The US Food and Drug Administration has revealed its requested budget for President Joe Biden’s fiscal year (FY) 2023 budget. The total ask of $8.4b USD amounts to a nearly 34% ($2.1b USD) increase over the FDA’s appropriated funding level for investments in a range of food, drug, and public health programs; the President’s total proposed budget for the US government is $5.8t USD.
“The funding outlined in this year’s FDA budget request is critical to fulfilling the agency’s mission as we continue our work on a wide range of COVID-19 and non-COVID priorities,” said newly installed FDA commissioner Robert Califf. “Additional funding brings new ways to leverage opportunities to protect and advance the health of every American with reliable and science-based information. We look forward to continuing our work with Congress to help meet the critical public health challenges ahead.”
The budget requests include $20m USD for efforts associated with the Cancer Moonshot program, aimed at accelerating progress in cancer research and improving cancer outcomes. The request provides a one-time infusion of funding to advance a range of research, external collaborations, and educational outreach programs; additionally, it will work on the continued support of the development and regulation of oncology medical products through the Oncology Center of Excellence.
The FY 2023 budget requests also include a $5m USD that would go toward improving the safety and security of medical devices. According to the agency, development of a more comprehensive cybersecurity program for medical devices could pinpoint and avoid vulnerabilities along the pipeline.
The requested allotments also include $30m USD that would help fund the national goal of ending the opioid crisis. The priority areas of this effort include fostering the development of novel pain treatment therapies.
Also, the list includes $1.6b over five years to support the agency’s share of contributions to the Department of Health and Human Services (HHS) Pandemic Preparedness Plan. The FY 2023 Budget lays out investments in coordinated pandemic preparedness and biodefense across multiple agencies to enable the response to future threats in order to protect American lives as well as the economy.
The FY 2023 budget increase also reportedly would empower the FDA to modernize its regulatory capacity by strengthening its IT and laboratory infrastructure. The agency also plans to focus on the evaluation of vaccines and therapeutics to respond to any future pandemic or high-consequence biological threat, facilitation of rapid development of diagnostics. and work to support efforts to expand the personal protective equipment (PPE) supply chain.
Other investments enumerated in the proposed budgets include:
- $68m in investments toward data modernization and enhanced technologies
- $24m to optimize inspections and inspectional capacity
- $5m in funding for a comprehensive strategy for new, alternative methods for product testing
The proposed budget also encourages accelerated drug and biologic approval, amendment of the Hatch-Waxman 180-day patent challenge exclusivity provisions, destruction of imported products that have been refused by the agency, and creation of a more resilient domestic supply chain for medical devices.