The Supreme Court on Friday overruled a longstanding legal doctrine that gives federal agencies latitude to interpret federal law, which legal scholars and industry have warned could destabilize the FDA.
In the 6-3 opinion, the court overturned the 40-year-old legal doctrine, known as the Chevron doctrine, which agencies have used to make regulatory decisions without having to consult Congress or the courts. Writing for the majority, Chief Justice John Roberts argued that Chevron went too far in interpreting the Administrative Procedure Act as giving agencies permission to interpret ambiguous federal statutes.
“A statutory ambiguity does not necessarily reflect a congressional intent that an agency, as opposed to a court, resolve the resulting interpretive question,” Roberts wrote. “Many or perhaps most statutory ambiguities may be unintentional. And when courts confront statutory ambiguities in cases that do not involve agency interpretations or delegations of authority, they are not somehow relieved of their obligation to independently interpret the statutes.”
But writing for the minority in opposition, Justice Elena Kagan fiercely disagreed. She explained how it’s not appropriate for courts to make complex scientific decisions for which the agencies have the specialized knowledge and personnel. She pointed to a provision in the Public Health Service Act that gives the FDA the authority to regulate biological products, including proteins.
“When does an alpha amino acid polymer qualify as a ‘protein’?” Kagan wrote. “I don’t know many judges who would feel confident resolving that issue. (First question: What even is an alpha amino acid polymer?) But the FDA likely has scores of scientists on staff who can think intelligently about it, maybe collaborate with each other on its finer points, and arrive at a sensible answer.”
Reshma Ramachandran, a professor of medicine at Yale University and the chair of Doctors for America’s FDA taskforce, wrote in a post on X (formerly known as Twitter) that she’s concerned the court’s decision could lead to potential delays in the FDA’s issuing of regulations as it could take longer to determine what authority the agency holds.
She also said that lower courts could come to different conclusions about the FDA’s authority, which would be further destabilizing for the agency.
“By having courts seize the reins in being the ultimate arbiters of administrative authority, the Supreme Court has only further politicized regulatory processes that should be grounded in science and expertise,” she said in a statement.
Rachel Sachs, a professor of law at Washington University in St. Louis, told Endpoints News that the majority opinion focuses on its high-level interpretation of the APA, but it doesn’t get into the details of how removing the Chevron doctrine will affect agencies.
“It overrules Chevron, but it says very little about what should replace it,” she said.
Holly Fernandez Lynch, a professor of medical ethics and health policy at the University of Pennsylvania, said in an interview with Endpoints that the federal statute for approving new drugs is left incredibly vague. Without Chevron, it could be left up to interpretation by the courts.
She added that Congress sometimes leaves laws ambiguous on purpose because it’s impossible to tell how an agency will need to respond in the future.
“Think about the changes in AI technology over the past couple of years,” she said. “There’s law that is applicable to AI that was passed before AI was even a glimmer in anyone’s eye.”
The FDA declined to comment, deferring to the Department of Justice. The DOJ did not immediately return Endpoints’ request for comment.