- The 21st Century Cures legislation -- a significant FDA and drug development reform bill expected to usher in some of the biggest regulatory changes to healthcare since the passage of the Affordable Care Act -- will not be decided upon before the Senate heads to recess.
- With time running short, Senate health committee Chairman Lamar Alexander (R-TN) is holding out hope that the Senate will pass the 21st Century Cures bill in September.
- Senate Majority Leader Mitch McConnell (R-KY) also wants to pass the bill this year, Alexander said late Monday.
- The House passed its version of the FDA reform and medical innovation legislation in July 2015.
All eyes have been on this bill since its formal introduction in January, and for good reason: The measure would speed up drug development efforts, provide more funding to the NIH and FDA, grant exclusivity to orphan drug products, make it easier for pharma companies to make the economic, value-based case for their drugs to providers, integrate patient voices into the regulatory and drug development process, and much more.
“This could be the most important legislation Congress passes this year, and there’s no excuse for not finishing our work in September,” Alexander said in a statement. The measure would include funding for President Barack Obama’s precision medicine initiative and Vice President Joe Biden’s “cancer moonshot” program.
But despite widespread support, Alexander’s announcement makes clear that the bill won’t come to a floor vote before lawmakers leave town for their summer recess.
Earlier this year, the health committee passed a series of smaller bipartisan bills aimed at speeding up FDA approval of new treatments and getting them to patients more quickly. The committee wrapped up markups on biomedical innovation bills on April 6, optimistically declaring that the Cures bill could reach the Senate floor the following week.