Hearing Challenges FDA Rule on LDTs
House Energy and Commerce Health Subcommittee chair Brett Guthrie (R-KY) told a 3/21 hearing that he cannot support FDA’s proposed rule on oversight of laboratory-developed tests (LDTs) and said it should be withdrawn while legislative proposals are crafted to address outstanding challenges with such devices. “As diagnostic testing becomes more complex, I believe it is essential that Congress work with the public health community, physicians, and patient groups to address any current challenges with providing patients with the highest-quality diagnostics without stifling innovation,” he told the hearing.
A committee memo reviews the history of the oversight of LDTs from 1976 to 2006, when FDA first indicated its intent to regulate them through a draft guidance for only in vitro diagnostic (IVD) multivariate index assays, to the 9/29/2023 FDA proposed rule to make explicit that all IVDs are considered to be medical devices under the Federal Food, Drug, and Cosmetic Act, including when the test manufacturer is a laboratory. The memo says the final rule has been under review with the Office of Management and Budget and is expected to be published in April.
Ranking member Anna G. Eshoo (D-CA) told the hearing that the tests Americans rely on should be safe and effective and ”I think that’s something we all agree on which is why I support the FDA’s intent to bring certainty to diagnostic tests by requiring lab developed tests to go through more rigorous review processes. However, I don’t believe the FDA’s proposed rule is the only way to achieve our shared goal, and the device 510k review process is not perfectly tailored for LDTs.”
Eshoo noted that the previously considered VALID Act (see earlier story) “establishes a specific framework for regulating diagnostic tests, similar to how drugs are approved and monitored for safety or quality issues. The legislation also directs a report on the unique challenges academic medical centers and hospital-based labs face. I believe the FDA’s proposed rule should reinvigorate discussions on the legislation and call all stakeholders back to the table to earnestly negotiate the framework.”
FDA’s proposal to regulate laboratory-developed tests would “undermine innovation and reduce access to effective and appropriate care for patients, the American Hospital Association (AHA) said in a 3/21 statement that was introduced into the record. “While we support the need for additional oversight of the development and use of some LDTs and in-vitro diagnostics offered as LDTs, the FDA’s proposal to apply its device regulations to hospital and health system LDTs is misguided,” AHA said “These tests are not devices — they are diagnostic tools developed and used for essential patient care. Regulating LDTs under the FDA’s device regulatory framework could cause patients to lose access to many critical tests and stifle innovative advances in hospital and health system laboratory medicine.”
AHA is urging FDA to continue to apply its enforcement discretion to hospital and health system LDTs and defer regulation of these tests mainly to the Centers for Medicare & Medicaid Services’ strict Clinical Laboratory Improvement Amendments (CLIA) oversight, the College of American Pathologists accreditation and state law. “Enforcement discretion is particularly important for low- and moderate-risk LDTs, including modifications to FDA-approved IVDs, the group said. “Modifications improve the performance of approved diagnostic tests on certain patient populations, address problems or issues with FDA-approved devices, and allow the latest research and clinical knowledge to be rapidly incorporated. They are intended to improve testing accuracy and safety. If the laboratory is following the CLIA regulations and is subject to the factors described above, low- and moderate-risk tests, including modifications to commercially marketed IVDs, should be exempt from FDA regulatory oversight.”
Advanced Medical Technology Association’s Zach Rothstein told the hearing that the device industry agrees that improvement to the current regulatory structure through legislative reform is necessary to “modernize the device framework so that it is tailored to provide an appropriate, risk-based oversight program for innovative IVDs—including test kits, LDTs, and the instruments upon which these assays (tests) run. Indeed, the current regulatory framework for diagnostics was established decades ago and has remained fundamentally unchanged despite dramatic advancements in the field.” He said legislative reform should “spur innovation and access to testing and is applied to all diagnostic tests based on their level of risk.”