The U.S. Food and Drug Administration defended its regulation of laboratory-developed tests (LDTs) as medical devices in a legal brief filed on Oct. 25.
Both the American Clinical Laboratory Association and the Association for Molecular Pathology have filed lawsuits against the FDA final rule in U.S. District Courts, challenging its regulation of LDTs “as exceeding FDA’s statutory authority and as arbitrary and capricious in violation of the Administrative Procedure Act (APA).” In the recently filed brief, the FDA denies any merit to these challenges for the following reasons:
- According to the FDA, it is incorrect to argue that LDTs are intangible services, rather than physical devices, and thus, they are not subject to the FDA device authorities. The object of regulation, while produced in a lab and monetized on a fee-for-service basis, “is comprised of physical components that function together to produce a test result based on a physical specimen taken from the human body.”
- The Clinical Laboratory Improvement Amendments of 1988 (CLIA) did not displace FDA jurisdiction to regulate LDTs, but instead complements its authority vested in the Food, Drug and Cosmetics Act (FDCA), the FDA states in the brief. The agency argues, “regulation under CLIA addresses the proficiency with which laboratories perform tests rather than design them [while] regulation under the FDCA addresses the design of test systems to help ensure that their results are clinically valid and support safe and effective patient care.”
- The FDA also states that the case at issue is not subject to the rule of lenity as there are no statutory ambiguities to resolve. Additionally, the agency states the major questions doctrine does not apply as “this is an ordinary case of federal regulation pursuant to unambiguous Congressional authorization, not an extraordinary one presenting major political, economic, or federalism questions.”
- The agency cites lack of available evidence to support the claim that FDA phaseout of the general enforcement discretion approach and chosen targeted enforcement discretion policies were “arbitrary and capricious.”
- If the plaintiffs succeed in challenging the rule, the FDA notes that the text of the APA does not require the agency to vacate the rule.
Following the FDA filing of the brief, the court denied the plaintiff’s motions to vacate the final rule. The case will proceed.
Sources:
https://documents.cap.org/documents/fda-brief-20241026.pdf
https://documents.cap.org/documents/court-order-20241026.pdf
