LDT Regulation Issue Rekindled with Reintroduction of VITAL Act

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The longstanding issue of how to regulate laboratory developed tests (LDTs), which last year sparked two competing bills in Congress, has returned to Capitol Hill with the reintroduction of one of the two measures.

Sen. Rand Paul, M.D. (R-KY) has brought to the U.S. Senate the Verified Innovative Testing in American Laboratories (VITAL) Act of 2021. The measure (S. 1666) would keep LDT oversight outside of the FDA by directing that “no aspects of lab-developed testing procedures shall be regulated under the Federal Food, Drug, and Cosmetic Act, including during a public health emergency.”

Following reintroduction of the VITAL Act on Tuesday, the bill was referred to the Senate’s Committee on Health, Education, Labor, and Pensions (HELP).

This year’s VITAL Act is identical to the bill introduced by Paul last year. The VITAL Act would update federal lab standards under the Clinical Laboratory Improvement Amendments (CLIA), overseen by the U.S. Department of Health and Human Services (HHS)—through which LDTs would also be regulated under the Public Health Services Act, which gives HHS authority to respond to public health emergencies.

Defending the VITAL Act’s provision keeping LDTs from FDA oversight, Paul and supporters of the measure cite the agency’s initially slow response to expanding access to SARS-CoV-2 tests beyond public health labs and Department of Defense labs. The FDA later required that every test marketed to screen for or diagnose the disease, including LDTs, must first receive an EUA from the agency—then revised its rules again by allowing labs to bring a test to market immediately, as long as they applied for an EUA within 15 days.

“The requirement of qualified clinical laboratories to obtain an FDA EUA prior to performing COVID-19 diagnostic tests was a drastic and unnecessary addition to the substantial regulatory requirements that were already in place,” Mary Steele Williams, Executive Director of the Association of Molecular Pathology (AMP), told Clinical OMICs.

“Experienced, high-quality laboratories found that the FDA set impossible-to-meet requirements, such as the need for laboratories to evaluate more positive samples than the actual number of confirmed cases in the U.S,” Williams said. “Significant barriers to obtaining an EUA still remain after FDA’s policy eventually changed to allow for the immediate use of LDPs after they had been validated via existing regulatory mechanisms.”

Williams cited an August 2020 AMP survey which found that almost a third of laboratories experienced similar hurdles while seeking an EUA. “The VITAL Act would ensure that even in a pandemic, laboratories using LDPs could continue to operate under the CLIA system, which will help ensure access to these potentially life-saving tests.”

AMP’s more than 2,500 members practice various molecular diagnostics disciplines, including bioinformatics, infectious diseases, inherited conditions, and oncology.

Two Weeks Apart

Last year, Paul introduced the VITAL Act two weeks after four lawmakers, two from each major party, proposed bringing LDTs and test kits under FDA oversight under a new category of “in vitro clinical tests” (IVCTs) through the Verifying Accurate and Leading-edge IVCT Development (VALID) Act. Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO) introduced the U.S. House of Representatives version while the VALID Act was introduced in the Senate by Sens. Michael Bennet (D-CO) and Richard Burr (R-NC), the ranking member of the Senate’s HELP committee.

To date, the VALID Act has not been reintroduced.

Since last year, Congress has become even more divided along partisan lines. Democrats control the Senate with 50 Senators and Vice President Kamala Harris, and the House by a 219-211 majority over Republicans, with five seats vacant.

Asked how AMP will build support for the VITAL Act given the sharpened partisan divide, Williams said: “AMP has had a number of positive conversations with offices on the Hill, and there is a lot of interest in this area due to the continued focus on clinical diagnostic testing for COVID-19.

“We hope that our work will continue to inform the conversations about this topic because AMP, as well as others, are interested in legislation that provides clarity and transparency,” Williams said. “This has been a challenging and ever-changing regulatory environment for our members who are trying to respond to patient need. “

The VALID Act won support from an industry group representing test developers. AdvaMedDx, the diagnostics manufacturers’ division of the Advanced Medical Technology Association (AdvaMed), asserted that its advocacy of legislation would benefit multiple stakeholders beyond test developers by eliminating uncertainty and clearing up the FDA’s role in test regulation.

Earlier this year, AdvaMedDx said it sought the reintroduction of an “improved” VALID Act and would work to get it through Congress, according to a statement of its priorities for 2021.

AdvaMed wrote: “Diagnostics regulatory reform would provide clarity to regulatory oversight of all in vitro clinical diagnostics tests – both the IVD tests manufactured by AdvaMedDx members for the commercial market that are currently regulated by the [FDA] as medical devices and not specifically as diagnostics, as well as diagnostics tests developed by laboratories, including hospital laboratories, known as [LDTs], which, under current HHS interpretation, are not subject to FDA premarket review absent notice-and-comment rule making.”

“Establishment of a single, predictable regulatory framework tailored to all clinical diagnostics tests would include modernized regulatory pathways and policies to foster innovation in diagnostics development to speed patient and clinician access to the latest diagnostics,” AdvaMedDx added.

The FDA touched off the issue of LDT regulation in 2014 when it proposed regulating “high-risk” LDTs along the lines of Class III medical devices, through draft guidances friendlier to for-profit diagnostic developers than they were to nonprofit academic medical centers. Within a year, both sides responded with regulatory counterproposals, and by 2016 the agency ended its rulemaking attempt.

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