NAEVR Comments on 21st Century Cures Act 2.0 Draft

On July 13, NAEVR submitted comments to House Energy & Commerce Committee members Diana DeGette (D-CO) and Fred Upton (R-MI) who, on June 22, issued a press release and “Discussion Draft” for the proposed Cures 2.0 legislation that would update the 21st Century Cures Act, passed in December 2016, to improve how new medical treatments and therapies are delivered to patients.

The legislation includes a section that would authorize the Advanced Research Projects Agency-Health (ARPA-H), President Biden’s proposed new research institute in Fiscal Year (FY) 2022 funding that would be modeled on the Defense Advanced Research Projects Agency (DARPA). In addition, the Cures 2.0 draft legislation also included the Research Investment to Spark the Economy (RISE) Act, which would provide $25 billion for “research relief” to federal research agencies, including $10 billion to the National Institutes of Health (NIH).

In its comments, NAEVR:

  • Acknowledged that the Alliance had endorsed the 21st Century Cures Act in 2016, which included the creation of an Innovation Fund to support NIH-wide initiatives (Cancer Moonshot, Precision Medicine Initiative, BRAIN Initiative, and Regenerative Medicine Initiative).
  • Expressed appreciation for inclusion of the Research Investment to Spark the Economy (RISE) Act in the legislation. NAEVR noted that, at the May 26, 2021, Senate Labor, Health and Human Services, and Education (LHHS) Appropriations Subcommittee hearing, NIH Director Francis Collins, MD, PhD estimated the COVID-19 pandemic-related loss to the NIH biomedical enterprise at $16 billion, $6 billion more than the $10 billion loss he estimated at the Subcommittee’s July 2, 2020, hearing.
  • Stated that, as Congress considers how to establish ARPA-H, the authorizers and appropriators should explore mechanisms that can balance new investment in ARPA-H with continued robust support for the NIH base budget that funds promising science across all Institutes and Centers (I/Cs), the Innovation Fund that supports 21st Century Cures Act initiatives, and early-stage investigators.
  • Urged that an ARPA-H framework consider accelerated translation of a wide variety of life-saving and quality-of-life enhancing research across the NIH—not just cancer, Alzheimer’s, and diabetes, as stated in the President’s budget request. NAEVR noted that, at the May 25, 2021, House LHHS Appropriations Subcommittee hearing, Dr. Collins stated that “all I/Cs would be involved in the work of ARPA-H, offering up their best ideas for rapid translation of research that would benefit all Americans.”