LDTs

VITAL Act Would Eliminate FDA Regulation of New Tests During Health Emergencies

In standing aside and allowing test makers to validate and perform COVID-19 laboratory developed tests (LDTs) and not wait for Emergency Use Authorization (EUA), the FDA has actually acknowledged what the diagnostics industry has been arguing for years, namely, that agency overregulation of LDTs is an obstacle to test development and innovation. But the irony of the situation isn’t lost on one US Senator who introduced a bill that would make the accelerated pathways approach being taken for COVID-19 test development a permanent part of public health emergency response. Here’s the lowdown.

FDA Regulation of LDTs during Health Emergencies

LDTs developed, validated and performed inside the same lab are normally regulated under CLIA. The Federal Food, Drug and Cosmetic Act, by contrast, doesn’t expressly give the FDA authority to regulate lab tests. However, while largely leaving lab regulation to CMS under CLIA, the agency has long argued that its regulatory oversight of medical devices extends to LDTs, including broad authority to stipulate requirements for test providers (or exempt them from requirements) during Public Health Emergencies (PHEs).

Accordingly, as part of its initial response after declaring a PHE for COVID-19 on Jan. 31, the federal government set aside CLIA and required that all tests for the novel coronavirus obtain an EUA from the FDA before they could be used on patients, largely the same pattern followed in previous PHEs. The FDA also stuck with its usual strategy of issuing EUA for a federal government test within a week of the declaration, in this case, a reverse transcriptase real-time PCR developed by the CDC, authorizing only public health labs and the Department of Defense labs to use the test. But problems with the initial CDC kit led to a weeks-long delay until the CDC issued a new one, with labs having to spend that critical time wrestling with bureaucratic approval in the EUA process to use their own tests, depleting needed resources.

The good news is that the FDA responded by loosening the strings and allowed labs to validate and perform LDTs for COVID-19 without first securing agency EUA. (See the related story on page X). But precious time had been lost.

 A New FDA-Less Pathway for LDTs

Against this backdrop, Senator Rand Paul (R-KY) introduced the Verified Innovative Testing in American Laboratories (VITAL) Act of 2020 on March 17, 2020, to establish a new pathway to make tests quickly and widely available during PHEs. Specifically, the bill would let labs develop and use tests within days, providing a better opportunity to isolate, contain and understand viruses.

Paul and supporters of the bill believe that VITAL is necessary to update CLIA by removing LDTs from FDA oversight in light of the slow federal response to expand access to SARS-CoV-2 virus tests during the present pandemic. The FDA has been criticized for requiring test developers and manufacturers to get EUA from the agency prior to launching testing. “When we face a health emergency, government should trust academic, community and public health labs to do what they are already trained and certified to do,” noted Senator Paul in a press release. “With all of the debates about how government should respond, here’s one thing it can stop doing: piling counter-productive bureaucratic hurdles in the way of our medical professionals.”

The 4 Things the VITAL Act Does

Dr./Senator Paul’s plan would institute a legislative fix that allows labs to follow the CLIA process even during public emergencies, helping prevent delays and waste of time and money.  Specifically, VITAL:

  • Clarifies that the Public Health Service Act governs all aspects of laboratory-developed testing procedures — including during a PHE;
  • Requires CMS to hold a public meeting to solicit recommendations on updating the CLIA regulations within 90 days of enactment;
  • Requires the Secretary of HHS to report to Congress, within 180 days of enactment, recommendations to update the CLIA and their associated regulations, and about the availability and utilization of LDT procedures during the 2020 COVID-19 pandemic. The COVID-19 assessment would have to include information about:
    • The average length of time from validation to achieving EUA before and after February 29, 2020;
    • The number of patients and samples tested by labs using these procedures; and,
    • Recommendations to ensure that in future outbreaks, the public health system and clinical laboratories don’t encounter delays to testing.
  • Expresses the Sense of Congress that labs using LDTs should adhere to personnel requirements under §353 of the Public Health Service Act, and the federal government should work to:
    • Ensure that patients receive the most appropriate tests for medical evaluation and treatment;
    • Ensure that lab-developed testing is accurate, precise, clinically-relevant and monitored for quality performance;
    • Enable lab professionals to provide their services without undue restrictions;
    • Ensure that oversight of LDTs doesn’t limit patient access, impede innovation, constrain flexibility or limit the sustainability of tests;
    • Preserve the ability of the lab community to provide surge capacity in PHEs, including biological, chemical, radiological and nuclear threats, infectious disease outbreaks or other emergent situations; and
    • Safeguard, strengthen and expand the existing Laboratory Response Network.

VITAL vs VALID

The VITAL Act strikes a counterpoint to another bipartisan-backed bill introduced earlier this month in the Senate and House of Representatives called the Verifying Accurate, Leading-edge IVCT Development (VALID) Act (See NIR, March 18, 2020, for details about VALID.) While VITAL updates existing federal lab standards under CLIA, VALID would create an entirely new risk-based oversight framework for in vitro clinical tests, a category comprising LDTs and test kits, and bring them all under the FDA’s aegis.

VALID sponsors in the House (Reps. Larry Bucshon (R-Indiana) and Diana DeGette (D-Colorado)), and in the Senate (Richard Burr (R-North Carolina) and Michael Bennet (D-Colorado)), have made the case that VALID is needed in light of the present public health situations. When VALID was introduced on March 5, Bucshon argued that during a public health crisis the government must act quickly to ensure hospitals and labs can develop tests to identify those infected and stop the spread of the virus. He added that VALID “will overhaul the federal government’s outdated system that is slowing down our ability to respond to these threats.”

VALID would effectively end the longstanding disagreements between the FDA and the lab industry about whether the agency has the statutory authority to regulate LDTs. It would also end the agency’s historic practice of “enforcement discretion” over LDTs, and instead, implement a new framework that brings all clinical tests under its oversight.

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