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NEW YORK US Sen. Rand Paul, R-Kentucky,on Tuesday reintroduced a bill that would prevent the US Food and Drug Administration from regulating laboratory-developed tests.

The bill, called the Verified Innovative Testing in American Laboratories, or VITAL,Act of 2021, would place regulation of lab-developed tests under the authority of the US Health and Human Services secretary under the Public Health Services Act, and "no aspects of lab-developed testing procedures shall be regulated under the Federal Food, Drug, and Cosmetic Act, including during a public health emergency."

The FD&C 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 LDTsand left the Centers for Medicare & Medicaid Services to oversee labs under CLIA.

Paul originally introduced the bill in March of 2020. It represents an alternative to the Verifying Accurate, Leading-edge IVCT Development, orVALID,Act that was introduced that same month in the Senate and House of Representatives, but which did not receive a vote during that session of Congress. The VALID Act would have created a new risk-based oversight framework for so-called in vitro clinical tests, a category comprising lab-developed tests and test kits. The FDA would have authority over these tests.

Both the VITAL and VALID acts would settle the long-running debate within the industry as to FDA's authority over LDTs.

Paul and other supporters of the bill have taken the position that VITAL is needed to update CLIA and keep LDTs away from burdensome FDA oversight in light of the slow federal response to expand access to SARS-CoV-2 virus tests during the present pandemic. This argument has gained momentum in the year since Paul originally introduced the bill. HHS in August 2020 issueda 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 guidancesbut 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.

The Association for Molecular Pathology, or AMP,and the Association of Pathology Chairs, or APC,issued statements Tuesday supporting the passage of VITAL.

"This important support by members of Congress for the VITAL Act addresses the serious consequences experienced by our nation when laboratory tests are regulated like medical devices," said Lydia Howell, the president ofAPC. She is also a professor and chair of pathology and laboratory medicine at the University of California Davis School of Medicine.

"In the earliest and most frightening days of the pandemic, CLIA-accredited academic clinical laboratories could have used their valuable expertise and resources to expand SARS-CoV-2 diagnostic testing in their communities, but were unable to do so due to inappropriate FDA restrictions.Priceless weeks were lost, making the urgency to address these issues now even more clear," she added.

Read more:
Rand Paul Reintroduces Bill Aimed at Blocking FDA Regulation of LDTs - 360Dx