While the FDA has received its fair share of vilification and staff have been working very long hours since the pandemic began, President Biden’s 2023 budget request seeks to provide the agency with a major infusion of new funding – 2 $.1 billion, or 34% more than the FDA’s budget this year.
This vast majority of these new funds will go towards preparing for the next pandemic, or the next iteration of the current one. In an HHS-wide total of $81.7 billion in 2023 pandemic funds, $1.6 billion is included for the FDA to expand and modernize regulatory capacity, IT and laboratory infrastructure related to the pandemic.
The FDA’s 2023 budget also requests a total of $4.2 billion, an increase of $253 million from 2022 dollars, for investments in medical product safety.
Building on the success of Rick Pazdur’s FDA Oncology Center of Excellence, the budget calls for an additional $20 million in new one-time funding to support programs that incorporate patient voices, real-world evidence, and collaborations with FDA’s global partners (see Project Orbis) to facilitate faster patient access to new cancer therapies.
“With this investment, the FDA will build on existing efforts to continue to facilitate and expand internal and external collaborations to accelerate oncology and malignant hematology product development, as well as increase diversity and accelerate progress against the deadliest and rarest cancers, including childhood cancers. , and foster the development of new therapies for patients with ultra-rare cancers,” the HHS budget request released on Monday said.
Next year, another $30 million will also be used to help tackle the opioid crisis, with funds to support the development of opioid overdose reversal treatments and treatments for use disorders. drugs, as well as to stop counterfeit drug shipments, and new funding to develop, evaluate, and advance digital health medical devices to address opioid use disorders.
Another increase of $6 million is requested to help lay the groundwork for implementing the 21st Century Roadmap for Modernizing FDA’s Safety Oversight and Surveillance Program for Marketed Pharmaceuticals , an increase of $5 million from FY2022 enacted to continue the implementation of the Predictive Toxicology Roadmap, which will improve the FDA’s ability to quickly and more accurately predict potential toxicities and to reduce the associated risks to the public.
The budget also includes a $54 million increase for the agency’s capacity building efforts, including support for essential services, such as responding to inquiries and subject matter expertise on FOIA requests. , legal services and support efforts that reduce laboratory work risks, improve laboratory safety and data quality, and increase safety and health program effectiveness.
Biden’s budget request also includes a $34 million increase from last year to partially fund planned payroll cost increases for the FDA’s more than 19,000 employees.