Defying Biden, Congress Moves to Give the New Health Research Agency More Independence
Lawmakers want to shake up the agency just months after it was created.
A newly stood up agency that Congress has provided with $1 billion for conducting “high-risk, high-reward” health research could soon see its structure shaken up just months after lawmakers authorized it, even as the White House has expressed reservations about the change.
The House this week is planning to vote on the Advanced Research Project Agency-Health (ARPA-H) Act (H.R. 5585), which would move the new agency outside its current home within the National Institutes of Health to be its own entity within the Health and Human Services Department. Congress formally approved and funded ARPA-H in the fiscal 2022 omnibus funding bill, which left it up to the Biden administration to determine the agency’s structure. With some controversy, the administration determined it should be a component of NIH in order to leverage that research agency’s experience and services.
The agency will focus on developing scientific breakthroughs on diseases such as ALS, Alzheimer’s Disease, diabetes and cancer. Its scientific, engineering, medical and professional will fall outside of normal civil service laws, with its presidentially appointed director having free rein to hire and fire them. The ARPA-H Act would codify that carve-out and allow the agency’s director to set up a unique pay scale, while also enabling the director to hire support staff under normal procedures.
The bill would allow for a variety of avenues to fund research projects, including grants, contracts and prize competitions. The measure would prohibit anyone in the administration from directing any ARPA-H employee from making specific recommendations or testimony, including if those views did not align with the president’s. In a statement on Tuesday, the White House took issue with that provision. ARPA-H should not be able to bypass the process for ensuring its communications with Congress are "accurate and reflect the views of the executive branch," the White House said.
Overall, the administration said it supported the bill and urged its passage. It objected to a key provision, however, saying leveraging NIH’s “existing infrastructure would provide for the most efficient administration of the program’s goals.” HHS Secretary Xavier Becerra announced last month he would establish ARPA-H within NIH, though its director would report to him directly. At a hearing just before that announcement, Becerra told lawmakers ARPA-H would be "more nimble, more facile and be able to break away from the tethers of governance" at NIH while also benefiting from "the efficiencies that NIH has" such as its payroll, accounting, human resources and other services.
Lawmakers of both parties and stakeholders have questioned that decision, saying NIH has an inherently different mission than ARPA-H. They also expressed concern the new agency would bleed funds from its existing partners. Under the ARPA-H Act, the agency would have a separate budget from HHS.
Rep. Anna Eshoo, D-Calif., who introduced the bill, said there is a large gap between the risks NIH is willing to take in research and what the private sector sees as a sufficient return in funding. ARPA-H will bridge that gap, she said, if it is afforded the independence it requires to ensure “breakthrough discoveries can be realized on the deadliest diseases we face.”
The agency will 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, noting one key distinction for the agency.
Geoffrey Ling, a former Army colonel who first proposed ARPA-H in a 2019 white paper, said at the hearing that establishing the agency’s independence was the most important step to ensuring its success. He added the success of his former employer—the Pentagon’s equivalent of ARPA-H, the Defense Advanced Research Projects Agency—was driven by its separation from existing research entities within the Defense Department.
“Nothing is more critical to the success of this new agency than getting it right from Day 1, starting with the leadership, authorities, resources, culture, and independence,” Ling said. “Retrofitting an existing agency within the government to include ARPA-H will send a message that this approach is merely more of the same, with a different name and some new funding.”
Frequent turnover of senior staff would ensure “fresh ideas and perspectives are always flowing” at the agency, he added, and the unique culture of urgency and problem-solving would make it ill-fitted for NIH.
Brett Giroir, former assistant secretary for health at HHS, said it would be a “fatal mistake” to put ARPA-H within NIH. The latter agency is intentionally not designed to and is not capable of creating a culture of innovation like exists at DARPA.
“This is not to say that the NIH is not outstanding and necessary for what it does—it is,” Giroir said. “But the NIH will never be DARPA or ARPA-H.”
The ARPA-H Act has bipartisan support and is expected to pass the House this week. It is unclear if the bill can pass the Senate, as a bipartisan bill introduced by leaders of the Senate Health, Education, Labor, and Pensions Committee would maintain ARPA-H’s current structure within NIH.