Biden wants $6.5 billion for new health agency to speed treatments

Biden wants $6.5 billion for new health agency to speed treatments
The Biden administration today began to flesh out a proposal for a new agencymodeled on the militarys Defense Advanced Research Projects Agency (DARPA)that would seek to speed the development of medical treatments by funding risky, innovative projects. The agency, dubbed ARPA-Health (ARPA-H), would be housed at the National Institutes of Health and have a 2022 budget of $6.5 billion, according to a White House spending request released today .

Few other details about ARPA-H have been released, except that it would initially focus on cancer and diseases such as diabetes and Alzheimers. Advocates who have been pushing for the new agency welcomed the announcement, but some were dismayed that ARPA-H will not be a stand-alone agency within the Department of Health and Human Services. If its just another fund within the NIH, were not optimistic that its going to succeed, says Liz Feld, president of the Suzanne Wright Foundation, a pancreatic cancer research advocacy group.

Feld is part of a group of disease advocates and former U.S. officials who have been pushing for ARPA-H since 2017, when they . They argue that too much NIH-funded research does not make it out of the lab because of a lack of funding for the high-risk work needed to develop a treatment to the point where it interests companies.

Under the DARPA model, projects would not be vetted by peer reviewers, but instead, funding decisions would be made by program managers. And instead of multiyear grants, the agency would disburse awards as milestone-driven payments; program managers could also cancel projects that they decide arent panning out.

The idea found a warm reception from Biden, who became a champion of cancer research after his son Beau Biden died from brain cancer in 2015. On the campaign trail, Joe Biden talked of launching a massive health agency following the DARPA model. In February, soon after his inauguration, he brought up the ARPA-H proposal on a visit to a COVID-19 vaccine manufacturing site where he vowed to end cancer as we know it.

Last month, Biden met to discuss ARPA-H with lawmakers including architects of the 21st Century Cures law that funded the Cancer Moonshot, which Biden created as vice president during the Obama administration.

What hadnt been clear until today, however, is the proposed funding level. The $6.5 billion included in todays request to Congress far exceeds what some expected, at least in the first year. (The money is part of an overall request for a $9 billion increase in NIHs budget, to $51 billion.) Some observers are also surprised by where Biden wants to put the new agency within the federal government. The White House might see locating ARPA-H at NIH as the fastest way to launch it because the move doesnt require new legislation in Congress, advocates say. But some worry ARPA-H will lack the structure and independence it needs.

It has tremendous potential at NIH, says geneticist Michael Stebbins, a consultant and former White House science office official. But it has to be based on contracts, the program directors have to have tremendous flexibility, and the ARPA-H director has to have the authority to make decisions. Otherwise, youre just increasing the NIH budget. Feld is less optimistic: This is about a whole culture and operating structure that doesn t exist within the NIH, she says.

One rumor is that ARPA-H will be part of the Common Fund, a central fund under the direction of NIH Director Francis Collins. But Stebbins argues that it should not be an extension of the Common Fund. It needs to function in a very different way.

Whatever the structure, one academic researcher familiar with both DARPA and ARPA-H sees the proposal as positive for the biomedical research community. NIH peer reviewers tend to be pretty conservative. Leaving decisions to informed program managers will diversify the portfolio of health sciences research, says Harvard University chemical biologist David Walt, a former chair of DARPAs advisory council.

Walt cautions, though, that supporters need to temper their expectations because any new medical treatments that come out of ARPA-H will still need to go through the long slog of clinical testing and regulatory approvals. Its not like at [the Department of Defense], where you can invent a land mine detector and use it in the field 2 weeks later.

Meanwhile, biomedical research advocates are worried the new agency will cut into base budgets for NIHs 27 institutes and centers. We do not believe it is in the nations interest to channel funding away from other research priorities under the institutes purview, ResearchAmerica said. The group is urging a 10% increase to NIHs base budget, which under the Biden proposal appears to get a smaller raise. Congress will have the final say on the overall numbers.

ARPA-H is just one of a number of efforts in recent years to emulate DARPA. Past administrations have created ARPAs at the departments of Energy and Homeland Security, as well as for the intelligence community. And, in addition to ARPA-H, Biden today proposed creating an ARPA-Climate that would focus on developing technologies to combat global warming.
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