President’s FY 23 budget request FAQ’s
Top-Line:
Analysis and Commentary: So Many Questions About FDA Funding. We Have Answers.
Administration seeks FY23 FDA Increase: $336 Million More in BA/ $3.653 Billion Total
New Resources Would Support Broad Range of FDA Programs
Alliance Encourages Members of Congress to Request Increased FDA Funding
Hear FDA Leaders Discuss FY 23 Budget Priorities as Part of this Exclusive Alliance Webinar Series
Patrizia Cavazzoni, MD | CDER | April 4, 2 p.m. | Register
Judith McMeekin | ORA | April 6, 2 p.m. | Register
Susan Mayne, PhD | CFSAN | April 12, 11 a.m. | Register
Steven Solomon, DVM | CVM | April 22, 3 p.m. | Register
Jeff Shuren, MD | CDRH | April 29, 11 a.m. | Register
Peter Marks, MD | CBER | May 10, 1 p.m. | Register
Why Sign-up to Listen to Dr. Cavazzoni (April 4).
Why Sign-up to Listen to Judy McMeekin (April 6).
This week’s Analysis and Commentary looks at the President’s budget request through the lens of questions we’ve been asked and answers we’ve provided.
President Requests $336 Million Increase in BA Funding for FDA. If the President’s budget request were to be adopted by Congress, the agency would receive BA funding of $3.653 billion in FY 23. In addition, the President requested no-year money to support the Cancer Moonshot ($20 million) and the agency’s pandemic response activities ($1.6 billion). The FDA Budget Summary Fact Sheet can be found here.
In a media release, the Alliance responded: “We support the Administration’s BA request of $3.653 billion plus proposed no-year money requests for pandemic response and the Cancer Moonshot. The BA request represents an increase of $318 million in BA salary and expenses (S&E) and an increase of $18 million in BA buildings and facilities (B&F).”
New Monies Would Support Broad Range of FDA Programs. Overall, the proposed new BA funding would “enhance food safety and nutrition, advance medical product safety, improve core operations, and modernize FDA’s infrastructure, buildings, and facilities.
The Administration identified four priorities in its Budget Request:
Investing in Core Operations The budget supports cross-cutting agency-wide efforts that provide resources, technology, capacity, and infrastructure to address public health needs and tackle complex challenges due to advances in the global food and medical product technology and supply chains.
Enhancing Food Safety and Nutrition FDA’s budget supports new funding towards ensuring healthy and safe food for every American.
Advancing Medical Product Safety The budget provides monies to a $95 million increase for FDA’s medical product safety work.
Modernizing Infrastructure, Buildings and Facilities FDA’s facilities budget includes an increase of $40 million for the upkeep and rental of FDA’s laboratories and buildings.
Alliance Campaign Encourages Members of Congress to Request Increased FDA Funding. During March and April of each year, Members of Congress ask their constituents and interested parties to recommend program funding for the coming fiscal year. In turn, Members formulate a list of their priorities, which they share with subcommittee leadership. Requests can be highly localized (monies to rebuild a bridge) or broadly programmatic (increases for FDA, for example).
The House Appropriations Committee’s Subcommittee on Agriculture and FDA has set its deadline for input from Members as April 28. However, several individual members have already set their personal office deadlines as mid-April or sooner.
Accordingly, we have set remote Hill meetings for next Tuesday (April 5) and next Thursday (April 7). There are still open slots for those days, so if you would like to participate, please contact Elisa Bayoumi. Stay tuned for more opportunities to participate: these are the first two of six days spread across April and May that will take the place of a single in-person Hill Day. We will need your help.
FY 23 Budget Season Has Officially Started. Hear FDA leaders discuss their FY 23 budget priorities as part of this exclusive Alliance webinar series.
Patrizia Cavazzoni, MD | CDER | April 4, 2 p.m. | Register
Judith McMeekin | ORA | April 6, 2 p.m. | Register
Susan Mayne, PhD | CFSAN | April 12, 11 a.m. | Register
Steven Solomon, DVM | CVM | April 22, 3 p.m. | Register
Jeff Shuren, MD | CDRH | April 29, 11 a.m. | Register
Peter Marks, MD | CBER | May 10, 1 p.m. | Register
These online events are for Alliance members and media, although we welcome guests. If you are not an Alliance member and would like to participate, please contact Alliance Executive Director, Steven Grossman.
Why Sign-Up to Listen to Dr. Cavazzoni (April 4)? The Center for Drug Evaluation and Research ensures that safe and effective drugs are available to improve the health of the people in the United States. Its broad responsibilities include new drugs, generic drugs, over-the-counter drugs, and biosimilars. Dr. Patrizia Cavazzoni will discuss CDER’s FY23 budget priorities, as well as its resource needs.
Why Sign-up To Listen to Judy McMeekin (April 6)? The responsibility for inspections, compliance, and enforcement is centralized in the Office of Regulatory Affairs (ORA), run by Judy McMeekin, the Associate Commissioner for Regulatory Affairs. ORA monies are spread throughout the FDA budget and account for 20% of FDA’s entire budget (about $1.2 billion) and more than a quarter of all employees (about 5,000). She will discuss her FY23 budget priorities, as well as provide updates on achieving pre-pandemic inspection levels.