FDA Seeking $8.4 Billion to Further Investments in Public Health

The U.S. Food and Drug Administration is requesting $8.4 billion as part of the President’s fiscal year (FY) 2023 budget. This funding is planned to cover FDA’s investments in a wide variety of public health initiatives, including food safety, medical product safety programs, pandemic preparedness, and other public health infrastructure. The agency’s request of $8.4 billion represents an increase of almost 34% from last year’s funding.  

“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 FDA Commissioner Robert M. Califf, MD. Califf noted that the request for increased funding would allow the FDA “to leverage opportunities to protect and advance the health of every American with reliable and science-based information.” 

Of particular note for the blood and biotherapies community, FDA’s proposed budget includes funding to promote “science-based decisions in all areas, including with regard to blood donor deferral policies.” In its justification for its budget request, FDA reaffirmed its support for the Transfusion Transmissible Infections Monitoring System (TTIMS) and its benefits to ensuring the continued safety of the U.S. blood supply “FDA has made investments to support TTIMS over the last several years and continues to evaluate deferral policies based on available scientific evidence,” the report stated. 

FDA also noted it will continue to fund the ADVANCE (Assessing Donor Variability and New Concepts in Eligibility) study, which is collecting data to help determine if a donor history questionnaire based on individual risk assessment would be as effective as time-based deferrals in identifying individuals at risk of transmitting HIV by blood and blood components. “This is an issue the agency takes seriously, and we will continue to communicate and share information with stakeholders,” the report stated. 

The budget proposal also includes legislative proposals “designed to bolster the FDA’s authority to further its mission to protect and promote the public health.” Proposals include an effort to assure a more resilient domestic supply chain for medical devices, which would include authority to require certain firms to provide notification of potential shortages with production volume information. It would also establish a requirement for device manufacturers to perform risk assessments, implement risk management plans and identify alternate suppliers and manufacturing sites. 

Members with questions may contact regulatory@aabb.org.