Could SCOTUS Chevron Reversal Reverse FDA's Final Rule on LDTs?

Healthcare policy attorney Michael Werner was quoted in a Medtech Insight, Citeline Commercial article about the potential impact of the U.S. Supreme Court's reversal of the Chevron doctrine on the U.S. Food and Drug Administration's (FDA) final rule regulating laboratory developed tests (LDTs) as medical devices. The article discusses whether the decision, which limits agencies' regulatory discretion when statutory language is ambiguous, could prevent the FDA's final rule from taking effect. Mr. Werner expressed skepticism that a court would step in and tell the FDA its interpretation of a device under the Federal Food, Drug and Cosmetic (FD&C) Act was incorrect or went too far, though he did not rule out other challenges to the regulation.

"I don't think there's much to argue that there was ambiguity, and the FDA abused some kind of interpretation to make this decision. I think this falls within the definition of a medical device," he said.

READ: Could SCOTUS Chevron Reversal Reverse FDA's Final Rule on LDTs?

Holland & Knight announced the formation of its Chevron Deference Working Team in advance of the U.S. Supreme Court's June 28, 2024, Loper decision, which overturned the Chevron deference doctrine and will lead to a period of regulatory changes and potential legal challenges for some time.