FDA’s LDT Final Rule in Jeopardy After Supreme Court Ruling

The future of the Food and Drug Administration’s final rule for laboratory-developed tests (LDTs) is uncertain following a June 28 ruling by the U.S. Supreme Court in Loper Bright Enterprises v. Raimondo.

In a 6-3 decision, the Supreme Court overturned the “Chevron doctrine,” a 40-year-old legal precedent that stated when a federal statute is silent or ambiguous about a particular regulatory issue, courts should defer to the implementing agency’s reasonable interpretation of the law. The Court found that Chevron gave the executive branch interpretive authority that properly belonged with the courts. It also concluded that Chevron deference was inconsistent with the Administrative Procedure Act (APA).

The U.S. health care system is governed by a large and complex web of federal laws that are implemented by agencies like the Food and Drug Administration, Centers for Medicare and Medicaid Services, and Centers for Disease Control and Prevention. Many agency decisions are based on statutory interpretations, so the Court’s ruling in Loper may have significant implications for health policy and the health care system. For example, the decision may result in challenges to an agency’s authority and jurisdiction, as well as its rulemaking processes and actions. It is possible that one of the early test cases of the new framework will be related to the FDA’s LDT final rule, as lawsuits challenging the rule are already underway.

Following the Court’s ruling in Loper, Sen. Bill Cassidy (R- La.) sent a June 30 letter to FDA Commissioner Robert Califf, MD, requesting information on how the agency intends to implement the Supreme Court decision. Cassidy specifically mentioned LDTs as an area where FDA lacks “clear statutory authority” and asked how the agency will apply the Court’s Loper Bright decision to FDA’s actions related to LDT regulation.

AABB will continue to update members of the blood and biotherapies community as new developments arise.