Q&As on FDA Allocations: BA vs user fees; medical products vs food safety
Q&As on FDA Funding Allocations
Q: Many of the press reports surrounding the potential shutdown have referred to FDA as “nearly half funded by user fees.” Is this correct?
A: No. When policymakers, media, and the public ask about the mix of appropriations and user fees, what they invariably have in mind is the balance in FDA funding to fulfill the agency’s traditional food safety and medical product responsibilities. On that basis, the split is approximately 60% budget authority (BA) appropriations to 40% user fees. Those claiming a larger proportion of user fees are including more than $700 million in tobacco industry user fee. The tobacco program is 100% user fee funded and it is the only instance at FDA in which industry funds programs that they oppose. Most importantly, tobacco is not part of the agency’s traditional food safety and medical product responsibilities.
Q: How do directed program allocations in the committee reports relate to the overall proposed increases for the agency?
A: The committee reports accompanying appropriations bills almost always include Congressional direction on how some portion of the money should be spent (e.g., in the case of FDA, how much money is to be spent on opioid programs). Often overlooked is that the items cited in report language are not necessarily new funds. In many cases, the allocations in the reports repeat funding directives specified in the prior year’s appropriations committee reports. As a result, the monies are already in the agency’s base funding (i.e., not new or additional funding). Because there is no correlation, the directed funding can mask the amount of new incremental programming that is not directed and how much can be devoted by the agency to initiatives contained in the President’s budget request and not specifically mentioned in committee reports.
Q.: How do the Administration, the House and the Senate allocate funding between FDA’s medical products and food safety programs?
A: The Alliance’s philosophy has been that a rising tide lifts all boats—every year food safety and medical products programs have advanced based on the highest public health and safety needs and FDA’s essential role in the nation’s public health. To our knowledge, nobody applies a formula and says: food safety should get x% and medical products should get y%. We see no evidence that food safety funding has grown at the expense of medical products or vice versa.
When the Administration requests monies, there is a chart that shows how BA would be split between FS and MP (see page 40 in the FY 22 budget request here). Proposed for FY 22 is a $134 million increase for food safety and $189 million increase for medical products. There is also another also another $18 million in new BA under buildings and facilities, for which there is not an allocation.
Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.