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Bill to Create Biden’s Biomedical Agency Wins House Passage

June 22, 2022, 10:45 PM

House passage of legislation to shepherd biomedical breakthroughs through a new agency marks a critical step in shaping how the government entity will direct billions in health spending.

The bill (H.R. 5585), which the House passed Wednesday on a 336-85 vote, would establish the Advanced Research Projects Agency for Health—modeled after a Pentagon entity for developing national security technologies. ARPA-H would fund applied research with short-term teams to solve major challenges, such as a vaccine to prevent most cancers.

Rep. Anna G. Eshoo, the bill’s lead sponsor and chair of the Energy and Commerce health panel, described ARPA-H as a small, independent agency “with a mission that can be transformational” by pursuing research that’s too risky for the private sector and also falls outside of the National Institutes of Health’s mission to seek fundamental knowledge.

“Every single one of us knows—from our families, from our extended families, in our community—of individuals that have received a diagnosis that’s a death sentence. And we don’t have an effort that is singularly designed to pursue that,” Eshoo said in an interview Wednesday before the vote. “If one deadly disease were conquered, this effort would be worth it.

The White House on Tuesday issued a statement that strongly supports the bill while expressing reservations about certain provisions.

Plans to set up ARPA-H are already underway at the Department of Health and Human Services and the National Institutes of Health. Congress gave the Biden administration $1 billion in its 2022 spending plans to get the entity off the ground.

H.R. 5585 would give Congress more power to oversee the new agency’s structure, which is still in the early stages of development. The Biden administration proposed a $4 billion increase for ARPA-H in fiscal 2023, although congressional appropriators have expressed concern about a plan that pours billions into the new agency while leaving about a $270 million increase for the NIH over 2022.

The latest House bill would cap ARPA-H’s administrative costs to 15% of its funding, limit the number of program offices it can have, and require that at least two-thirds of those offices “be exclusively dedicated to research and development.” The bill would prohibit funding projects in Russia, China, North Korea, and Iran, or any other covered foreign entity under the National Security Act.

“Oversight, obviously, is going to be very important, but the authorities that are spelled out in the legislation are our real roadmap for success,” Eshoo said. “The specificity matters. If you list out 22 programs, it’s not designed to carry that kind of capacity. There’s a cap on administrative costs because you don’t want that part of it to grow. You want the investment to be on the very mission of the agency. So I think that we have shaped it well.”

Conservative group Freedom Works expressed opposition to ARPA-H in a tweet ahead of the vote, calling it “ANOTHER federal agency within the public health bureaucratic apparatus that Americans have grown weary of over the past several years.”

Working Out Differences

The bill has bipartisan support in the committee that authorized it, which approved the bill 53-3 last week. The House Rules Committee hearing Tuesday included joint testimony from Eshoo and Rep. Brett Guthrie (R-Ky.), ranking member of the Energy and Commerce health subcommittee.

However, the bill still faces several hurdles as lawmakers work to iron out differences with the Senate and what the White House envisions for the new agency.

Republicans and Democrats, including appropriators and House Energy and Commerce Committee members, balked at the HHS announcement this spring to establish ARPA-H within the NIH, although the HHS said it would still be independent. At issue is whether ARPA-H’s culture will be distinct enough to fill the gap between discovery and commercialization if it’s still part of NIH.

The House bill would place ARPA-H outside of the NIH but within the health department.

The White House says the NIH’s existing infrastructure will allow ARPA-H to be stood up in “a timely and efficient manner.”

The administration “supports an approach that provides the agency with flexibility to adapt to unforeseen circumstances and believes that leveraging the National Institutes of Health’s existing infrastructure would provide for the most efficient administration of the program’s goals,” it said in the statement.

Eshoo said the most important part the White House statement was that it urged “the entire House of Representatives to vote for it.”

The Senate Health Education Labor and Pensions Committee approved its own ARPA-H bill in March as part of a larger bipartisan pandemic preparedness package (S. 3799). That bill would establish ARPA-H as part of the NIH.

House and Senate staff have been in discussions about the different ARPA-H bills and will continue to do so, Eshoo said. “I don’t view the differences as trying to scale Mount Everest. It can be done,” she said. “The effort itself is worth it.”

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

To contact the editor responsible for this story: Alexis Kramer at akramer@bloomberglaw.com