On June 30, Sen. Bill Cassidy, M.D. (R-La.) sent a letter to U.S. Food and Drug Administration Commissioner Robert Califf, M.D., regarding the applicability of the Supreme Court Loper Bright decision to the agency’s final rule for laboratory-developed tests (LDTs).

The letter comes after the U.S. Supreme Court’s June 28 6-2 decision in Loper Bright Enterprises v. Raimondo, which overturned the Chevron doctrine, a legal precedent that allowed the courts to defer to an executive agency’s “permissible” interpretation of its authorities granted by a federal statute. The court held that “the Administrative Procedure Act requires courts to exercise their independent judgment” rather than defer to the executive branch for interpretation simply because a statute is ambiguous.

Cassidy, ranking member of the Senate Health, Education, Labor, and Pensions Committee, called the decision “an opportunity for executive agencies to reexamine their role relative to Congress.” He expressed his concern that the agency would respond appropriately to the decision, citing the final rule as a moment when the FDA “unilaterally asserted jurisdiction” over LDTs without Congressional authorization. He goes on to state that the legislative history of both the Food, Drug, and Cosmetic Act and the Clinical Laboratory Improvement Amendments of 1988 make it clear that Congress has not given the FDA clear authority over LDTs.

The letter concludes with a list of several questions posed “to understand how FDA will abide by and implement the Court’s new framework,” with a response deadline of July 19.




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