President's Budget Request: Preliminary Analysis

The President’s Budget Request was released on Friday afternoon and we have begun to unpack the content. Expect a more detailed analysis from the Alliance early next week.Our topline, as provided to the media:

Because of the multiple funding sources and the mix of one-time and base funding, the FDA budget request is always difficult to interpret. Based on the tables available to us, we believe that the Administration's request for budget authority (taxpayer) funding for FDA is $3.559 billion. This is a $344 million increase over the FY 21 adjusted base of $3.215 billion. This is exclusive of one-time items and CURES funding in both FY 21 and FY 22.

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.

The FY 22 request, which covers the period from October 1, 2021, through September 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 This funding will provide vitally needed investments to modernize the FDA’s outdated data infrastructure, ensure labs and facilities are safe, functional, and integrated with program needs and support fundamental FDA operations to keep pace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.

Please contact Steven Grossman, the Alliance’s Executive Director if you have any questions. He can be reached at sgrossman@strengthenfda.org.