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US House and Senate Reintroduce Bill That Would Give FDA Authority to Regulate LDTs

NEW YORK – The US House of Representatives and Senate reintroduced on Thursday a bill that would create a new regulatory framework for laboratory-developed tests, or LDTs, giving the US Food and Drug Administration authority over these tests.

The bill, called the Verifying Accurate, Leading-edge IVCT Development, or VALID, Act of 2021, would create a new risk-based oversight framework for so-called in vitro clinical tests, a category comprising lab-developed tests and test kits, and would give the FDA authority to regulate these tests.

Originally introduced in March 2020, the bill was reintroduced in the Senate by Sen. Richard Burr, R-North Carolina, and Sen. Michael Bennet, D-Colorado, and in the House by Rep. Diana DeGette, D-Colorado, and Rep. Larry Bucshon, R-Indiana.

The act would settle the long-running debate within the industry as to the FDA's authority over LDTs.

The Federal Food, Drug, and Cosmetic Act gives the FDA authority to regulate devices, which the agency has historically argued includes LDTs and gives it broad authority to stipulate requirements for test providers (or exempt them from requirements) during emergencies. However, the FDA has largely practiced "enforcement discretion" over most LDTs and left the Centers for Medicare & Medicaid Services to oversee labs under CLIA.

In August 2020, the US Department of Health and Human Services issued a determination that the FDA cannot require premarket review of LDTs without notice and comment rulemaking.

This decision by HHS recapitulated a claim made for years by many in the laboratory industry that the FDA cannot expand its authority over LDTs through guidances but must do so through notice-and-comment rulemaking, a much more involved process. Guidances, historically, have been the FDA's preferred method of articulating its regulatory requirements over segments of the lab industry.

While the HHS statement did not preclude the FDA from regulating LDTs through notice-and-comment rulemaking, some observers suggested the agency wouldn't take such a route, given the investment in time and effort required.

Reintroduction of the bill follows the reintroduction in May by US Sen. Rand Paul, R-Kentucky, of the Verified Innovative Testing in American Laboratories, or VITAL, Act, which offers an alternative approach to LDT regulation that would place their regulation under the authority of HHS as opposed to the FDA.

In a statement, American Clinical Lab Association President Julie Khani commended the legislators for their work on the issue of diagnostic regulation but also indicated that the organization was in favor of requirements that test regulation be done through notice-and-comment rulemaking as per the HHS determination.