December 2016
This week, the Senate approved a large health research package known as the 21st century Cures Act by a bipartisan vote of 94 – 5, following passage by the House late last week by a similar bipartisan vote of 392 – 26. The major intent of the bill is to speed discovery and FDA approval of new therapies and cures but it encompasses other health-related provisions, many of which are of interest to the ATS including funding for NIH and the FDA as well as mental health legislation and measures to address opioid addiction. The bill includes the following:
- $4.8 billion in funding for NIH's Precision Medicine Initiative, Cancer Moonshot, BRAIN Initiative and regenerative medicine research
- PATH Act – a measure to create a new expedited FDA approval pathway for new antibiotics (a key request at ATS Hill Day 2016) with limited patient populations
- Renewal of the FDA rare pediatric disease incentive program
- Renewal of the NIH's National Pediatric Research Network focused on rare diseases and birth defects
- Creation of an expedited approval pathway for breakthrough medical devices
- Initiatives for young investigators including creation of a new NIH office of Next Generation Researchers and increasing the NIH loan repayment award from $35,000 to $50,000
- Measures to reduce the administrative burden on researchers
- Improvements in the FDA and NIH scientists' ability to attend scientific conferences.
President Obama strongly supports the legislation and will sign the 21st Century Cures Act into law shortly. The ATS supported the legislation although we were disappointed that the bill did not provide funding for all NIH institutes, did not clarify physician payment sunshine reporting rules, and that it rescinds future funding for the Affordable Care Act's Prevention and Public Health Fund, a key source of state tobacco cessation services and education funding.
