Devices

Bill to Improve Diagnostic Test Regulatory Impediments

U.S. Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN) have introduced the bipartisan Verifying Accurate, Leading-edge IVCT Development Act that is intended to increase diagnostic testing capabilities to better respond to emerging public health threats, like the coronavirus. The bill would codify FDA’s recent temporary policy to permit certain laboratories to use validated diagnostics before the agency has completed the review of their Emergency Use Authorization (EUA) requests. “The FDA can issue an EUA to permit the use, based on scientific data, of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition when there is a determination, by the Secretary of Health and Human Services (HHS), that there is a public health emergency or a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens, and a declaration that circumstances exist justifying the medical products’ emergency use,” an FDA release explaining the policy says.

The lawmakers’ legislation comes after public health officials complained for weeks that FDA’s previous policy – which requires labs to get prior FDA approval before they test patients for the coronavirus – was getting in the way of labs being able to quickly diagnose potential cases in the U.S. It would, among other things, make the temporary policy 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,” the representatives said in a release.

“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,” the lawmakers said. “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.” The bill would also create an entirely new system for hospitals and labs to use to submit their tests electronically to FDA for approval, a move designed to dramatically speed up the amount of time it takes for the agency to approve such tests. Additionally, 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.

An identical version of the bill – sponsored by sens. Michael Bennet (D-CO) and Richard Burr (R-NC) – was also introduced in the Senate.

A copy of the legislation is available here. A section-by-section summary is available here.

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