Biden’s new biomedical agency fails to gain independence from NIH

It’s decided. President Joe Biden’s new biomedical research agency for high-risk, cutting-edge research won’t have the full autonomy many backers had sought. Instead, it will sit within the National Institutes of Health (NIH). But to give the agency a measure of independence, its director will report to the NIH director’s boss, the secretary of health and human services (HHS).

That is the compromise reached by HHS Secretary Xavier Becerra, he told Congress yesterday in a letter explaining the structure of the new Advanced Research Projects Agency for Health (ARPA-H). HHS declined to share the letter, but an agency spokesperson said in a statement that although ARPA-H will be “a new member of the HHS family with a distinct mission,” it won’t be a stand-alone agency. Instead, “Authority for administration and operation of ARPA-H will reside with a Director who will report directly to the Secretary of HHS under the auspices of the National Institutes of Health.”

Today at a hearing held by the House of Representatives appropriations subcommittee that oversees the HHS budget, Becerra explained that by placing the director “under my supervision … what we’re hoping to do is show that there will be autonomy.” NIH’s role, he said, will be to provide “the administrative work,” such as human resources, payroll, and legal services, to stand up the agency.

Although part of NIH, he added, ARPA-H will be “physically … separate,” as some advocates have recommended. It will be staffed by “a very lean and nimble team” of a director and program managers who will likely hold their job for no more than 3 to 5 years. “We need to make sure it’s not anchored or tethered to doing things an older way,” Becerra said.

The decision about ARPA-H’s home settles, at least for now, a debate that began 1 year ago, when Biden proposed a new, nimble agency for funding bold biomedical research ideas modeled after the Defense Advanced Research Projects Agency. Many supporters of ARPA-H argued it needed to be an independent agency to break with NIH’s slow, conservative grantmaking culture.

Biden administration science officials countered that placing it at NIH would provide the infrastructure needed to quickly start hiring and awarding contracts and allow the agency to draw on NIH’s scientific expertise.

This year’s omnibus spending bill Congress approved 2 weeks ago created ARPA-H as a stand-alone agency within HHS with a $1 billion starting budget. But it included a provision that allowed the HHS secretary to move it to an HHS component such as NIH within 30 days. Becerra was obligated to inform Congress of his plans within 15 days, making yesterday the deadline.

In recent days, some advocacy groups have agreed that although placing ARPA-H at NIH was not ideal, it would be a more efficient way to launch it. But at today’s hearing, the subcommittee’s leaders—Rosa DeLauro (D–CT) and ranking member Tom Cole (R–OK)—emphasized they would still prefer ARPA-H to be independent. It “would be more successful in its unique mission,” DeLauro said.

Becerra’s decision may not be the last word. A bill in the Senate would make ARPA-H part of NIH but put into law the requirement that its physical location be far from the agency’s campus in Bethesda, Maryland, and impose other requirements to ensure its independence. A House proposal, meanwhile, would make it an independent agency. That bill’s sponsor, Anna Eshoo (D–CA), commented in a statement that the “decision to place ARPA-H in the organizational chart of NIH is an opportunity squandered.”

Some lawmakers are also concerned that the president’s 2023 budget proposal favors ARPA-H while shortchanging NIH’s 27 other institutes and centers. It gives $4 billion of a $4.3 billion proposed NIH increase to ARPA-H, leaving just a 0.6% increase for NIH’s base budget.

“I think it’s a mistake to shift funding away from basic biomedical research into a brand-new program in 1 year” for an agency “that will take time to get up and running,” Cole said.