The Supreme Court of the United States has overturned a landmark legal doctrine of judicial deference to federal government agencies during litigation in federal courts. The 6-3 decision addresses regulation by the U.S. National Marine Fisheries Service, but implicates all litigation directed against federal agencies, including the FDA.
The Supreme Court handed down its June 28 decision in the cases of Loper Bright Enterprises v. Raimondo and Relentless, Inc., v. Department of Commerce, cases that revolved around the question of whether the fishing industry should be
Under Chevron doctrine, courts were required to apply a two-step test to evaluate the government’s claim, the first of which inquired into whether Congress had provided the agency with unambiguous authority regarding the subject of the dispute. If the government’s position failed to pass this first test, the court would then determine whether the agency’s position was backed by a reasonable interpretation of the statute. A federal agency’s action had to pass only one of these two tests to obtain the court’s deference to the regulatory activity in question.
However, the Supreme Court’s decision in Loper Bright eliminates any need for an evaluation of the government’s position in a case and forces government agencies to argue the merits of their regulatory actions in judicial proceedings. Chief Supreme Court Justice John Roberts wrote in the majority opinion that the Administrative Procedures Act (APA), enacted in 1946, had codified the proposition that the courts are authorized to decide all questions of law arising from a review of agency actions. The APA further affirms that the role of the courts is to determine the boundaries of the authority delegated by Congress to the executive branch.
Roberts stated that the deference required by Chevron doctrine “cannot be squared with the APA,” and that Chevron “demands that courts mechanically afford binding deference to agency interpretations,” including interpretations that have been inconsistently applied over time. He stated that the presumption in Chevron that agencies have a special competence in resolving statutory ambiguities is misguided as this is one of the tasks assigned to the judicial branch.
Associate Justice Elena Kagan wrote the minority dissent, stating that Chevron doctrine has become part of the fabric of modern government. The doctrine has enabled federal government agencies to keep food and drugs safe and financial markets honest, Kagan wrote, stating further that Congress cannot write perfect statutes. She stated also that deference to government agencies is based on implicit congressional delegation of interpretive authority, and that the outcome in Loper Bright suggests that “a rule of judicial humility gives way to a role of judicial hubris.”
The ruling is not retroactive and thus cannot be used to overturn cases that have already been decided, although several cases of interest to life sciences entities may arise. One case that is already in process is the lawsuit against the FDA over the agency’s final rule for lab-developed tests (LDTs).
The American Clinical Laboratory Association filed the lawsuit May 29, 2024, stating that the FDA’s final rule for LDT regulation violates the APA in two ways, including that LDTs are services rather than products subject to FDA oversight. ACLA argued also that FDA regulation of LDTs lacks a clear statement from Congress as to the authority to regulate LDTs and constitutes an inappropriate expansion of agency authority under a long-standing statute. The suit alleges that the FDA had not adequately responded to objections raised by the draft rule, again a requirement of the APA.