Biden’s first budget request seeks $6.5 billion for FDA

Regulatory NewsRegulatory News | 01 June 2021 |  By 

The US Food and Drug Administration (FDA) is seeking $6.5 billion in funding for FY2022 under President Joe Biden’s $6 trillion budget proposal announced on Friday, an overall increase of $477 million (8%) over the agency’s FY2021 budget.
In a news release, the agency said the $6.5 billion budget would be used for “investments in critical public health infrastructure, core food safety and medical product safety programs and other vital public health programs,” which includes $3.6 billion in budgeting authority and $2.9 billion in user fees.
Investments in FDA’s Critical Public Health Infrastructure would total $185 million and include data modernization ($75.9 million), improvements to buildings and infrastructure ($37.5 million), expanded laboratory safety ($53.5 million) and more internal capacity to support over than 18,000 FDA employees ($17.9 million). FDA noted its data infrastructure is outdated, and the funds will go to supporting current operations as well as to “keep pace” with new regulatory responsibilities, requirements, and legislation.
Core FDA Safety Programs would also be increased under the proposed budget, with $97 million allocated to safety programs for food and medical products. The agency aims to reduce food-borne illness from FDA-regulated foods through the New Era of Smarter Food Safety Blueprint and oversight of animal food safety ($22.0 million). Additionally, funding for Core FDA Safety Programs would go to programs associated with maternal and infant health and nutrition ($18.0 million), assessing food-related chemical and toxicological issues ($19.7 million). On the medical products side, funding to Core FDA Safety Programs will increase safety and oversight of FDA-regulated drugs and animal drug safety ($5.6 million), predictive technologies ($7.5 million) as well as “dedicated programmatic funding to strengthen and monitor the supply chain” ($23.9 million).
Another $61 million is dedicated to investments in public health issues “to address public health needs and key investments to tackle complex challenges facing the country,” such as more safe and secure inspections ($18.8 million), issues surrounding health equity ($4.7 million), and tackling the opioid crisis ($38.0 million).
“The investments outlined in the FDA’s budget request will advance the agency’s immediate priorities and funding needs. This includes important funding for critical public health infrastructure like our data modernization efforts, as well as investments in core safety programs such as our inspection and surveillance work and initiatives to improve maternal and infant health. The budget request also seeks increases to help address complex challenges facing the country such as the ongoing opioid crisis and promoting health equity among underserved communities,” said Acting FDA Commissioner Janet Woodcock. “We look forward to continuing to work with Congress to ensure the FDA has the resources it needs to carry out our vital mission to protect and promote public health.”

Reactions from advocacy groups 

In a statement responding to the announcement, the Alliance for a Stronger FDA said that the multiple funding sources and combining of one-time funding and base funding within the FDA budget request makes it difficult to interpret. The alliance’s preliminary estimation puts FDA’s budget authority funding at $3.559 billion for 2022, which is an increase of $344 million from the previous year. “This is exclusive of one-time items and [21st Century Cures Act] funding in both FY21 and FY22,” they said. (RELATED: Trump’s 2021 Budget Request Seeks Modest Funding Increase for FDA, Regulatory Focus 10 February 2020).
“If that is confirmed by further analysis, the Alliance for a Stronger FDA will be pleased and supportive of the Administration’s request for FDA,” they said.
Non-profit advocacy alliance group Research!America applauded President Biden’s budget request as a whole and praised FDA’s role in responding to COVID-19. “It would be difficult to overstate the crucial role FDA played in responding to COVID-19 or the agency’s overall responsibilities in moving medical interventions – from tests and other technologies to prescription medicines and biologics and from the lab to the patient,” Mary Woolley, president of Research!America, said in a statement. The increased funding, she said, “will help assure FDA can meet its crucial, multi-faceted mission.”
FDA Justification
FY 2022 FDA Budget Request
Budget of the U.S. Government, Fiscal Year 2022


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Tags: Biden, Budget, FDA, US

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