The House Energy and Commerce Subcommittee on Health held a Feb. 8 hearing on the Advanced Research Projects Agency for Health (ARPA-H), an initiative proposed by President Joe Biden to utilize the Defense Advanced Research Projects Agency (DARPA) as a model to foster faster development of novel treatments, diagnostics, cures, and preventive measures to improve health.
Subcommittee Chair Anna Eshoo (D-Calif.) introduced authorizing legislation, the ARPA-H Act (H.R. 5585) in October 2021, which would make ARPA-H a new entity within the Department of Health and Human Services (HHS) [refer to Washington Highlights, Oct. 22, 2021]. During the hearing, Eshoo stated that she would work with Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.), authors of the broader health care delivery legislation, the Cures 2.0 Act (H.R. 6000) [refer to Washington Highlights, Nov. 19, 2021], to advance both bills through the committee markup process in the near future. DeGette, Eshoo, and Upton issued a press release after the hearing outlining their agreement to plan to work together to advance the ARPA-H and Cures 2.0 Acts.
During the hearing, witnesses presented perspectives from medical research, health care delivery, patient advocacy and DARPA. There were no witnesses representing the administration following the Feb. 7 resignation of White House Office of Science and Technology Policy Director Eric Lander, PhD, after White House investigations revealed Lander’s history of bullying subordinates.
Subcommittee members asked questions regarding the logistics of establishing ARPA-H, the types of projects that would be best suited in the model initiative, and how to ensure workforce diversity.
A main point of discussion during the hearing was whether to house ARPA-H within the National Institutes of Health (NIH), as the president proposed, or as a new independent entity, as proposed in the ARPA-H Act.
Keith Yamamoto, PhD, vice chancellor for science policy and strategy at the University of California, San Francisco, stated that ARPA-H needs to look and act differently than the NIH, and should “embrace bold approaches, [and] tolerate failure…” He continued, “At the same time, though, NIH must continue to thrive for ARPA-H to succeed. Thus, Congress should install safeguards to prevent ARPA-H funding from supplanting NIH investments or threatening its culture. “
Executive director of FasterCures and the Center for Public Health at the Milken Institute Esther Krofah, MPP, advocated for ARPA-H to be established within the NIH, noting that it could complement existing agency-industry partnerships, including the RADx program and the NIH’s National Center for Advancing Translational Sciences.
While members from both sides of the aisle expressed support for ARPA-H, some Republican lawmakers raised concerns that it would be duplicative of existing research agencies like the NIH and expressed frustration over inquiries they have posed to NIH about the COVID-19 pandemic. “Before we give the executive branch more authority and resources, let’s make sure we can get answers on what’s being spent today and why,” full committee chair Cathy McMorris Rodgers (R-Wash.) said.
In response to a question from subcommittee Ranking Member Brett Guthrie (R-Ky.) about the need that ARPA-H would fill, Geoffrey Shiu Fei Ling, MD, PhD, CEO of On Demand Pharmaceuticals and professor of neurology at Johns Hopkins Medicine, replied, “There are 10,000 known diseases, only 700 cures and treatments, that's a pretty big gap. … The private sector is actually quite conservative. And the point is that early government investment can yield a huge amount of private industry pull.”
Admiral Brett P. Giroir, MD, former HHS assistant secretary for health and former director of DARPA’s Defense Sciences Office, agreed with other witnesses that ARPA-H should be independent of the NIH and noted the importance of adhering to strict milestones and timelines and nurturing a “culture of innovation … where there is no disincentive for failure, only for not being bold enough.”
Krofah testified that an advisory committee with diverse stakeholders including representatives from the patient community, academia, and industry, would be needed. Giroir also emphasized the importance of program managers engaging with their communities.
Rep. Dan Crenshaw (R-Texas) raised concerns that ARPA-H would not address core innovation problems in other agencies like the Centers for Medicare & Medicaid Services and the Food and Drug Administration, which he noted play key roles in payment policies for new health products. Ling replied that all federal health agencies need to innovate, and that ARPA-H could be helpful in encouraging innovation across federal agencies.