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New Biomedical Incubator Beloved on Hill Stalled in Budget Fight

Oct. 7, 2021, 9:35 AM

President Joe Biden‘s plan to set up an NIH incubator for biomedical discoveries could face setbacks as the government runs on a continuing resolution through early December.

The administration is still moving forward with plans to open the Advanced Research Projects Agency for Health in the coming months, the White House’s point person on the project said.

“We’re continuing our planning and engagement efforts that we’ve been launching. And we’ll continue to do so, and we’re optimistic, obviously, about getting something in [fiscal year] ’22,” Tara Schwetz, assistant director for biomedical science at the White House Office of Science and Technology Policy, said in an interview.

But the continuing resolution that averted a government shutdown through Dec. 3 means agencies like the National Institutes of Health can’t start new programs. The administration unveiled the ARPA-H plan this spring as part of its fiscal 2022 budget proposal.

The concept has bipartisan support on Capitol Hill, and any seed funding to get the agency up and running will likely survive moves to trim the administration’s $3.5 trillion domestic spending agenda as lawmakers focus on big-ticket items such as adding new benefits to Medicare or expanding Medicaid in Republican-controlled states.

“While we’re glad that Congress was able to keep the government open,” Tannaz Rasouli, executive director of the Ad Hoc Group for Medical Research, said, “in general, CRs are disruptive and delay decision-making on major new initiatives.”

To the extent that Congress opts to fund ARPA-H through the annual appropriations process, funding for the initiative won’t become real until the spending bill for the NIH is finalized, Rasouli said.

“We know that being in ‘budget limbo’ is not ideal for planning in science—NIH has unfortunately had a lot of practice in successfully navigating that uncertainty over the years, but without question, when Congress completes the spending bills in a timely manner, it allows for far greater efficiencies and opportunities,” Rasouli said.

ARPA-H Money

Modeled after existing programs in the departments of Defense and Energy, ARPA-H would be housed in the NIH and aims to bring game-changing discoveries to patients in record time through new public-private partnerships for short-term, riskier projects. The goal is to cut in half the time it would take to develop medical advances, such as a single shot to protect against the top 10 infectious diseases or an mRNA vaccine to shield against common cancers.

Both the president’s budget proposal and the House’s FY 2022 spending bill for Labor, Health and Human Services, and Education and Related Agencies included money for ARPA-H. But the Build Back Better Act also includes $3 billion in FY 2022 through the reconciliation process to establish ARPA-H, and the lawmakers behind forthcoming follow-up legislation to the 2016 law 21st Century Cures said they will include language to authorize ARPA-H in their bill.

“If that provision makes it through the end of the reconciliation process, it could provide a little bit of a head start for ARPA-H before the FY ’22 spending bills are finalized,” Rasouli, who’s also the senior director of public policy and strategic outreach at the Association of American Medical Colleges, said.

Whether it’s funded through FY 2022 appropriations or reconciliation or both, Rasouli said she wouldn’t be surprised if there’s also legislation to establish any authorities that ARPA-H might have once it’s funded. “That wouldn’t necessarily be tied to the continuing resolution,” she said.

“In any case, we know that the administration has been giving a lot of thought to the idea, so they’re doing what they can in the meantime,” Rasouli said.

Indeed, Schwetz said OSTP is continuing to solicit feedback from the research community about ARPA-H, to identify the biggest challenges facing the biomedical and health communities.

“What are those sort of crazy `if we could only do X, Y would happen’ and it would have a large impact?” she asked. “Those are the kinds of things that we’re working with the community to get. We’re continuing those efforts.”

Seeking Ideas

If Congress authorizes and provides funding for ARPA-H, Schwetz said the first steps will be getting people on board to help build the organization, including program managers to oversee projects. They’ll also want to move quickly to put out some sort of solicitation for research ideas.

“We have been saying that likely for this first year, at least, we would put out just sort of a broad announcement that kind of says give us your biggest, boldest ideas, much akin to what ARPA-H has done, and we’re going to try to make awards for fiscal year ’22. That’s our goal,” Schwetz said. “Of course, as things evolve, we’ll evolve our goals.”

NIH Director Francis S. Collins said at the virtual Rally for Medical Research on Sept. 22 that he’s “hoping that we can see this also get launched in the course of the next few months,” outlining an ambitious plan to get the new research entity off the ground.

While Schwetz didn’t hear the original comment, she said, “We’re still within that window.”

“I mean, we’re only talking about two months right now,” she said about the Dec. 3 expiration date on the continuing resolution “We’re continuing our planning efforts. There’s a lot to go into thinking about what needs to happen to set up a new entity.”

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloombergindustry.com

To contact the editors responsible for this story: Alexis Kramer at akramer@bloomberglaw.com; Karl Hardy at khardy@bloomberglaw.com

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