HEALTH CARE BRIEFING: NIH Chief Touts Biden Research Agency Plan

By Brandon Lee and Alex Ruoff

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The National Institutes of Health’s emerging technologies agency proposed by the Biden White House won’t detract from the rest of the agency’s $43 billion research portfolio, but it may fold in some existing programs.

House Appropriations Chair Rosa DeLauro (D-Conn.), whose spending panel has to sign off on President Joe Biden‘s request for a $6.5 billion agency called the Advanced Research Projects Agency for Health, said yesterday she was “intrigued,” but emphasized the rest of the NIH—and 300,000 scientists who rely on its grants—can’t suffer as a result.

DeLauro further asked about how ARPA-H would differ from the National Center for Advancing Translational Sciences in identifying any bottlenecks and speeding discoveries into patient care.

“This basically takes the NCATS model and puts it on steroids,” Director Francis S. Collins said before the House Appropriations Labor, Health and Human Services, Education, and Related Agencies subcommittee during a hearing on NIH funding. The new agency at NIH “will catalyze novel strategies to speed transformational, innovative ideas,” he said.

Details on the agency are still slim until the full budget comes out this Friday. But Biden released a skinny budget request in April that included a $9 billion increase for the NIH, $6.5 billion of which would go toward ARPA-H. The proposal builds on the momentum of the pandemic response to bring about Covid-19 vaccines in less than a year, which resulted from public-private partnerships and billions of federal dollars to buy vaccines at risk before Food and Drug Administration authorization.

“We’ve learned a lot in the space of our experience with Covid-19, how it’s possible when there’s an urgent sense of the need for clinical advances to happen,” Collins said. “From that we’ve gathered the general sense that this momentum ought not to be lost.”

ARPA-H would pay for ideas like “simple blood tests to detect free floating DNA or protein markers that signal a cancer is growing somewhere” or a patch capable of delivering vaccines in the mail to hard-to-reach communities. “They’re not science fiction,” Collins said. Under standard approaches, those ideas could take a decade or two to become a reality but ARPA-H could do it in half the time, he said. Jeannie Baumann has more.

  • Meanwhile, Rep. Tom Cole (R-Okla.), the top Republican on the House Appropriations Labor-HHS-Education Subcommittee, says he supports Biden’s requested top-line funding figures for the NIH, Centers for Disease Control and Prevention, and the Strategic National Stockpile. Biden in his skinny budget requested $51 billion for NIH in fiscal 2022, a $9 billion increase over fiscal 2021; $8.7 billion for the CDC, a $1.6 billion increase; and $905 million for the Strategic National Stockpile, a $200 million increase over the amount in the fiscal 2021 omnibus spending bill, Jack Fitzpatrick reports.

Happening on the Hill

Hearings on the Hill:

  • Vaccine Confidence: The House Energy and Commerce Oversight and Investigations Subcommittee scheduled a hearing on building Covid-19 vaccine confidence.
  • CDC Appropriations: The House Appropriations Labor-HHS-Education panel will weigh appropriations for the Centers for Disease Control and Prevention.
  • NIH Appropriations: The Senate Appropriations Labor-HHS-Education panel will consider appropriations for the National Institutes of Health and medical research. NIH Director Francis S. Collins and National Institute of Allergy and Infectious Diseases Director Anthony Fauci will testify.

Senate Agrees to Research Funding Ban in China Competition Bill: The Senate yesterday agreed to an amendment to ban federal funds for certain virus research in China as part of legislation to increase the U.S.’s competitive edge with the country (S. 1260). Some studies of viruses, known as ‘gain-of-function’ research, alter the organisms’ functions and have the potential to enhance a virus’s transmissibility. This has prompted the U.S. to adopt safety guidelines for overseeing such work. Sen. Rand Paul (R-Ky.), the sponsor of the amendment, raised the concern that the novel coronavirus might’ve been created by such research. There is no evidence the virus was created in a lab in China, although public health authorities have sought a full investigation into its origin. NIH later issued a statement saying the agency has not directly funded gain of function research, Alex Ruoff and Jeannie Baumann report.

  • The chamber also agreed to an amendment by Sen. Joni Ernst (R-Iowa) to prohibit any federal funding for China’s Wuhan Institute of Virology.

Senate Panel to Shift to Pre-Pandemic Hearing Rules: Senate committees plan to roll back some of their virus protocols after the Memorial Day recess, meaning senators and witnesses will again appear in-person at hearings and non-masked. “I expect, following this break, our hearings will look and operate more closely to how they did before the pandemic,” said Health, Education, Labor, and Pensions Chairwoman Patty Murray (D-Wash.). Read more from Alex Ruoff.

Murray Pushes Maternal Health Bills: Also yesterday, Murray pledged to get a series of maternal health measures signed into law and fully funded. The Health, Education, Labor and Pensions Committee yesterday unanimously advanced six bipartisan bills, including two (S. 1675, S.1491), to establish programs aimed at improving maternal health and fighting racial biases. “I’ll be pushing to not only get these bills passed into law as soon as possible, but also to follow up on them, fund them, and build on them,” she said.

The committee also approved a bill (S. 610) to establish grants for training doctors in strategies to tackle mental health and substance use disorders, aimed at reducing suicide deaths among health-care providers, Alex Ruoff reports.

ACA Veteran Wins Nod as Medicare, Medicaid Chief: Biden’s pick to lead further expansion of the Affordable Care Act and Medicaid—Chiquita Brooks-LaSure—won Senate confirmation yesterday by a 55-44 vote. Brooks-LaSure’s confirmation to be Centers for Medicare and Medicaid Services administrator entrusts her with one of Biden’s main health policy priorities: strengthening and building upon Democrats’ signature health law. Read more from Shira Stein.

The Coronavirus Pandemic

Moderna Shot Highly Effective in Teens: Moderna’s Covid-19 vaccine was highly effective in 12 to 17 year-old adolescents in a large-scale study, paving the way for regulatory submissions worldwide by early June. In a release, the company said its vaccine was between 93% and 100% effective in preventing symptomatic Covid-19 in a study of teenagers, depending on whether very mild cases are included in the count. Read more from Robert Langreth.

Air Passengers Warned to Wear Masks: U.S. government officials monitoring the airways say they won’t tolerate passengers refusing to wear masks as airline travel surges ahead of the summer season. A recent bump in misbehaving air passenger reports, many of them involving those refusing to cover their faces, has prompted Homeland Security Secretary Alejandro Mayorkas to issue his warning to travelers yesterday. Read more from Alan Levin.

Providers Testing Uninsured People Get $4.8 Billion: Community health centers and other service providers will get $4.8 billion to test uninsured people for Covid-19, the Department of Health and Human Services announced. Roughly 29 million people in the U.S. are uninsured, the HHS said. Community health centers provide primary care for more than 30 million people per year, 63% of whom are people of color, federal data show. Read more from Shira Stein.

More U.S. Headlines:

More Global Headlines:

What Else to Know

Medical Care for Transgender Youth Stirs Federal-State Clash:Action by the Biden administration to protect LGBT individuals from discrimination in health care pits the federal government against states passing laws that prohibit gender-affirming care, such as puberty blockers, for transgender minors. Arkansas and Tennessee have recently passed such laws. Meanwhile, the Department of Health and Human Services said it would resumeenforcing protections for LGBT Americans in health care, reversing a ban put in place by the Trump administration. This puts the states’ laws in direct conflict with federal law, attorneys say.

Transgender youth “are already at significant risk of bullying and harassment. And these state laws limiting their participation in sports and especially the laws that are limiting their access to medical care are just so difficult,” Rachel Levine, assistant secretary for health at the HHS, said in an interview. Read more from Shira Stein.

Trump HHS Counsel Returns to Greenberg Traurig: Robert Charrow, the former general counsel at the Health and Human Services Department during the Trump administration, has rejoined Greenberg Traurig, a spokesperson told Bloomberg Law. Charrow oversaw more than 600 attorneys at the HHS and led the agency in its legal response to the Covid-19 pandemic, drug pricing, the Affordable Care Act, and Medicare reimbursement. Read more from Shira Stein.

More Headlines:

From the Courts:

With assistance from Alex Ruoff, Jack Fitzpatrick, and Jeannie Baumann

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com

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