21st Century Cures

21st Century Cures 2017-04-25T19:14:09+00:00

21st Century Cures Act

The 21st Century Cures bill passed the Senate by 94-5. The House held their signing ceremony on December 8.  The bill was signed by the President on Tuesday, December 13, 2016 at the White House.

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As expected, the bill contains a great deal of detail on NIH under Division A including the following topics:

  • the reauthorization of the Agency, requiring a 6-year strategic plan,
  • Triennial reports to congress,
  • increased accountability through term appointments,
  • supporting young emerging scientists,
  • review of regulations and policies,
  • reproducibility issues,
  • high risk/high reward research grants,
  • expanding NCATS support of clinical trials (CTs),
  • increased collaboration and coordination,
  • researching pregnant women and importance of demographic data (inclusion) in CTs, greater access to data,
  • pediatric research.

Highlights of the bill:

  • It provides $4.8B over 10 years to NIH (through the Office of the Director) that will be for the Cancer Moonshot ($1.802bil), the BRAIN Initiative ($1.564bil) and the Personalized Medicine Initiative ($1.4bil) which is allocated annually.  Funding will be from the Prevention and Public Health Fund ($3.5bil) and the rest from drawing down from the Strategic Petroleum Reserve.
  • It provides $500mil over 10 years to FDA and additional $30 mil to FDA for regenerative medicine.
  • Continues Patient-Focused Drug Development at FDA and increases reporting of patient experience.

Why This Matters

The bill provides critically needed funding for the NIH, Cancer Moonshot, the BRAIN Initiative, PMI, and the FDA. It allows research to be funded that would not happen through any other mechanism. For patients, it means an increase in clinical trials and a greater emphasis on women’s reproductive health. For researchers, it provides support for young researchers and expands grant opportunities to engage in high risk/high reward research. The bill also requires greater reporting accountability to ensure funds are being spent effectively.