FDA seeks $8.4B in FY2023 to modernize regulatory infrastructure, prep for future pandemics

Regulatory NewsRegulatory News | 28 March 2022 |  By 

The US Food and Drug Administration (FDA) has requested $8.4 billion in President Biden’s FY2023 budget, a $2.1 billion (34%) increase over the previous year.
FDA said in a press release announcing the request that the additional funds—an increase of $356 million in budget authority and $153 million in user fees from the FY2022 budget—would be used for “investments in critical public health modernization, core food safety and medical product safety programs and other vital public health infrastructure.” The agency’s budget request also asks for $1.6 billion over the next 5 years to help prepare for future pandemics. (RELATED: Biden’s first budget request seeks $6.5 billion for FDA, Regulatory Focus 1 June 2021)
“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. The FDA has focused our budget request on some of today’s most urgent needs such as human and animal food safety, medical device security and e-cigarette oversight. We also continue to look ahead at our role in public health, including at ways to modernize our efforts to keep pace with evolving science, technology and potential public health emergencies,” FDA Commissioner Robert Califf, said in a press release. “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 FDA wants $68 million to further invest in their data modernization initiative, which they said will assist with “critical enterprise technology capabilities.” The agency sees data-informed capabilities like artificial intelligence, machine learning, and blockchain technologies as “critical” to supporting FDA’s public health priorities, they said, and data modernization will let FDA review large amounts of data in a shorter timeframe, which could help recognize safety signals or detect emerging outbreaks.  
An additional $100 million in user fees will be used to increase oversight of e-cigarettes and Electronic Nicotine Delivery System (ENDS) products “to support the FDA’s mission of reducing the use and harms of tobacco.”
FDA requested $30 million to help combat the opioid crisis through supporting patients with opioid use disorder receiving treatment, reducing the number of new addictions, focusing on novel pain therapies, and “improving enforcement and assessing benefit-risk.”
FDA has asked for $24 million to bolster inspections, which would be allocated to recruit and train new investigators and increase inspectional tool use to “keep pace with rapidly expanding industry including medical counter measures and advanced manufacturing.”
To advance the Biden administration’s Cancer Moonshot, FDA requested $20 million for “research, external collaborations and educational outreach programs” in support of the initiative as well as support for existing development and regulation of products under the Oncology Center of Excellence and other programs.
The agency wants to develop a “more comprehensive cybersecurity program” for medical devices and requested $5 million to allocate towards the safety and security of medical devices. The program would help pinpoint vulnerabilities in medical systems, device manufacturing, and during consumer use. FDA would also use funding to hire staff dedicated to the cybersecurity program and issue grants and contracts for “infrastructure geared towards addressing emerging cybersecurity challenges.”
The FDA said $5 million would go to developing a New Alternative Methods Program intended to “replace, reduce, and refine animal testing” across the agency. “New alternative methods have the potential to provide both more timely and more predictive information to accelerate product development and enhance emergency preparedness,” FDA said.
Preparing for future pandemics
As part of the contribution to the Department of Health and Human Services (HHS) Pandemic Preparedness Plan, the FDA requested $1.6 billion to shore up its information technology (IT) and laboratory infrastructure over a period of 5 years.
“The FY 2023 Budget makes transformative investments in pandemic preparedness and biodefense across the U.S. Department of Health and Human Services’ public health agencies to enable an agile, coordinated and comprehensive public health response to future threats and protect American lives, families and the economy,” FDA wrote. “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.”
Responding to the request, the Alliance for a Stronger FDA said they endorse the increase in FDA’s budget for FY2023. “We will be reviewing the detailed budget request to provide additional information about the strengths of the request and any areas in which we think additional emphasis is needed," they said in a statement.
FY 2023 FDA Budget Summary
White House Fact Sheet on FY2023 budget


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