The Senate Health, Education, Labor, & Pensions Committee (HELP) kicked off the first of three committee meetings on its "Biomedical Innovation" agenda by passing seven bills, all with bipartisan support, on February 9, 2016.
Supporters believe these new healthcare bills are key counterparts to the 21st Century Cures Act (Cures Act), which was passed by the House in 2015. The Cures Act amends the Public Health Service Act in order to reauthorize the National Institutes of Health (NIH) through fiscal year 2018.
The Cures Act also establishes the NIH and Cures Innovation Fund to appropriate funds: (1) for biomedical research, including high-risk, high-reward research and research conducted by early stage investigators; (2) to develop and implement a strategic plan for biomedical research; and (3) to carry out specified provisions of this Act.
The new healthcare bills, among other things, streamline the US Food and Drug Administration’s (FDA) review process for innovative medical devices, bolster FDA's oversight of reusable devices, accelerate the approval process for some “targeted” rare disease drugs, and aid the National Institutes of Health (NIH) efforts in early research. Http://raps.org/regulatory-focus/news
The next HELP meeting is scheduled for March 9, where the committee will debate and vote on at least five bipartisan bills.