distribute their supply.
If obtaining mifepristone becomes impossible, many providers might resort to prescribing only misoprostol, the second drug in the medication abortion regimen. While misoprostol is widely available and used for other medical conditions, it is slightly less effective on its own and more likely to cause side effects like nausea, chills, and diarrhea.