The first draft of the legislation was released in late January, and after receiving feedback from experts and stakeholders, the committee is planning to move forward on the legislation.
21st Century Cures was launched last year ago by Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.) with the goal of speeding-up the FDA’s clinical testing process.
The bipartisan group of supporters, which includes Reps. Marsha Blackburn (R-Tenn.), Gene Green (D-Texas), Greg Walden (R-Ore.) and G.K. Butterfield (D-N.C.), among others, argue that if the FDA’s approval process for new medications and treatments was shorter, some patients with life-threatening illnesses could be saved.
But the proposal is not without its critics.
Former FDA Commissioner Margaret Hamburg, who stepped down earlier this month, has criticized the proposal, raising concerns that speeding up the process could cause harm to patients.
At a National Press Club event in March, Hamburg said the proposal is built on the “misconception that you might be able to speed up innovation by lowering the standards for safety and efficacy.”
So far, the committee has held eight hearings and four roundtable discussions in Washington D.C. The committee has also met with stakeholders, experts and the Obama Administration. Some lawmakers, including Rep. Cathy McMorris Rodgers of Washington, have hosted discussions about the initiative in their districts.