In the News

A bipartisan group of lawmakers last week distributed draft legislation that would give the FDA authority to regulate laboratory-developed tests. The draft was released by Reps. Larry Bucshon, R-Ind., and Diana DeGette, D-Colo., retiring Senate Finance Committee Chairman Orrin Hatch, R-Utah, and Sen. Michael Bennet, D-Colo. Current law gives the CMS authority over lab-developed tests, but the draft bill would charge the FDA with approval authority of the diagnostic tests and lab development tests – a move FDA Commissioner Scott Gottlieb called for last March. The draft bill won’t be finalized before Congress finishes its term this month. Instead, Bucshon said he hopes that after input from stakeholders, final legislation can be introduced next year.