Lawmakers introduce legislation to expand nation’s diagnostic testing capabilities

Mar 5, 2020
Press Release
Move comes as health care workers scramble to increase testing for coronavirus

WASHINGTON, D.C. – U.S. Reps. Diana DeGette (D-CO) and Larry Bucshon, M.D. (R-IN) introduced bipartisan legislation today to increase the diagnostic testing capabilities of health laboratories across the country, in part to better respond to emerging public health threats, such as the novel coronavirus.

The move comes after public health officials complained for weeks that a current Food and Drug Administration policy – which requires labs to get prior FDA approval before they test patients for the coronavirus – was impeding their abilities to quickly diagnose – and, if necessary, quarantine – potential cases here in the U.S.

The FDA announced Saturday that it had temporarily lifted the pre-approval requirement for such tests and is now allowing certain hospitals across the country to immediately begin testing patients for the virus.

DeGette and Bucshon’s legislation would, among other things, make that change permanent. And, by overhauling how the FDA reviews and approves diagnostic tests going forward, it seeks to give laboratories greater flexibility to respond to such public health emergencies going forward, while continuing to keep patients safe.

“What we have learned over the years in successfully combating 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 diagnosis 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 This legislation will overhaul the federal government’s outdated system that is slowing down our ability to respond to these threats – and it will ensure that hospitals around the country are able to begin testing patients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.”

While it is common for hospitals to develop and use their own tests to diagnose patients, when a national public health emergency is declared – such as the coronavirus – hospitals are required to submit any tests they plan to use to diagnose the emerging threat to the FDA for approval before they can be used to screen patients.

This process of having to wait for the FDA’s approval of tests is, in part, what has delayed health care workers’ ability to begin immediately screening patients in their communities.

In addition to permanently removing the pre-approval requirement for national emergencies going forward, the legislation – known as the Verifying Accurate, Leading-edge IVCT Development, or VALID, Act – would create a new product category for diagnostic and lab tests, putting their review and approval under the guise of the FDA going forward.

It would also create an entirely new system for hospitals and labs to use to submit their tests electronically to the FDA for approval, a move designed to dramatically speed up the amount of time it takes for the agency to approve such tests – while, at the same time, increasing their quality and reliability. And it would establish a program to expedite the development of new diagnostic tests that can be used to address a current unmet need for patients.

Public health officials have long called for greater oversight of diagnostic testing, especially in the face of several high-profile scandals involving companies such as Theranos.

Health care providers and patients routinely use, and increasingly rely on, diagnostic tests to make difficult decisions about the best course of care and treatment. This new legislation is designed to increase the reliability of those tests by giving the FDA the additional tools it needs to properly oversee the marketplace.

To ensure the legislation in no way interferes with patients’ ability to receive testing that’s already proven to provide reliable results, the legislation would grandfather in any current diagnostic test that’s already being used by health care professionals.

The legislation has bipartisan support in both chambers of Congress. In addition to the legislation DeGette and Bucshon introduced in the House, an identical version of the bill – sponsored by U.S. Sens. Michael Bennet (D-CO) and Richard Burr (R-NC) – was also introduced today in the Senate.

A copy of the legislation DeGette and others introduced today is available here.

A section-by-section summary of the bill is available here.