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Health research focus could give NIH competition for funding

Full article available on Roll Call.

Lawmakers are more interested in biomedical research than ever, but with limited funds for nondefense spending, experts worry the National Institutes of Health could end up in competition with the new agency the Biden administration wants to build to confront the toughest problems.

The administration’s vision for a big and bold disease-curing agency — the Advanced Research Projects Agency for Health, known as ARPA-H — is finally coming to fruition at the same time President Joe Biden has relaunched the Cancer Moonshot, which has the goal of slashing the cancer death rate by at least 50 percent over the next 25 years.

Usually, this interest in medical research would be great news for the NIH as the appropriations season begins. But both projects require big financial outlays at a time the Republican-led House is demanding spending cuts in exchange for approval of an increase in the debt limit.

The White House has proposed relatively flat funding for the NIH and is seeking a $1 billion increase for the NIH’s newer, flashier cousin, ARPA-H.

Biden’s budget asks for $2.5 billion for ARPA-H for fiscal 2024, a $1 billion, or 66 percent, increase from funding for the current year. The budget request also includes $46.4 billion in discretionary spending for the NIH, compared with $46.1 billion enacted. That’s an increase of  less than 0.1 percent.

Requesting a huge percentage increase for ARPA-H while holding the rest of NIH almost flat could set the two agencies up as rivals, said Erik Fatemi, a former staff director of the Senate Labor-HHS-Education Appropriations Subcommittee who handled NIH appropriations. He is currently a principal at Cornerstone Government Affairs.

Even Health and Human Services Secretary Xavier Becerra is mindful he may have to play peacemaker between the two agencies, according to comments he made at an HHS event commemorating the first anniversary of the launch of ARPA-H.

When asked what his first thoughts on ARPA-H were, Becerra said his original concern about the new agency’s creation was, “Is NIH going to be OK with this?”

Becerra added, “I just want to stay out of the way. I want NIH to be happy as well.”

GOP demands

Over the past eight years, the NIH has received a 57 percent funding increase even as control of the House and White House seesawed. But there’s a long history of presidents lowballing requests for NIH anticipating that Congress would increase the final appropriation.

This year’s budget climate is very different. Speaker Kevin McCarthy, R-Calif., promised holdouts during his bid for the gavel that the chamber would write its appropriations bills at the fiscal 2022 topline level, which would be more than $130 billion below the level enacted for the current fiscal year. Reductions to nondefense programs could top 22 percent.

This could mean the NIH would make 5,000 fewer grants, Becerra told House Appropriations ranking member Rosa DeLauro, D-Conn., in a letter.

Meanwhile, one of the NIH’s biggest Republican champions in the Senate, Missouri’s Roy Blunt, has retired. And Oklahoma Rep. Tom Cole, who backed the agency as the top Republican on the Labor-HHS-Education Appropriations Subcommittee, is now leading the panel controlling transportation and housing funding.

Cole is still on the full Appropriations Committee, however, and is hopeful Congress will increase NIH funding this year. He blamed Democrats for overspending and putting Republicans in a difficult position when it comes to budget cuts.

“Personally, I would hope the NIH can continue to do well. I think it’s very important to the country long term and very important to American people in the short term,” he said.

“I’m not going to be in the business of second-guessing what the new chairman there has to do,” he added, referring to Alabama Republican Robert B. Aderholt. “I suspect there’ll be a lot of tough calls for him.”

Aderholt did not respond to requests for comment.

The top Republican on the Senate Appropriations Committee, Susan Collins of Maine, was more optimistic.

“There is simply no investment that promises greater returns for America than our investment in biomedical research,” Collins said in an email. “I expect Congress to continue to prioritize these important investments in FY2024.”

Senators are currently focusing on topline numbers that each Appropriations subcommittee will get to spend. Labor-HHS-Education Subcommittee member Jack Reed, D-R.I., said they are rushing to get their nondefense spending toplines out as soon as possible in hopes the House will follow suit.

But there’s no real timeline for when the Senate will release the toplines, and the White House and McCarthy do not appear to be getting any closer to a deal on the debt limit.

“​​If Republicans were successful in slashing nondefense as much as they wanted to, there’s no way that NIH could escape,” Fatemi said.

Similar agencies, different roles

A big funding push for ARPA-H could become a replacement for other biomedical research funding asks, some worry.

“Oftentimes, supporting government funding like ARPA-H or NIH becomes the fodder for members on the Hill to say, ‘I’m pro-innovation, I support increased funding here, so all our problems are solved,’ but that’s a very small piece of the innovation ecosystem,” said Nick Shipley, chief advocacy officer at the Biotechnology Innovation Organization.

Ellie Dehoney, a senior vice president at the academic research advocacy group Research!America, also worries about the overlap between the two agencies.

“One of my concerns is that NIH will essentially partner with ARPA-H and put in funds into joint projects when actually ARPA-H is supposed to have a budget to cover unique projects. So if NIH plays a role, their function bleeds in,” Dehoney said.

ARPA-H has caught the attention of Capitol Hill, but much of the new agency’s mission remains undefined.

So far, it has only hired two project managers and announced its basic structure. No decisions about projects or where it will be headquartered have been announced. Its charter says ARPA-H will have a small staff of just 210 people, and much of its mission will be defined by the grants it gives out.

Modeled after the Pentagon’s Defense Advanced Research Projects Agency, it aims to make big breakthroughs in cancer research, Alzheimer’s and other chronic diseases.

The current biomedical research system is largely driven by NIH-supported research, universities and the drug industry. The Biden administration argues this framework makes it difficult to take on ideas that could yield bold breakthroughs — because they are too expensive, would take too long or run the risk of failing.

ARPA-H would fill that gap by conducting the sort of high-risk research that’s just so crazy it might just work.

“We are part of this ecosystem, and we’re here to catalyze it. We’re here to add a little bit of rocket fuel to it,” ARPA-H Director Renee Wegrzyn said earlier this month at HHS headquarters.

There are some areas where the NIH and ARPA-H will overlap — the most obvious being cancer research. The NIH’s National Cancer Institute has been working for nearly 90 years running clinical trials on new cancer therapies and has been charged with leading research on Biden’s Cancer Moonshot. But when people talk about the aims of ARPA-H, curing cancer often comes up first.

A National Cancer Institute spokesperson described ARPA-H and NCI as “complementary,” with NCI providing input and technical expertise to help the new agency find project managers. Wegrzyn has said that ARPA-H will not have offices dedicated to the Cancer Moonshot, but the new agency’s work could support moonshot goals. In short, both agencies will need money to help reach the White House’s goals.

“Once we start playing this game where it’s either ARPA-H or NIH, then we play into a really counterproductive formula for medical progress. Both are needed,” Dehoney said.

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