The March 4 congressional hearing on the budget for the NIH was peppered with questions about the COVID-19 outbreak, although the general sentiment is that the agency will receive yet another boost in appropriations in fiscal 2021. The subcommittee chairwoman, Rep. Rosa DeLauro (D-Conn.), said late in the hearing that an agreement has been reached between House and Senate leaders on a supplemental spending bill for the COVID-19 outbreak, suggesting that the federal government response to the pathogen is about to take on new urgency.

The NIH budget has enjoyed increases of roughly $2 billion in each of the past five fiscal cycles, a trend that seems likely to sustain. The March 4 hearing for the House Appropriations subcommittee for labor, HHS and related agencies affirmed that approach, with subcommittee ranking member Tom Cole (R-Okla.) remarking, “this is going to be a very tough year” for budgeting.

Cole noted that the 2018 budget agreement between the Trump administration and Congress calls for flat-funding across the entire federal government, but that Congress will have to rob Peter to pay Paul in some instances. “Fortunately, you’re Paul, and someone else has to be Peter,” Cole said to the NIH managers in attendance. Panel chairwoman Rosa DeLauro (D-Conn.) affirmed that view, stating, “I have to worry about Peter as well,” but adding, “I think you know where our hearts are.”

Cole also noted that he and DeLauro see the NIH budget as the subcommittee’s top priority every year, adding that the agency’s activities have aided the effort to control the COVID-19 outbreak. “There will be another coronavirus out there” sometime in the not-too-distant future, Cole said, another reason to keep the upward pressure on the NIH budget.

FDA funds stay available until spent

The supplemental was posted March 4 to the website for the House of Representatives, providing the FDA with $61 million “to remain available until expended.” That amount is directed toward “necessary medical countermeasures and vaccines,” as well as advanced manufacturing for medical products and methods for surveillance of drug and device supply chains.

Another $20 million would be set aside for small business disaster loan programs, while the CDC would receive $2.2 billion, a fund that would expire at the end of fiscal 2021. Of that amount, $950 million is earmarked for grants and cooperative agreements to state, local and tribal authorities, with half that amount required to be allocated within 30 days of enactment.

The National Institute of Allergy and Infectious Diseases would have until the end of fiscal 2023 to make use of $836 million, $10 million of which is designated for training to prevent infection of health care workers. The amount of $3.1 billion, which includes some transfers of funds, would be allocated toward development of countermeasures with an emphasis on diagnostics describe as “platform-based technologies with U.S.-based manufacturing capabilities.” This bolus also expires at the end of fiscal 2023, as does another $300 million designated for purchase of vaccines, therapeutics and diagnostics.

The legislation also stipulates that these funds, which in total amount to $7.8 billion, will be applied to medical countermeasures with the proviso that any such products are affordable so long as affordability does not delay availability. Any products purchased by the federal government can be placed in the Strategic National Stockpile at the discretion of the Secretary of Health and Human Services.

White House had proposed $2.5B for COVID-19

DeLauro opened the hearing by noting that the COVID-19 supplemental was already in negotiation, with only a few details to iron out. She vowed that Congress would move on the legislation as quickly as possible, no later than the end of the week. The Trump administration had filed a supplemental request of $2.5 billion for the COVID-19 outbreak in February, although the administration’s budget proposal for fiscal 2021 would have shaved 10% off the budget for the Department of Health and Human Services.

DeLauro immediately signaled her opposition to the administration’s proposed cuts to the NIH budget, saying that the cuts would have eliminated 1,800 NIH grants. In particular, cuts to the National Cancer Institute’s budget “sends the wrong message,” she said, noting that Congress had provided a 3.3% increase to each NIH institute and center in the current fiscal year’s budget. “We need to keep up that momentum and not reverse it,” DeLauro said.

Francis Collins, director of the NIH, said CRISPR is an example of a technology that can have an outsized impacts on disease, but noted that NIH “must do more to de-risk projects” of this type if the private sector is to become more involved. Congress had set aside $225 million in the current fiscal cycle for infrastructure and facilities, but Collins said, “we are about $2.1 billion in the hole” on such needs. He said NIH has had to close some portions of its clinical infrastructure recently due to floods, adding that the National Academies of Sciences “agrees we need urgent attention to this matter.” Among the items on the NIH wish list for infrastructure is a new radiology wing, Collins said.

Collins said the date of a cure for Alzheimer’s disease is tough to predict, adding that interest in both the amyloid and tau hypotheses persists. However, he remarked, “there are things going on that we didn’t appreciate,” including the fact that both the immune system and lipids seem to play a role in development of Alzheimer’s. More than 50 possible drug targets have been identified over the past year or so, and Collins said the amyloid hypothesis is still in the forefront despite the recent failures. “Watch this space closely,” Collins advised.

Anthony Fauci, director of the NIH’s National Institute for Allergy and Infectious Diseases, reiterated that development of a vaccine for the COVID-19 virus will take at least a year, but added that clinical trials for remdesivir (by Gilead Sciences Inc., of Foster City, Calif.) are underway in Washington and Nebraska.

In response to concerns that the role of diagnostics in the COVID-19 outbreak has been ignored, Fauci said the emphasis is on making the lone available test more widely available and withdrawing the restrictions on who can be tested. He said the test by the CDC “started out with some technical problems” that delayed distribution and usage, adding that the initial set of restrictions have to be withdrawn in order to use the test on those in a community setting who are without an apparent link to a known diagnosis. When prodded on whether the federal government response should be more proactive, Fauci agreed, adding, “I feel strongly about that.”