The US Food and Drug Administration (FDA) is requesting a total budget of $8.4 billion as part of President Biden’s fiscal year (FY) 2023 budget for investments in critical public health modernization, core food safety and medical product safety programs, and other public health infrastructure.

This request is nearly a 34% ($2.1 billion) increase over the agency’s FY 2022 appropriated funding level. The request includes $3.7 billion in budget authority, including an increase of $356 million, and $3 billion in user fees, an increase of $153 million. The request also includes $1.6 billion in mandatory funding to support the FDA’s ability to prepare for future pandemics.

The FY 2023 request, which covers the period from October 1, 2022, through September 30, 2023, fully funds initiatives previously requested in the FY 2022 budget request and includes new efforts for high-priority program areas, such as pandemic preparedness, advancing access to safe and effective medical products, food safety & nutrition modernization, and core operations.

Pandemic preparedness
The FDA is requesting $1.6 billion over five years to support the its contributions to the US Department of Health and Human Services (HHS) Pandemic Preparedness Plan. The FDA says this budget increase would allow the FDA to modernize its regulatory capacity by strengthening its information technology and laboratory infrastructure. The agency will also focus on 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 supply chain.

Advancing access to safe and effective medical products
The FDA is requesting $20 million as part of the Cancer Moonshot initiative to speed progress in cancer research and improve cancer outcomes. The agency says it will build upon existing programs to advance Moonshot goals.

Additionally, the FDA is requesting $30 million in additional funds to advance the goal of ending the opioid crisis. Funding will address four priority areas of the epidemic, including decreasing exposure and preventing new addiction, supporting the treatment of those with opioid use disorder, fostering the development of novel pain treatment therapies, and improving enforcement and assessing benefit-risk.

The FDA is also requesting a $5-million increase toward improving the safety and security of medical devices and $5 million in additional funding to boost review capacity for premarket animal drug submissions.

Core operations
As part of efforts to increase funding for its core operations, the FDA is requesting the following: (1) $68 million in further investments in data modernization and enhanced technologies; (2) a $100-million increase in user fees to support reducing the use and harms of tobacco; (3) $24 million to optimize inspections and enhance inspectional capacity; and (4) $5 million in new funding for a comprehensive strategy for new, alternative methods for product testing.

To complement the funding requests the agency’s budget proposal also includes a package of legislative proposals designed to bolster the FDA’s authorities to further its mission to protect and promote public health. Notable proposals efforts can be found here.

Source: US Food and Drug Administration