NEW YORK – Lawmakers from the House and Senate on Thursday introduced legislation intended to establish a framework for US Food and Drug Administration oversight of diagnostic testing.
Called the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, the law was introduced by Reps. Larry Bucshon, R-Ind, and Diana DeGette, D-Colo., members of the House Energy & Commerce Committee, and creates a new test product category, in vitro clinical tests, or IVCTs, which comprise test kits and laboratory-developed tests, and gives FDA authority to review and approve these IVCTs.
An identical version of the bill was introduced in the Senate, sponsored by Sens. Michael Bennet, D-Colo., and Richard Burr, R-N.C.
The bill would resolve longstanding questions over FDA's authority to regulate LDTs. The agency has historically exercised enforcement discretion over LDTs, leaving the Centers for Medicare & Medicaid Services to oversee them under the Clinical Laboratory Improvement Amendments. However, it has maintained that it has the authority to regulate these tests, an assertion challenged by many in the lab and pathology business who have maintained that FDA oversight of LDTs would hinder innovation and harm patients.
Bucshon and DeGette (D-CO) first released a draft of the VALID Act in December 2018. That draft represented a revision of a previous bill, the Diagnostic Accuracy and Innovation Act (DAIA), that they had previously written with significant input from the lab and diagnostics industry.
The VALID Act creates a risk-based framework for IVCT regulation, with high-risk tests, like novel assays, required to go through premarket review, while lower-risk tests could go to market after passing through technological certification.
The law would grandfather in existing LDTs being used clinically.
"The VALID Act establishes a risk based regulatory framework that allows for leading edge development and innovation to thrive, while assuring doctors and patients that their test results are analytically and clinically valid. This will ensure that patients receive the most appropriate medical advice or treatment," Representative Bucshon said in a statement.
Scott Whitaker, president and CEO of AdvaMed, applauded the legislation. "It’s time to modernize the law for diagnostics, regardless of where or how they are developed, to keep up with the rapid pace of diagnostic medical technology innovation," he said in a statement.
The bipartisan VALID Act calls for smart diagnostics regulatory reforms that will incentivize and speed the development of the advanced, reliable tests that benefit the patients we serve."
American Clinical Laboratory Association President Julie Khani was more cautious, saying in a statement that the association and its members are currently focused on the SARS-C0V-2 situation unfolding in the US but will review the VALID Act in the coming days.
ACLA and its members have been "actively working with stakeholders to advance meaningful comprehensive diagnostic reform for patients" for several years, and have consistently maintained that "a modernized regulatory framework must ensure sustained innovation for patients and providers and support continued access to the laboratory tools necessary for the diagnosis, monitoring, and treatment of disease."
The three main priorities, she added, are reform that recognizes that diagnostics are distinct from medical devices and that there are differences between LDTs and IVDs; grandfathering and transitioning policies that protect patient access to currently available LDTs; and a regulatory system that balances innovation and "appropriate regulatory oversight."