The latest updates and analysis from Morrison Foerster
October 28, 2022 - Health Care

U.S. Government Launches Billion-Dollar Biomedical Agency

New DCMA Defective Pricing Pilot Team Will Possess Audit Resolution Authority

New Agency Sets Ambitious Goals to Transform Biomedicine and Health

As part of the Biden Administration’s ongoing efforts to spur innovation and research, it has championed the creation of a new sub-agency within the Department of Health and Human Services, the Advanced Research Projects Agency for Health (ARPA-H). Authorized by Congress in March 2022, the new agency will bring together industry, academia, and government through public-private partnerships for high-risk, high-reward endeavors intended to drive breakthroughs in biomedicine and health. ARPA-H seeks to capitalize and expand on recent advances in biomedicine to revolutionize the prevention and treatment of cancer, infectious diseases, and Alzheimer’s and other diseases, and potentially to uncover cures. Its impact on Americans could be profound.  

Among the potential early projects that ARPA-H has identified are efforts to develop mRNA cancer vaccines, wearable blood pressure and blood sugar monitors, and systems to help eliminate racial disparities in maternal morbidity and mortality. The agency’s focus is very broad, and it intends to leverage its unique position to fill gaps across the United States’ biomedical research ecosystem. The breadth of innovation that the agency plans to undertake is, in part, the byproduct of a series of listening sessions that the White House and National Institutes of Health (NIH) held last year, which included more than 5,100 stakeholders.

Structurally, ARPA-H is an independent agency within NIH in the U.S. Department of Health and Human Services. The agency will model its approach to the award of grants and contracts on the process used by the Defense Advanced Research Projects Agency (DARPA). With the inaugural director recently announced, one of the agency’s next priorities will be identifying a diverse cohort of program managers, assembled from industry, academia, and other sectors, to implement the agency’s vision. Like DARPA, ARPA-H plans to seek broad, flexible funding authority and to use an adaptable and permissive proposal review process. While the specific parameters of the process are still in development, an analogy may be the process used by the Biomedical Advanced Research and Development Authority (BARDA), another agency within the HHS, which we described in detail in this article.

As the new agency takes shape, it remains clear that it has the strong backing of the Biden Administration. President Biden’s proposed fiscal year 2023 budget included $5 billion for ARPA-H—a notable increase over the $1 billion that Congress allocated in 2022. Somewhat relatedly, the administration further demonstrated its commitment to biotechnology and biomanufacturing by issuing an Executive Order in September 2022 on “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” which introduces the National Biotechnology and Biomanufacturing Initiative. While the Initiative’s mission goes beyond that of ARPA-H―including climate change, energy, food security, agriculture, supply chains, and national security in addition to health―the EO is further evidence of increasing investment in biotechnology research and development and manufacturing capabilities.

We will continue to monitor the development of ARPA-H, and will provide further updates as opportunities for biotech and health companies to partner with the agency, and to receive funding to further its ambitious goals, become available.

Cody Kornack, a Law Clerk in our Washington, D.C., office, contributed to the writing of this alert.