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Senate proposes $16B to fund the next wave of Covid-19 vaccines
Senate proposes $16B to fund the next wave of Covid-19 vaccines, therapeutics in 2023
Don’t call it Operation Warp Speed 2.0, but Senate Democrats on Thursday proposed $22 billion in 2023 emergency supplemental funding for the next phase of the pandemic, including $16 billion to support the R&D, manufacturing, purchase, and distribution of vaccines, therapeutics, diagnostics and other medical countermeasures.
The influx of new funds, if passed and agreed to with their House counterparts, would arrive as, according to the US government spending website, Washington has already spent $3.83 trillion in response to Covid-19.
The Senate proposal also follows the House of Representatives’ decision in March to pass its own 2023 spending bill, but without the nearly $16 billion in Covid relief as Republicans accused the White House of requesting too much, and not being honest about the government’s pandemic needs.
But the Senate is plotting to allow for flexible funding to help HHS purchase and distribute Covid vaccines, therapeutics, and diagnostics, as well as to fund clinical trials for vaccines focused on emerging coronavirus variants, and to support domestic manufacturing.
Senate Appropriations Committee Chair Patrick Leahy (D-VT) said in a statement, “It is my hope that by releasing these bills, and making clear what the priorities of Senate Democrats are, we can take a step closer toward reaching a bipartisan compromise after months of stalled negotiations.”
The bill would also include $10.5 billion (a 24% increase) for the CDC, as well as $860 million (a 32% increase) to increase routine vaccination rates, detect and respond to outbreaks of vaccine-preventable diseases, as well as to address vaccine hesitancy. Another $740 million would go to supporting state and local public health departments’ emergency preparedness while $600 million would go to tripling the funding for public health infrastructure and capacity.
Senate on FDA spending
For the FDA, the Senate committee’s bill offers a little bit less than what the House already passed, although it would still be an increase of $229 million in discretionary funds over 2022. The bill also includes $5 million to implement the ACT for ALS, which requires the FDA to publish and implement a five-year plan to help develop investigational drugs for ALS and other rare neurodegenerative diseases.
On pharma manufacturing, the Senate committee expressed concerns about Americans’ access to essential medicines, and the committee directs the FDA to provide a report within six months on domestic and foreign manufacturing of drugs included on FDA’s list of essential medicines, published in October 2020.
The committee also raised concerns on “the escalating cost of specialty cancer drugs and biologics,” noting that sponsors commonly “pursue labels at the maximum tolerated dose, despite the high cost, and which often results in significant side effects.”
The committee notes that several studies have demonstrated cost savings from alternate dosing strategies for oncology drugs, without impacting efficacy.
“The Committee acknowledges FDA’s recent premarket dose selection efforts under Project Optimus, led by the Oncology Center of Excellence. The Committee strongly encourages FDA to organize clinical trials, in collaboration with academic medical centers and other Federal agencies, of marketed cancer drugs and biologics to assess whether dosing and frequency adjustments may decrease the cost of care and/or toxicities of treatment without compromising efficacy,” the committee adds in its explanatory statement.
# COVID
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