President's Budget Request Confirmed for FY 22

After further review, we can confirm that the President’s request is for $343 million in additional budget authority (BA) (taxpayer) funding. The Alliance is committed to advocating for this number and will amplify this message to Congressional offices over the next ten days. We urge Alliance members and other FDA stakeholders to do the same.In the associated chart, we provide the break-out by center and function of the proposed increase in BA funding. We have then included text (from FDA) that details the agency’s three major themes and the allocated increase to each specific initiative within each theme. To crosswalk from these initiatives to the center to which the monies are allocated, requires a deeper dive into the budget text and tables. Short of that level of detail, the two-page chart provides an accurate picture of the President’s request.Many Alliance members and journalists have asked about the apparent inconsistency in the statements about the size of the proposed increase in FDA’s BA funding. We have been using +$343 million, which aligns with the total amounts in FDA’s description of its three major themes and included initiatives.Historically, the Alliance has tracked the BA Salaries and Expenses (S&E) portion of the FDA budget. This is where program and policy activities of the FDA are paid for by taxpayers. There is a second component to BA funding that is entitled, Buildings and Facilities (B&F). The B&F allotment has been at $12 million annually for several years. It is for more routine maintenance and unlikely to have an impact on programs and policy.For FY 22, the Administration has presented a more holistic approach to investing in a stronger FDA. Accordingly, the three major themes and their component initiatives combine a $325 million increase in BA S&E and an $18 million increase in BA B&F funding for a total of $343 million in requested new BA monies. (Source here and below: Major Activities Table, page 40 in the CJ.) The B&F increases are intended to go well beyond routine maintenance.Here are some interesting facts and figures from the President’s FY 22 budget request:

• Adjusting for the inclusion of B&F monies, FDA received $3.172 billion in BA funding in FY 20, $3.214 billion in FY 21, and is proposed by the Administration to be $3.557 billion in FY 22. This is exclusive of one-time monies and CURES funding.
• The proposed increase for BA funding at FDA exceeds 10%. We believe this is commensurate with the degree to which FDA’s mission and responsibilities have grown over the last few years due to increased workloads, more complex science, new technologies, and an enlarged scope of responsibilities.
• The President’s budget would add nearly $135 million to food safety programs, nearly $190 million to medical product programs and $18 million to BA buildings and funds (although it is not clear how FDA allocated so-called cross-cutting initiatives to derive these numbers).

Let us know your questions (sgrossman@strengthenfda.org) and we will attempt to answer them individually or through an FAQ document.Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.