The U.S. Supreme Court on Friday overturned the long-standing Chevron doctrine, which required courts to defer to federal agencies and their interpretation of statutes, putting potential limits on the FDA’s regulatory decisions.
The U.S. Supreme Court on Friday in a 6-3 vote overturned the decades-old Chevron deference doctrine, which could have far-reaching implications for the FDA and its regulatory functions.
The Chevron deference, dating back to 1984, requires courts to defer to federal agencies and their interpretation of statutes as long as the court agrees that the said statutes were ambiguous. The doctrine gave federal agencies strong protection from legal challenges to its actions and discouraged companies from filing complaints.
In the opinion for the majority, Chief Justice John Roberts argued that the Chevron doctrine goes directly against the text of the Administrative Procedure Act, which holds that courts should be the arbiters of all relevant questions of law—not federal agencies.
Chevron “demands that courts mechanically afford binding deference to agency interpretations, including those that have been inconsistent over time,” Roberts wrote, adding that ambiguities in the law does not signal the Congress’ intent “that an agency, as opposed to a court, resolve the resulting interpretive question.”
In overruling Chevron on Friday, the Supreme Court ushered in a new framework, dubbed Loper Bright. Courts are now required to “exercise their independent judgement in deciding whether an agency has acted within its statutory authority” and “may not defer to an agency interpretation of the law simply because a statute is ambiguous.”
This new framework could have significant consequences for the FDA and its regulatory authority, according to an analysis by global law firm Sidley.
The firm contends that Loper Bright could potentially open the regulator’s drug approvals to legal challenges. Companies need to provide “substantial evidence” that their drug candidates are safe and effective before securing approval, but courts in the past have found this ambiguous and have allowed the FDA to ask for additional requirements, such as data showing that the candidate’s effects are clinically meaningful, according to Sidley.
Under Loper Bright, more companies could try and challenge this approach, Sidley warned.
The overturning of Chevron could also pose some jurisdictional questions for the FDA, which is typically given the leeway to decide what constitutes a dietary supplement or a device product. These kinds of determinations affect how products are regulated, produced, or imported—and companies can now mount stronger challenges to this function by the FDA.
In her dissent opinion, Justice Elena Kagan noted that courts do not have the technical expertise to settle certain ambiguities.
“Some interpretive issues arising in the regulatory context involve scientific or technical subject matter. Agencies have expertise in those areas; courts do not,” she wrote. “Some demand a detailed understanding of complex and interdependent regulatory programs. Agencies know those programs inside-out; again, courts do not.”
