June 2015 Council Currents


21st Century Cures/Dormant Therapies:

As expected, the House Energy and Commerce (E&C) Committee approved HR 6, the 21st Century Cures Act, with unanimous support. The next step is for other committees of jurisdiction to consider the bill. E&C leaders hope to have a full House vote in June. The bill includes several issues championed by the National Health Council (NHC), including the incorporation of patient experience data, improved data sharing of patient information, streamlining the institutional review board (IRB) process for multi-site clinical research, and increased funding for the National Institutes of Health. However, the NHC-crafted proposal on dormant therapies was dropped.

Patient Engagement in Drug Development:

The Hill newspaper and PhRMA recently hosted a program entitled “From Hope to Cures,” which included a panel discussion about the FDA’s patient-focused drug development program. Participants included representatives from the NHC, FDA, FasterCures, and Friends of Cancer Research. Click here to view the video.

State Enhancements of Health Insurance Exchanges:

The NHC and Avalere Health have worked together to create a series of state-specific progress reports on Affordable Care Act implementation to demonstrate which states are creating the most patient-friendly marketplaces. The first set of 32 reports was publically released on March 20, and the NHC is finalizing reports for all 50 states and the District of Columbia. The reports measure a state’s specific performance across the following five principles: non-discrimination, transparency, state oversight, uniformity, and continuity of care. For more information about the initiative and to view the reports, click here.

PDUFA/MDUFA Reauthorization:

FDA has announced a schedule of public meetings to hear from stakeholders on reauthorizing the Medical Device User Fee Amendments-MDUFA (July 13) and the Prescription Drug User Fee Act-PDUFA (July 15). The NHC has been invited by the FDA to present at both meetings.

NHC Welcomes New Members:

The NHC is pleased to welcome the National Association of State Mental Health Program Directors Research Institute into membership as a Nonprofit member and Amgen as a Business and Industry member.

Chief Development Officers Webinar:

Two representatives from Charity Navigator updated the NHC’s Chief Development Officers Affinity Group on plans to change CN’s rating system. The webinar recording can be viewed on the web. The webinar also included an update on the Physician Payment Sunshine Act and its impact on Voluntary Health Agencies.