On Dec. 23, the U.S. Food and Drug Administration submitted its closing argument in defense of its regulation of laboratory-developed tests (LDTs) as medical devices.
The plaintiffs, the American Clinical Laboratory Association and Association for Molecular Pathology, filed separate lawsuits shortly after the FDA published its final rule regarding LDTs in April. The lawsuits were then consolidated per FDA request in the U.S. District Court in the Eastern District of Texas on Sept. 9. Both organizations seek to challenge the statutory validity of the FDA final rule and ultimately achieve vacatur of the final rule.
In its closing brief, the FDA reasserts its “unambiguous statutory authority” to regulate test systems as “diagnostic ‘apparatuses’ or ‘contrivances’ made up of physical components that work together to produce a test result,” designating these systems as “devices” according to the congressional definition of the term. The FDA attests that the final rule is simply a clarification of existing FDA statutory authority to regulate these systems and a statement of how the FDA will enforce this authority over LDTs.
The FDA denies the implication of the major questions doctrine in this case, claiming the issue lacks the necessary political and economic significance required for the doctrine’s invocation. Additionally, the rule of lenity does not apply because, according to the FDA, there is no ambiguity in this case to resolve.
The FDA also asserts that the statutory authority to regulate in vitro diagnostic test systems, including LDTs, is firmly vested within the Food, Drug, and Cosmetics Act to regulate a test’s clinical validity. The final rule, the FDA argues, is neither duplicative of nor in conflict with the Clinical Laboratory Improvement Amendments of 1988, a more specific statute imbuing the Centers for Medicare and Medicaid Services with the authority to regulate a test’s analytical validity.
Finally, the FDA maintains that the final rule is neither arbitrary nor capricious and contains “thoughtful and reasonable enforcement discretion policies.” The FDA reasserts its position that universal vacatur of the final rule is not an available solution to the plaintiffs’ grievances under the Administrative Procedure Act. Although a Fifth Circuit precedent does allow for universal vacatur, it is not the sole available solution; according to the FDA, the precedent “embraces a more flexible approach that permits the Court to tailor an appropriate remedy consistent with its equitable powers.”
A final decision in this case is not expected until the summer of 2025.
Sources:
https://www.amp.org/AMP/assets/File/advocacy/DOJ_ClosingBrief_12_23_2024.pdf?pass=71
https://www.cap.org/advocacy/latest-news-and-practice-data/september-17-2024#story1
