NEW YORK – US Sen. Rand Paul (R-Kentucky) on Wednesday introduced a bill seeking to keep regulation of laboratory-developed tests out of the hands of the US Food and Drug Administration.
The bill, called the Verified Innovative Testing in American Laboratories (VITAL) Act, strikes a counterpoint to another bipartisan-backed bill that was introduced earlier this month in the Senate and House of Representatives, called the Verifying Accurate, Leading-edge IVCT Development (VALID) Act. While VITAL seeks to update existing federal lab standards under the Clinical Laboratory Improvement Amendments (CLIA), VALID would create an entirely new risk-based oversight framework for so-called in vitro clinical tests, a category comprising lab-developed tests and test kits, and bring them all under FDA's aegis.
Specifically, VITAL states that all aspects of lab-developed testing procedures would be regulated by the US Health and Human Services Secretary under the Public Health Services Act, and 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."
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 LDTs, and left the Centers for Medicare & Medicaid Services to oversee labs under CLIA.
Paul and other supporters of the bill are taking 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. The FDA has been particularly criticized for requiring test developers and manufacturers get Emergency Use Authorization from the agency prior to launching testing (see in-depth feature on the history of LDTs debate).
"As witnessed with the 2020 COVID-19 pandemic, undue regulation of laboratory-developed testing procedures may hamper the medical management and public health response to infectious disease outbreaks and pandemics, leading to delays in access to testing and the ability to meet needed capacity to stem community spread," according to the bill's language. VITAL goes on to articulate that the federal government should ensure that regulations won't hinder patients' access to LDTs or impede labs' ability to develop and quickly adapt tests when needed.
The Association for Molecular Pathology has held the position that reforms to the present oversight of lab tests should focus on updating CLIA, and that the FDA shouldn't impose duplicative requirements for labs. "The delayed response to the current coronavirus pandemic perfectly illustrates the importance of clinical laboratories in being able to develop and provide novel testing services," said AMP President Karen Weck in a statement.
The FDA, however, has defended that it has worked closely with labs and manufacturers to remain flexible during the public health crisis. The agency issued guidance on Feb. 29 and again earlier this week, significantly expanding the ability of manufactures, LDT developers, and state authorities to launch tests with limited or no federal oversight.
In introducing VALID, its 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 also made the case that the bill is needed in light of the present public health situations. When the bill was released 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.
The bill aims to reduce the regulatory burden on labs through extensive grandfathering and exemption clauses. The bill also introduced a relatively new regulatory concept, called technology precertifications, that would allow labs to take a representative test or platform through premarket review and forgo premarket review for all other tests that fall under the same category as the representative test for a time.