Supreme Court ‘Chevron’ Ruling and Potential Impacts to the New FDA LDT Ruling
On Friday, June 28th, 2024, the Supreme Court, in a 6-3 vote, overruled the 1984 decision in Chevron v. Natural Resources Defense Council. The “Chevron” ruling had required federal courts to defer to the reasonable interpretations of statutes by the agencies responsible for their enforcement. However, the new ruling states, “The Administrative Procedure Act requires courts to exercise their independent judgment in deciding whether an agency has acted within its statutory authority, and courts may not defer to an agency interpretation of the law simply because a statute is ambiguous.”
This decision could have significant implications for various regulatory agencies, including the Food and Drug Administration (FDA). The critical question in the American Clinical Laboratory Association (ACLA) lawsuit against the FDA revolves around whether the FDA has the authority to regulate Laboratory Developed Tests (LDTs). The Supreme Court’s overruling of the Chevron decision may make it more challenging for the FDA to defend its regulatory actions, as courts will no longer automatically defer to the agency’s interpretation of its statutory authority.
As more information and opinions on the impact of this ruling are released, we will continue to provide updates.