Today, the U.S. House of Representatives passed H.R. 6, the 21st Century Cures Act, with a bipartisan vote of 344-77. A bipartisan effort led by Energy and Commerce Committee Chairman Fred Upton (R-MI) and Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairman Joe Pitts (R-PA) and Ranking Member Gene Green (D-TX), and Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-CO), the legislation is intended to accelerate “the discovery, development and delivery of life saving and life improving therapies.”
Proponents of this legislation will now turn all of their attention to Senate Health, Education, Labor, and Pensions Chairman Lamar Alexander (R-TN) who plans to advance his own version of the same legislation in the fall of 2015 or early 2016.
According to a fact sheet issued by Rep. Upton, key elements of the legislation include:
- Removing barriers to increased research collaboration
- Incorporating the patient perspective into the drug development and regulatory review process
- Measuring success and identifying diseases earlier through personalized medicine
- Modernizing clinical trials
- Providing new incentives for the development of drugs for rare diseases
If enacted, the bill would also establish an Innovation Fund, “a dedicated and offset funding stream of $1.75 billion per year for 5 years for the NIH and $110 million per year for 5 years for the FDA that will allow congressional appropriators to invest additional resources without impacting current budget caps.” Earlier this week, however, the Obama administration expressed concerns over certain funding components of the legislation, including provisions that would require the sale of oil from the Strategic Petroleum Reserve.