More than 160 million Americans live with one or more chronic conditions, many of which lack effective treatments.
The National Health Council (NHC) is leading patient advocacy organizations to support legislative efforts that focus on making sure that limited health care research dollars are spent most effectively to encourage medical innovation that will meet the needs of patients.
21st Century Cures
The 21st Century The 21st Century Cures Act was signed by President Obama in December 2016. The bill, spearheaded by the House Energy and Commerce Committee and Senate Health, Education, Labor, and Pensions Committee will advance the discovery and development of treatments for unmet medical needs, strengthen patient engagement in the regulatory process, and improve the innovation ecosystem. The NHC and over 200 other patient organizations sent a letter to Congressional leadership and President Obama, urging action on the legislation before the end of 2016.
FDA User Fees
The NHC has been a longstanding supporter of using user fees to support the development of patient-centered initiatives at the Food and Drug Administration (FDA).
In the Prescription Drug User Fee Act (PDUFA) VI agreement, there are many provisions that the NHC supports. Notably, the NHC supports the requirement to develop patient engagement guidance, the exploration of Real World Evidence’s (RWE’s) potential use in clinical development, improving the qualification of biomarkers and surrogate endpoints, expansion of the rare disease program, and improvements to the FDA’s hiring and retention processes.
Similarly, the Medical Device User Fee Amendments (MDUFA) IV agreement includes provisions related to patient engagement and RWE.
Both agreements must be passed by Congress and signed into law by September 30, 2017.