In 1937, a pharmaceutical company known as S.E. Massengill Co. introduced a new liquid formulation of the drug sulfanilamide, intended to alleviate sore throats with a raspberry-flavored taste. Unfortunately, the formulation contained diethylene glycol, a poisonous substance that led to the deaths of over 100 individuals, including many children, who consumed it. This tragedy prompted Congress to pass the Federal Food, Drug, and Cosmetic Act in 1938, granting the FDA the authority to require drug safety evaluations before market approval. Subsequent amendments in 1962 mandated proof of drug effectiveness as well.
Now, more than six decades later, a case concerning the medication abortion drug mifepristone, argued before the US Supreme Court, threatens to disrupt this established drug approval process. The case has garnered attention from medical professionals, former FDA commissioners, legal scholars, and pharmaceutical industry stakeholders, all concerned about potential ramifications.
At the heart of the case lies mifepristone, a key component in medication abortion regimens that accounted for the majority of abortions in the US in 2023. Plaintiffs, including anti-abortion doctors, have challenged the FDA’s approval of mifepristone since 2000, arguing that it was inappropriate and expanded usage after 2016 was unwarranted.
If the Supreme Court rules in favor of the appeals court, mifepristone’s approval could revert to pre-2016 conditions, potentially restricting telehealth access to medication abortion and imposing other limitations. However, the broader implications of the case extend beyond abortion rights.
Experts warn that weakening the FDA’s authority could enable challenges to drug approvals based on ideological grounds, hindering public health efforts. Furthermore, a less stable regulatory environment may deter investment in drug development, impeding innovation and limiting treatment options for patients.
While the immediate impact of the case could affect mifepristone’s availability, the long-term consequences may reshape the drug approval landscape and impact pharmaceutical industry practices. The outcome of the case remains uncertain, with potential implications reaching far beyond reproductive health.
