On December 10th, 2020, the Supreme Court of the United States (SCOTUS) issued a controversial ruling that could potentially undermine the Food and Drug Administration’s (FDA) drug-approval authority. The case, FDA v. American College of Obstetricians and Gynecologists, involved the FDA’s restrictions on medication abortions during the COVID-19 pandemic.
Medication abortions, also known as abortion pill, involve taking two pills: mifepristone and misoprostol. The FDA had previously required that mifepristone be dispensed only in a clinic or hospital, but the agency loosened those restrictions during the pandemic to allow patients to receive the drug by mail. However, the FDA’s decision was challenged by the Trump administration, which argued that the drug could be dangerous and should only be dispensed in person.
In a 6-3 ruling, SCOTUS allowed the lower court’s decision to stand, which effectively lifted the FDA’s in-person dispensing requirement for mifepristone. While the ruling specifically addressed the FDA’s COVID-19-related restrictions on medication abortions, it has broader implications for the agency’s drug-approval authority.
Under the Federal Food, Drug, and Cosmetic Act, the FDA has the authority to regulate the safety and effectiveness of drugs, including how they are dispensed. The agency’s regulations are based on scientific evidence and are designed to protect public health. However, the SCOTUS ruling suggests that the agency’s regulations may be subject to legal challenges based on individual circumstances, which could have significant implications for the FDA’s authority.
Critics of the ruling argue that it could open the door for other legal challenges to the FDA’s drug-approval process. For example, drug companies may challenge the FDA’s approval requirements, arguing that they are too strict or unnecessary. Patients may also challenge the FDA’s restrictions on certain drugs, arguing that they are necessary for their individual health needs.
Proponents of the ruling, however, argue that it is a victory for patients’ rights and access to healthcare. They argue that the FDA’s in-person dispensing requirements for medication abortions placed an undue burden on patients, particularly during the COVID-19 pandemic when access to healthcare was limited.
While the ruling specifically addressed the FDA’s restrictions on medication abortions, its broader implications for the agency’s drug-approval authority remain unclear. As the FDA continues to navigate the complex and rapidly changing landscape of drug regulation, it will be important to carefully consider the potential legal challenges and implications of its decisions.