21st Century Cures Act now law

Yesterday, President Obama signed the 21st Century Cures Act into law. The bill passed both houses of Congress with overwhelming bipartisan support.

The 21st Century Cures Act is nearly 1,000 pages with 25 separate Titles, or sections. Titles I and II deal specifically with the National Institutes of Health and the conduct of basic research. Other parts of the bill focus on policies affecting the NIH and the Food and Drug Administration, conduct of clinical trials, drug development, and improving mental-health support infrastructure.

Title I directs the Department of the Treasury to create an account called the “NIH Innovation Account” and to set aside specified amounts of money into the Account from 2017 through 2026. Disbursing funds from the Account is at the discretion of Congressional appropriators.

The projects the money disbursed from the Account can be used for are completely accounted for in the legislation. Those projects are the Precision Medicine Initiative, the BRAIN Initiative, cancer research and a regenerative medicine project.

  • PMI and BRAIN: Funding trends are nearly identical and they are funded from FY18 through FY26. Funding will oscillate between $25 and $135 million from FY18 through FY21. Funding spikes to over $500 million in FY23 and declines to the end of the program in FY26.
  • Cancer research: This project will be funded by the account from FY17 through FY22. This project will receive all of the money set aside in the Account in fiscal 2017. There will be a spike in FY19, and funding will decline until FY22.
  • Regenerative medicine project: This project is only funded from FY18 to FY20, receiving $10 million each year.

Title II has several sections important for the biomedical research workforce and the conduct of science. One section establishes an office in the NIH Office of the Director that will develop, coordinate and prioritize NIH policies to promote the independence of young researchers. The office would also be tasked with coordinating similar efforts among other agencies federal agencies as necessary. The language in this section is vague enough to give the NIH discretion as to the function of his office and what it might do to improve the training of young researchers. This section also directs the NIH to examine the report from the Next Generation Researchers initiative and report to Congress on implementing the group’s recommendations.

Another section codifies efforts to reduce administrative burden for researchers. The bill establishes a board of researchers tasked with identifying and eliminating or harmonizing duplicative or burdensome regulations. This follows the publication of a National Academies report earlier this year on relieving regulatory burden.

The 21st Century Cures Act is an important piece of legislation, and it will have far-reaching effects on the conduct of biomedical research in the U.S. Stay tuned to the Rescuing Biomedical Research blog as we chart the implementation of the parts of this bill pertaining to the biomedical research workforce.