US FDA seeks US$8.4 billion in budgetary allocations to steer public health reforms in 2023

USA – The US Food and Drug Administration has requested an allocation of US$8.4 billion for investments in critical public health modernization, core food safety and medical product safety programs, and other vital public health infrastructure.

The budgetary proposal, which forms part of the President’s fiscal year 2023 budget represents nearly 34 percent increase over the previous year’s US$6.3 billion.

The request includes US$3.7 billion in budget authority, which includes a US$356 million increase, and US$3 billion in user fees, which includes a US$153 million increase.

Preparing for future pandemics

The FDA requested US$1.6 billion to shore up its information technology (IT) and laboratory infrastructure over a five-year period as part of its contribution to the Department of Health and Human Services (HHS) Pandemic Preparedness Plan.

FDA Commissioner Dr. Robert M. Califf said in a statement: “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.”

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,” he added.

Data modernization

The FDA wants US$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.

Data modernization will let FDA review large amounts of data in a shorter timeframe, which could help recognize safety signals or detect emerging outbreaks.

A further US$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 tobacco use and harms.”

The FDA requested US$30 million to combat the opioid crisis by assisting patients receiving treatment for opioid use disorder, reducing the number of new addictions, focusing on novel pain therapies, and “improving enforcement and assessing benefit-risk.”

The FDA has requested US$24 million to increase inspections, which would be used to recruit and train new investigators as well as increase the use of inspectional tools in order to keep pace with rapidly expanding industry, including medical countermeasures and advanced manufacturing.

To support the Biden administration’s Cancer Moonshot, the FDA requested US$20 million for research, external collaborations, and educational outreach programs, as well as support for existing product development and regulation under the Oncology Center of Excellence and other programs.

The agency wants to create a “more comprehensive cybersecurity program” for medical devices and has requested US$5 million to fund medical device safety and security.

The program would aid in the detection of flaws in medical systems, device manufacturing, and consumer use.

The FDA would also use the funds to hire cybersecurity program staff and to award grants and contracts for infrastructure geared toward addressing emerging cybersecurity challenges.

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