21st Century Cures Act Becomes Law

In a display of bipartisanship, Congress passed the 21st Century Cures Act. The House overwhelmingly passed an updated version of the bill (H.R. 34) on November 30 by a vote of 392 to 26. On December 7, the Senate followed suit with its consideration of the bill and passed it by a recorded vote of 94 to 5. President Obama signed the bill on December 13. The comprehensive bill provides an infusion of funding for biomedical research at the National Institutes of Health (NIH), directs the Food and Drug Administration (FDA) to approve drugs and devices with greater urgency, provides resources to states to assist in fighting the opioid epidemic, and provides a boost for mental health care.

The bill reauthorizes the NIH for FY 2018 through FY 2020, including $34.851 billion in FY 2018, $35.585 billion in FY 2019, and $36.472 billion in FY 2020. The nearly thousand-page bill retains the many of the provisions passed by the House in 2015. The most notable change to the revamped bill is the creation of an “NIH Innovation Account” that specifies annual funding levels for the next ten years (2017 -2026), described as a “trust fund” that would have to be approved annually by appropriators. The funding appropriated from the Innovation Account, however, will not count against budget caps. Those funds would be provided via the Prevention and Public Health Fund and Strategic Petroleum Reserves.

The Innovation Account would provide a total of $4.796 billion over ten years (including $352 million in FY 2017) for the following research areas: $1.4 billion for the Precision Medicine Initiative; $1.6 billion for the Brain Research through Advancing Innovative Neurotechnologies Initiative (BRAIN); and $1.8 billion to support cancer research. Senate Republicans renamed this portion of the bill to honor Vice President Joe Biden’s son, Beau Biden, who died of brain cancer in 2015. Vice President Biden has been leading the Administration’s Cancer Moonshot initiative. The bill would also provide $30 million for NIH in coordination with the Food and Drug Administration for regenerative medicine using adult stem cells.

Additionally, the bill would require NIH to submit an annual work plan to Senate Health, Education, Labor, and Pension Committee, the House Energy and Commerce Committee, and the House and Senate Appropriations Committees detailing the proposed allocation of funds. This work plan is expected to include a description and justification for each proposed project as well as “a description of how each such project supports the strategic research priorities identified in the NIH Strategic Plan.”

The revised legislation also would provide $1 billion over a two-year period for the opioid epidemic. The funds would go to states to “supplement opioid abuse prevention and treatment activities.” The activities supported by the grants include those “implementing prevention activities, and evaluating such activities to identify effective strategies to prevent opioid abuse.”

The 21st Century Cures Act also addresses mental health and incorporates the Helping Families in Mental Health Crisis Reform Act of 2016, which among other things would create an Assistant Secretary for Mental Health and Substance Abuse to head the Substance Abuse and Mental Health Services Administration (SAMHSA). Other mental health provisions in the Cures bill provides funding for suicide-prevention programs, mental health services for children, and programs for court-ordered outpatient treatment.

Other provisions in the 21st Century Cures Act would:

  • Exempt NIH research from the Paperwork Reduction Act.
  • Ease restrictions on NIH researchers attending scientific meetings.
  • Increase the loan repayment cap.
  • Provide NIH the authority to “require grant recipients to share the data that is generated from NIH-funded research.”
  • Create a “Next Generation of Researchers Initiative” to “improve opportunities for new researchers.” NIH is required to report to Congress any actions it takes in response to a FY 2016 mandated National Academy of Sciences’ study “on policies affecting the next generation of researchers.”
  • Require NIH to develop a six-year strategic plan that includes consideration of the U.S. disease burden, rare disease, and biological and social determinants of health.
  • Require the Office of Management and Budget (OMB) to establish the “Research Policy Board” advisory committee to reduce administrative burden related to federal research requirements. The Board is to recommend ways to “modify and harmonize regulations.”
  • Provide NIH an “other transactions authority” for the Precision Medicine Initiative for up to 50 percent of the fund in the Common Fund.
  • Require the NIH director to “improve research related to minority populations.”
  • Encourage the Director of the National Institute of Minority Health and Health Disparities (NIMHD) “to foster partnerships and encourage the funding of collaborative research projects.”
  • Require the NIH Director to convene a workshop “to get input on appropriate age groups in research and update policies.”
  • Establish five-year renewable terms for NIH institute directors.

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Posted in Issue 23 (December 13), Update, Volume 35 (2016)

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