A bipartisan group of lawmakers is launching another bid to overhaul how the FDA regulates certain tests and diagnostics

Jun 23, 2021
In The News

A bipartisan, bicameral group is reintroducing tweaked legislation Thursday that would overhaul how the FDA oversees laboratory-developed tests and diagnostics, POLITICO’s David Lim reports.

The VALID Act would regulate both lab tests and diagnostics under a new framework clarifying the responsibilities of the FDA and CMS. Reps. Larry Bucshon (R-Ind.) and Diana DeGette (D-Colo.) are backing the bill in the House, with Sens. Michael Bennet (D-Colo.) and Richard Burr (R-N.C.) sponsoring the Senate version.

“We can’t allow an outdated and inefficient system to hold us back when trying to respond to an emerging threat, such as the coronavirus,” DeGette said in a statement.

The effort follows scrutiny over how the government regulates medical tests, after the Trump-era HHS last year tried to limit the FDA’s oversight of certain tests developed and used by individual labs.

But it could take months for legislation to find its way to the floor. Multiple congressional aides told David that it’s more likely the bill would be included in FDA user fee reauthorizations that will come up in 2022.