Secretary of Health and Human Services (HHS) Xavier Becerra announced the establishment of the Advanced Research Projects Agency for Health (ARPA-H) within the National Institutes of Health (NIH) and appointment of its acting deputy director on May 25.
The related Federal Register notice highlighted the reorganization of the NIH to oversee ARPA-H and details several organizational and functional elements of the new research entity, including its role in providing “leadership for high-risk, high-reward biomedical and health research.” The notice also highlighted the duties of several support offices including:
- The Treatment Innovation Office, to further develop “novel and innovative therapeutics or other interventions.”
- The Health Equity, Dissemination, and Implementation Office with several roles including advancing programs that “concentrate on promoting health equity, access to care, and ethical aspects of science and technology development.”
- The Health Data Office, to facilitate best practices for the collection, organization, integration, and utilization of scientific and health data.
- The Equity and Inclusion Office, charged with coordinating, facilitating, and supporting programs “to ensure equity, diversity, and inclusion in all aspects of ARPA-H’s work.”
Becerra also named Adam Russell, DPhil, as the acting deputy director of the new initiative, with an anticipated start date of June 6. Russell currently serves as the chief scientist at the University of Maryland's Applied Research Laboratory for Intelligence and Security and previously served in the Intelligence Advanced Research Projects Activity and the Defense Advanced Research Projects Agency. Becerra added that President Joe Biden is working to appoint the ARPA-H director.
The announcements from the HHS came one week after the House Energy and Commerce Committee marked up and approved an amendment in the nature of a substitute to Health Subcommittee Chair Anna Eshoo’s (D-Calif.) bill to authorize ARPA-H, the Advanced Research Project Agency-Health Act (H.R. 5585) [refer to Washington Highlights, May 20].
The amendment approved by the Energy and Commerce Committee included several notable changes from the original bill as introduced, including:
- A requirement that ARPA-H be reestablished outside of the NIH but within the HHS upon the bill being signed into law.
- Protections for information gathered from awardees, including plans for commercialization, third-party investments, and revenue gained from research conducted under the award.
- A requirement for timely information sharing with the Centers for Medicare & Medicaid Services to assist in coverage determinations and with the Food and Drug Administration to get therapies more quickly to patients.
- A requirement for indirect facilities and administrative costs related to an award to be made publicly available.
- Assurance that funded animal studies meet federal research requirements and include statistical modeling to justify animal samples sizes.
- A disclosure by awardees whether the primary investigator participates in foreign talent programs.
- A requirement for the director to prioritize awards to domestic recipients.
- Authorization of an annual appropriation of $500 million for each fiscal year from 2023 through 2027 and removal of language regarding advanced appropriations for the entity.