Yesterday, the 21st Century Cures bill was unanimously passed by the House Energy and Commerce Committee. 21st Century Cures would overhaul how the Food and Drug Administration evaluates new medical products and provide $10 billion in mandatory funding for the National Institutes of Health.
Passage by the Committee is a significant milestone for this important piece of legislation. The bill contains many provisions that would directly impact the SMA community, including a provision on patient input into risk/benefit analysis, and a provision on expanded access in clinical trials.
It is expected that 21st Century Cures will be brought to the House floor for a full vote in June.
The Senate is also working on legislation called “Innovation” that will address many of the same issues as 21st Century Cures. The effort is being led by Richard Burr and Lamar Alexander and will go through the Senate Health, Education, Labor and Pensions Committee. The Senate is working on a much slower timeline and it is expected that there will not be any significant movement until the fall.
Once 21st Century Cures has been voted on by the House, and the companion bill has been voted on by the Senate, leaders from both bodies will meet to create a unified bill that will need to be passed again by both bodies and then sent to the President to be signed. House champions have indicated that would like to see this happen before the end of 2015.