Thursday, March 5, 2020

Very Brief Blog: VALID ACT to be unveiled soon on Hill

Brief reports in Bloomberg Law News and Politico Pulse state that the long-debated VALID ACT, for regulatory reform of FDA vis-a-vis lab tests, will be unveiled soon.

Politico Pulse here.
Bloomberg Law here.

Sponsors include Rep. Bucshon (R-IN) and DeGette (D-CO) and Sen. Burr (R-NC) and Bennet (D-CO). 

Politico writes in part:

BIPARTISAN BILL WOULD OVERHAUL LAB TESTS — A bipartisan, bicameral group will soon unveil legislation to overhaul how the FDA regulates laboratory developed tests and in vitro diagnostics, putting them under one framework as "in vitro clinical tests," POLITICO's David Lim scoops.... major revamp of an FDA proposal for a precertification program — now deemed "technology certification." It also creates a breakthrough program similar to medical devices to speed development and prioritize review of certain tests, as well as a user fee program to support test review.

It's an armful: a 245-page version of the bill has begun circulating.