Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) released a discussion draft of the Cures 2.0 Act —legislation aimed at accelerating medical research and patient access to novel therapeutics — on June 22, just as the administration released additional materials regarding President Joe Biden’s Advanced Research Projects Agency for Health (ARPA-H) proposal.
Leaders from the White House Office of Science and Technology Policy and the National Institutes of Health (NIH) released a fact sheet and commentary in Science magazine with additional details on the administration’s vision for ARPA-H. The White House materials discuss the proposed initiative’s concept and mission using the Defense Advanced Research Projects Agency as a model, the proposed structure of ARPA-H within the NIH, and the congressional authorities ARPA-H would need to fulfill the initiative’s goals.
Meanwhile, the Cures 2.0 discussion draft would build upon the 21st Century Cures Act (P.L. 114-255) that was passed in 2016 [refer to Washington Highlights, Dec. 8, 2016] with the updated legislation aiming to improve and modernize health care access and delivery, including a placeholder to authorize ARPA-H within the NIH [refer to Washington Highlights, June 4, June 17].
In a joint press release, DeGette and Upton stated that the government “has amazing resources at its disposal and now is the time to put the full weight of those resources to use to cure some of the world’s most devastating diseases.” They added that the president and first lady are “determined to find new cures and treatments for these difficult diseases and we couldn’t be more excited to be working with them to make this dream come true.”
Aside from the placeholder for ARPA-H, the discussion draft covers several themes related to medical research, public health, and health care delivery, including:
- The Research Investment to Spark the Economy Act (H.R. 869, S. 289), which would provide one-time funding to enable federal research agencies to address pandemic-related impacts to research progress and has been endorsed by the AAMC [refer to Washington Highlights, April 30].
- Public health and pandemic preparedness measures, including increasing surveillance, testing, and vaccination capabilities as well as efforts to better understand long COVID-19.
- Caregiver integration into the patient care team.
- Increasing diversity in clinical trials.
- Food and Drug Administration modernization, including innovative clinical trial design and increased communication with the Centers for Medicare & Medicaid Services (CMS) regarding breakthrough therapy drugs.
- CMS changes, including increased access to telehealth, increased coverage for breakthrough therapies, and increased access to genetic testing.
DeGette and Upton are seeking stakeholder feedback on the ARPA-H proposal before releasing a final bill following Congress’ August recess. The lawmakers released an initial concept paper for Cures 2.0 in April 2020 during the 116th Congress that did not include provisions related to ARPA-H, research recovery, or long COVID-19 [refer to Washington Highlights, May 1, 2020]. The concept paper incorporated stakeholder input solicited in December 2019, to which the AAMC submitted recommendations [refer to Washington Highlights, Dec. 19, 2019].