21st Century Cures Act

HR 6, the 21st Century Cures Act:  Renewed optimism for patients and researchers.

What is this 21st Century Cures Act?

This new bill in the House of Representatives is in the early stages of the legislative process. However, it has gone through more than a yearlong developmental process.  The latest version of the bill has been reduced to 199 pages.  Importantly, the Energy and Commerce Committee approved the bill unanimously on May 21 by a vote of 51-0, with obvious and enthusiastic bipartisan support!  When the bill came up for consideration before the entire House, the vote remained overwhelmingly bipartisan—members who voted in favor 344, against 77, abstain 12.

What is the Congress proposing in this new bill?

The current iteration of the bill has three main components: Discovery, Development, and Delivery.

Title 1 focuses on “Discovery”.

The 21st Century Cures Act has several goals that should energize academic physicians and scientists.  The bill proposes to re-invest in discovery research by increasing the NIH budget—currently $30.3 billion.  The committee proposes to increase the NIH budget to $31.8 billion in 2016; $33.3 billion in 2017; and $34.8 billion in 2018.  Importantly, the proposed NIH budget grows predictably over the next 3 years:  total increase is $4.5 billion (nearly 15%).

The 21st Century Cures Act also creates a dedicated innovation fund of an additional $2 billion/year from 2016 through 2020. This represents another $10 billion “to support biomedical research through funding of basic, translational, and clinical research” at the NIH.  This component of the NIH budget allows congressional appropriators to invest additional resources in scientific research without impacting current budget caps (per sequestration).

The 21st Century Cures Act is prescriptive in that it directs the NIH to invest in specified priority areas.  The bill specifies support for innovative research in such areas as biomarkers, precision medicine, infectious diseases, and antibiotics, for example.  In other priority areas, the 21st Century Cures Act directs the NIH to reserve funding specifically for “young emerging scientists”.  This subtitle in the Act includes also specific language regarding improved loan repayment programs.  Furthermore, the bill directs the NIH to create “capstone awards” to support the work of particularly outstanding scientists previously funded by the NIH.

Another priority area in the 21st Century Cures Act includes pediatrics research and directs the NIH to establish a “national pediatrics research network”. The network would be composed of research institutions operating as a consortium in order to pool resources and coordinated activities related to research on rare diseases or birth defects.  The bill also declares a “sense of Congress” that directs the NIH and FDA to work together and with the European Union, industry, and others to establish a “global pediatrics clinical trials network”.

The 21st Century Cures Act identifies other priority areas.  The bill specifies the need for the NIH to engage “in scientifically based strategic planning implemented in support of research priorities”.  This is a recurring requirement to be repeated at 5-year intervals.  In addition, the bill directs the NIH to improve access to clinical trials data by creating and then releasing de-identified clinical trials data sets, from qualified clinical trials, for use by other medical investigators.

These budget issues and priority areas represent some of the key features included in the current version of the 21st Century Cures Act.  Now that the House has acted, what will the Senate choose to do?

For additional information visit: http://energycommerce.house.gov/cures

COMING next: The 21st Century Cures Act, Title 2 “Development”