The U.S. Food and Drug Administration is requesting a total budget of $6.5 billion as part of the President's fiscal year (FY) 2022 budget – a nearly 8% ($477 million) increase over the agency's FY 2021 funding level for investments in critical public health infrastructure, core food safety and medical product safety programs and other vital public health programs.

The request includes $3.6 billion in budget authority – including $343 million in increases – and $2.9 billion in user fees – an increase of $155 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. 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."

Janet Woodcock, M.D, Acting FDA Commissioner

The FY 2022 request, which covers the period from Oct. 1, 2021, through Sep. 30, 2022, includes the following budget authority increases:

• $185 million in additional investments in FDA's Critical Public Health Infrastructure. The FDA's budget includes funding to support critical public health infrastructure needs including enterprise-wide data modernization, improvements to its federal buildings and facilities, expanded laboratory safety efforts and increased internal capacity to support the agency's growing workforce of over 18,000. This funding will provide vitally needed investments to modernize the FDA's outdated data infrastructure, ensure labs and facilities are safe, functional and integrated with program needs and support fundamental FDA operations to keep pace with new requirements, legislation and regulatory responsibilities.
• $97 million in additional investments in Core FDA Safety Programs. The budget provides increases to core food and medical product safety programs that require significant investments to address unmet public health funding needs, as well as emerging issues of concern. Food safety investments include funding to support implementation of the New Era of Smarter Food Safety Blueprint to reduce the number of illnesses attributed to FDA-regulated foods; bolstering the funding provided to programs which are responsible for maternal and infant health and nutrition; providing much needed additional funds to address numerous emerging food-related chemical and toxicological issues; and strengthening animal food safety oversight. Medical product safety investments include providing dedicated programmatic funding to strengthen and monitor the supply chain; increasing drug safety surveillance and oversight; and improving animal drug safety and predictive technologies.
• $61 million in additional investments in Public Health Issues Confronting the U.S. The budget provides increases to address public health needs and key investments to tackle complex challenges facing the country. Investments include increasing safe and secure inspections, promoting health equity and addressing the opioid crisis by supporting development of new therapies and smarter enforcement.

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 include efforts to:

• Expand the FDA's authorities for device shortages to assure a more resilient domestic supply chain and help reduce dependence on foreign production;
• Expand the FDA's authority to explicitly provide for the ability to request records or other information in advance of or in lieu of inspections to help ensure the availability of emerging and medically necessary products that mitigate, diagnose treat, prevent or cure disease when travel to or inspection of an establishment is inadvisable;
• Expand the agency's authority to require any manufacturer of infant formula, essential medical food for patients with certain inborn errors of metabolism (e.g., phenylketonuria, medium chain acyl-coenzyme A dehydrogenase deficiency) or other designated category of food to provide shortage notifications, at a reasonable time and manner during a declared public health emergency;
• Clarify the FDA's authorities to improve the agency's ability to assess human and animal pharmaceutical critical infrastructure as well as manufacturing quality and capacity, particularly around product discontinuances and manufacturing interruptions;
• Expand the FDA's authorities to require, when likely to help prevent or mitigate a shortage, that a drug sponsor evaluate, submit studies to the FDA and label a product with the longest possible expiration date that the agency agrees is scientifically justified; and
• Extend current provisions related to counterfeit drugs to include medical devices to help keep counterfeit products out of the United States and facilitate enforcement actions against those that find their way into interstate commerce.

These funding and legislative proposals align with the U.S. Department of Health and Human Services' goals of Strengthening National and Global Readiness for the Next Public Health Crisis, Promoting Health Equity by Addressing Racial Disparities, Providing Funding to Reduce the Maternal Mortality Rate and End Race-Based Disparities in Maternal Mortality, Promoting Biomedical Research and Establishing the Advanced Research Projects Agency for Health and Advancing the Goal of Ending the Opioid Crisis.