House Energy and Commerce Committee considers legislation on NIH and FDA

21st Century Cures bill looks to boost NIH funding in new ways

The House Energy and Commerce Committee will mark up a major health bill the week of May 19:  the 21st Century Cures Act.  It is meant to boost biomedical innovation through authorizing additional funding and making regulatory changes at National Institutes of Health (NIH) and Federal Drug Administration (FDA).  This bill has gotten a lot of attention for the bipartisan way in which it was conceived and the bipartisan hearings and listening sessions conducted by Rep. Fred Upton (R-MI) and Rep. Diana DeGette (D-CO), both senior members of the committee.

You may recall that the discussion draft of the bill, issued in January, was not received with universal acclaim by scientific organizations, and the Democratic members of the Energy and Commerce Committee did not endorse it. Several changes were made in the discussion draft before it was introduced as a bill. For example, it no longer sets out fixed terms for directors of NIH institutes and centers.

The American Psychological Association’s primary interest in the bill centers on its NIH provisions.  As it stands now after the Health Subcommittee mark- up, the bill reauthorizes the NIH for three years at the following levels:

  • FY 2016 -- $31.811 billion
  • FY 2017 -- $33.331 billion
  • FY 2018 -- $34.851 billion

Remember that these levels in an authorizing bill represent the ceiling up to which the Appropriations Committees may provide funds.  So the 21st Century Cures Act gives NIH spending room to grow but only the Appropriations Committees may provide the NIH with money to spend. The NIH’s appropriation for the current Fiscal Year 2015 is $30.1 billion.

The bill would also authorize a five-year, $10 billion NIH Innovation Fund, with $2 billion per year in mandatory appropriations routed through the NIH Director. The bill tasks the Innovation Fund with various specific purposes including the development of a new Accelerating Advancement Program, research funding tied to a specific project or objectives, research funding for innovative scientists and early stage investigators, high-risk high-reward research, research funding for small businesses, and the NIH intramural program.  Where would these funds come from?  The Committee leadership has said it will announce a source for the funds (aka “pay-fors”) before the full Committee marks up the bill.

Finally, the bill makes the entire Innovation Fund contingent upon adoption of the NIH strategic plan, which is also required in the legislation. (In fact, NIH has already begun working on an overall Strategic Plan, as required by the FY 2015 funding bill.)

The legislation would allow the NIH Director to require NIH grantees to share their data, and would require NIH to standardize certain patient inclusion and exclusion information across all trials housed in ClinicalTrials.gov to enhance patient searches for ongoing trials.

The bill also has many provisions focused on FDA and its Patient-Focused Drug Development (PFDD) program.  It is possible additional funds may be provided for FDA to carry out the bill’s new mandates but the details will depend on how the Congressional Budget Office scores the bill after the funding sources are revealed.

It looks as though the markup will occur on Thursday May 21.  The Majority Memorandum, legislation, and amendments will be available here as they are posted. But if quickly finding $10 - 13 billion in spending offsets turns out to be a challenge, the mark-up may be postponed.