On March 21, 2024, the Health Subcommittee of the House Energy & Commerce Committee held a hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” In the wake of repeated congressional inaction on the Verifying Accurate Leading-edge IVCT Development Act or the “VALID Act” (S. 2209/H.R. 2369), which would establish a new regulatory framework for in vitro diagnostic (IVD) tests, FDA issued a Proposed Rule late last year that, if finalized, would phase out its long-standing enforcement discretion approach for so-called “laboratory developed tests” (LDT), subjecting them to the same enforcement approach as other IVDs. As noted by Ranking Member Anna Eshoo during the hearing, this is the “sixth year for Congress to be grappling with the VALID Act—we have not acted validly.” The hearing served as yet another reminder of the established view, held by nearly every stakeholder in the diagnostic test ecosystem—including FDA—that the preferred approach is for Congress to address the regulation of LDTs in statute, thereby alleviating the need for FDA to move forward with its Proposed Rule and creating long term regulatory certainty for stakeholders.
Under FDA’s regulations, IVDs are defined as “reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae, and intended for use in the collection, preparation, and examination of specimens taken from the human body.” For nearly 50 years, FDA has considered LDTs—a subset of IVDs that are designed, manufactured, and used within a single laboratory—to be medical devices under the Federal Food, Drug, and Cosmetic (FD&C) Act. However, given that LDTs were historically considered to be lower risk and used in small volumes for patient populations within a single health system, FDA had exercised enforcement discretion over most LDTs, opting not to enforce many of the requirements of the FD&C Act, including premarket review. In the Proposed Rule, FDA asserts that regulation of LDTs needs to evolve based on an array of changes in more recent years to LDT technology, business practices, increased usage and criticality of LDTs in clinical decision-making.
Hearing witnesses included representatives from American Clinical Laboratory Association (ACLA), Advanced Medical Technology Association Dx (AdvaMedDx), College of American Pathologists (CAP), Friends of Cancer Research (FOCR), and the Academic Coalition for Effective Laboratory Developed Tests. Notably, FDA did not participate in the hearing. While there were clear disagreements among the witnesses on how (and whether) LDTs should be regulated by FDA, all witnesses agreed that Congress should act to establish a fit-for-purpose regulatory regime by legislation.
Witnesses expressed varying degrees of concern with the FDA Proposed Rule. ACLA and CAP underscored their view that FDA lacks the resources to keep up with the influx of device review submissions that would be required under the Proposed Rule, creating review backlogs which would result in discontinuation of currently used LDTs, decreased innovation in new diagnostics and exacerbations of long-standing inequities in health care, further marginalizing underserved populations like children and those living with rare diseases. Both groups also noted the significant cost labs would incur in complying with FDA’s proposal, likely resulting in widespread consolidation of labs.
Despite the prevalent opposition to FDA’s proposal on display at the hearing, no witness defended the status quo with respect to LDTs. FOCR’s Dr. Jeff Allen repeatedly stressed the risks to patients and significant system costs of unreliable cancer tests that render inaccurate diagnoses and lead to inappropriate treatments. He noted that nothing is precluding Congress from advancing legislation in the face of FDA’s advancement of the Proposed Rule and stated “[n]o matter the path forward, action to ensure high-quality test performance is needed, and progress to that end can no longer be stalled. The future of precision medicine — and the health and lives of patients depends on the accuracy of these tests.”
Overall, the hearing underscored the widespread agreement that some version of the VALID Act should move forward and that its risk-based, tailored approach to in vitro diagnostics, which allows for grandfathering of many currently marketed LDTs, is preferable to FDA’s Proposed Rule.
Meanwhile, FDA has been taking steps to finalize the Proposed Rule. On March 1, 2024, the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB) received the draft of the Final Rule for review and clearance, and has scheduled numerous meetings with stakeholders to discuss the topic. Given the clear and strongly held views by the array of LDT stakeholders that new legislation is necessary and the finalization of FDA’s rule is misguided, it seems this may be the optimal moment for Congress to act.
