A bipartisan bill that would establish a framework for overseeing diagnostic testing at the Food and Drug Administration (FDA) was introduced in the U.S. House of Representatives.
Public health officials have long called for greater oversight of diagnostic testing. Health care providers and patients rely on diagnostic tests to make decisions about the best course of care and treatment. This bill — the Verifying Accurate, Leading-edge IVCT Development, or VALID, Act — seeks to increase the reliability of those tests by giving the FDA the additional tools it needs to properly oversee the marketplace.
The bill would create a new product category for diagnostic and lab tests, putting their review and approval under the FDA. Further, it would overhaul how the FDA reviews and approves diagnostic tests. Also, it would give laboratories greater flexibility to respond to public health emergencies.
The legislation was introduced by U.S. Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN).
“What we have learned over the years in successfully combatting the spread of viruses, such as MERS, SARS, and Ebola, is that time is of the essence,” DeGette said. “Ensuring that our hospitals and laboratories across the country have the tools they need to quickly and accurately [diagnose] patients is essential to help prevent the spread of these viruses throughout our communities. This legislation will overhaul the federal government’s outdated system that is slowing down our ability to respond to these threats – and it will ensure that hospitals around the country are able to begin testing patients for these potentially deadly viruses as soon as possible.”
The VALID Act would also create a new system for hospitals and labs to submit their tests electronically to the FDA for approval. This would speed up the time it takes for the agency to approve such tests and expedite the development of new diagnostic tests.
“Advanced diagnostics are transforming the way we provide care for patients in the 21st century,” Bucshon said. “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. With the help of the VALID Act, the future of precision medicine will enable physicians to provide more individualized patient care to discover, cure, and treat diseases that were previously unknown and untreatable.”
An identical bill – sponsored by Sens. Michael Bennet (D-CO) and Richard Burr (R-NC) – was also introduced in the U.S. Senate.