U.S. Overturns Chevron Doctrine

The United States Supreme Court ended the 40-year-old Chevron doctrine which directed federal courts to give deference to administrative agencies’ reasonable interpretations of ambiguous federal statutes. The June 28, 2024 decision will significantly impact federal agencies’ rulemaking and enforcement of federal laws related to a wide variety of administrative laws, including those related to the FDA.

The Supreme Court held that courts must exercise their independent judgment when deciding if an agency acted within its statutory authority and cannot defer to an agency’s interpretation of ambiguous laws.

The Court determined that Chevron conflicts with the Administrative Procedures Act (APA) which requires that courts, and not individual agencies, decide all relevant questions of law and should interpret statutory provisions. Ambiguities in the law are not implicit delegations of authority to agencies the Court stated, because the agencies have no “special competence in resolving statutory ambiguities.” Thus, the courts should not declare a particular party’s reading of a statute as permissible, but should “use every tool at their disposal to determine the best reading of the statute and resolve the ambiguity.”

The Court did state that the decision does not call into question previous decisions that relied on Chevron. A statement the Court hopes will stave off hundreds of potential challenges to such decisions.

The decision has significant implications for the FDA, which given its scientific underpinnings will have to be even more rigorous in making rules related to the industries it regulates.

For our clients, this ruling underscores the importance of staying informed about evolving legal landscapes and seeking expert guidance when navigating regulatory compliance. Our team is well-versed in the intricacies of FDA regulations and litigation. We stand ready to assist you in understanding the implications of this landmark decision for your specific needs. If you have any questions or concerns, please don't hesitate to reach out to us.