Last-minute US spending bill features a beginning for ARPA-H, and half of what Biden requested for Covid-19
The House and Senate are again racing against the clock to pass an annual $1.5 trillion government spending bill, with a tight deadline Friday that may have to be briefly extended to early next week.
Under the 2,700+ page bill for 2022, released just after midnight on Wednesday, funding for Covid-related provisions will only hit $15.6 billion after the Biden administration previously requested about $30 billion to help prepare for the next wave of cases.
That total includes almost $10 billion for BARDA to buy more oral Covid-19 antivirals, monoclonal antibodies and vaccines, which will be crucial to ramp up supplies, particularly for Pfizer’s pill. Although the US has purchased a total of 10 million courses of Pfizer’s antiviral Paxlovid, only about 690,000 courses have already been distributed, and only about 100,000 more courses have so far been procured to date.
An additional $750 million in 2022 funds will go toward developing vaccines that protect against future variants. Who will receive those funds remains unknown. And another nearly $4.5 billion will go to an initiative to increase global vaccinations overseas, with an aim for a 70% vaccination rate in every country.
Meanwhile, the spending bill, which is expected to clear Congress and be signed by Biden, also includes $1 billion to kick-start Biden’s newly proposed Advanced Research Projects Agency for Health or ARPA-H. Biden had initially requested $6.5 billion for the NIH-housed research outfit, which is going to mirror DARPA with risky, groundbreaking investments.
ARPA-H’s investments into various research endeavors may include cancer vaccine development, or even ways to make manufacturing processes for patient-specific T cells cheaper and easier.
Meanwhile, the Department of Defense is also doling out $577.5 million for cancer research in 2022, on top of the National Cancer Institute’s $6.7 billion budget. The DoD funds include $150 million for breast cancer research and $110 million for prostate cancer research.
The FDA will receive a total of $3.3 billion in discretionary funding from the bill for 2022, which is a slight increase of $102 million above the FY 2021 enacted level. But the appropriations from Congress make up a little more than half of all total funding for FDA, which also gets $2.9 billion in industry user fees next year.
Within this 2022 total, the House Appropriations Committee provides a targeted increase of $29 million at FDA to address the opioid crisis, medical supply chain surveillance, rare cancers, and increasing and strengthening in-person inspections of foreign drug manufacturers, the appropriations committee said.
No less than $8.5 million is set aside in the FDA’s budget for pilot projects to increase unannounced foreign drug inspections.
Members on both sides of the aisle have criticized the FDA for not conducting more unannounced inspections overseas (whereas FDA often inspects domestic facilities unannounced) although FDA officials have explained that if the appropriate officials are not at the foreign site when the FDA inspectors show up unannounced, the agency can waste resources on organizing such inspections.
The bill also appropriates $50 million to accelerate medical product development as authorized in the 21st Century Cures Act.