The White House and some members of Congress have been pushing to establish an advanced research agency around health and biomedicine this past year. Now that members of Congress have started to consider funding to stand up the new agency, Congress is exploring how to structure the mission and governance behind it.
The idea behind the Advanced Research Projects Agency for Health — dubbed ARPA-H — began when President Joe Biden proposed establishing the agency in the White House fiscal year 2022 budget, requesting $6.5 billion over three years for ARPA-H. He pitched for the agency to serve as high-risk, high-reward biomedical research agency, modeled after the military’s Defense Advanced Research Projects Agency.
Now that members of Congress have started to include support for ARPA-H and advancements in health through the 21st Century Cures 2.0 Act and ARPA-H Act, the House Energy and Commerce Committee held a hearing last week to make the moonshot research agency a reality.
Rep. Anna Eshoo, who chairs the Health Subcommittee and introduced the ARPA-H bill, argued that biomedical research is currently divided between basic research that the National Institutes of Health has long helmed, and the biomedical innovation landscape driven by corporations aiming to commercialize scientific discoveries with market potential. She said that ARPA-H will fill gaps between the two by driving new innovation go beyond the risk that NIH and private industry take.
“My legislation proposes ARPA-H to be made up of highly empowered program managers who are not career government employees, but are instead experts in their field, who dedicate their time to short-term projects for long-term results,” Eshoo said.
Those testifying before the subcommittee overall argued in favor of establishing ARPA-H, but each biomedical research expert offered varying thoughts about the governance, independence and structure of the agency.
For one, current legislation supporting ARPA-H looks to nest it within NIH as an independent agency. While some panelists supported this decision, others said that given the separate natures of NIH and ARPA-H, independence would be muddled.
“I believe that it would be a fatal mistake to organize ARPA-H within the NIH,” Former Assistant Secretary for Health Adm. Brett Giroir said. “To a great degree, we need ARPA-H because the NIH cannot maintain a culture of radical innovation, disciplined execution, specific accountability and streamlined processes that are essential for ARPA-H. Don’t misunderstand me — the NIH is outstanding at what it does, but it will never be DARPA or ARPA-H.”
Dr. Keith Yamamoto, University of California San Francisco’s science policy and strategy vice chancellor, agreed, adding that NIH must continue to thrive for ARPA-H to succeed. He called on Congress to establish safeguards to prevent ARPA-H funding from supplanting NIH investments or threatening its culture.
“An organization like ARPA-H exists to challenge conventional wisdom,” Yamamoto said. “Don’t put it inside the very organization that holds the conventional wisdom.”
On the other hand, Milken Institute's FasterCures and Center for Public Health Executive Director Dr. Esther Krofah argued that NIH and ARPA-H could co-exist well seeing as how the Department of Energy maintains its own advanced research agency, ARPA-e.
“We do not see a reason ARPA-H could not be situated within NIH and still accomplish its mission, including advantages to having easy access to other NIH infrastructure, personnel, programs and expertise,” Krofah said.
Beyond the considerations in where to house ARPA-H, the panelists offered other thoughts on how the new agency should be established. Several witnesses argued that ARPA-H program managers should have diverse backgrounds and work shorter tenures, as well as establish streamlined, rapid award processes, just as DARPA does. Giroir added that ARPA-H should also maintain a peer review process that resembles DARPA’s rather than NIH’s.
On Demand Pharmaceuticals CEO and Johns Hopkins Medicine Neurology Professor Dr. Geoggrey Shiu Fei Ling — who also founded DARPA’s Biological Technologies Office — argued that Congress needs to structure ARPA-H so that it has “end-to-end” processes, from exploring and conducting the science, to regulating, and then distributing and understanding patient feedback.
To build an end-to-end model in ARPA-H’s programs, Krofah added that it will be critical for the agency to collaborate with other agencies health agencies.
“FDA is obviously a critical link the process that gets exciting new science and products into the hands of patients,” Krofah said. “We need to make sure they have the resources and expertise to keep pace and effectively regulate new technologies coming to them for review, through efforts like ARPA-H. There also needs to be active and regular engagement with other agencies critical to advancing solutions to patients, such as CMS and CDC.”
Krofah also said that ARPA-H should develop data-driven and transparent processes to establish its priorities and should invest in platform technologies and infrastructure in preparing its formation. She also emphasized that personnel and leadership at ARPA-H should offer diverse backgrounds and expertise to help build equity in health innovations.
While all of the panelists supported ARPA-H overall, Johns Hopkins Medicine Professor Dr. Brian Miller said that ARPA-H isn’t enough to keep up with adversarial advancements in research and development, such as those happening in China.
“The biopharmaceutical company market cap of Chinese companies rose from 3 billion to 380 billion — a 100-fold increase over the last five years,” Miller said. “There were 23 Chinese life science IPOs in 2020. Of the world’s largest bioscience IPOs, seven out of 10 were from China. China has more researchers than we do and more patents granted. … So ARPA-H is really not enough if we’re going to respond to China. We need to protect our greatest achievement, which is our biomedical research industrial complex.”
Amid the panel’s input for lawmakers to consider in standing up ARPA-H, lawmakers have introduced legislation that would fund the new agency at $3 billion in the House and $2.4 billion in the Senate. The next steps in ARPA-H’s funding are contingent on the subcommittee writing and passing authorizing legislation, Committee Chair Rep. Frank Pallone said.