The F in FDA: Part 3

As the Alliance has stated previously, no federal agency is more affected by changes in science, technology, innovation, commerce, and social trends than FDA. Moreover, the agency’s mission and responsibilities continue to grow each year. As a result, every part of FDA needs additional resources—larger budgets, more well-trained staff, and modernization of data and IT systems.

The Alliance is the foremost advocate for those additional resources. Within our overall effort, food programs have drawn considerable attention and concern in 2022. Accordingly, this is the third column to articulate the Alliance’s position on FDA’s resource needs for its food safety programs.

The first column (here) explained why “more resources for food programs is an essential complement to the reforms sought by food stakeholders.”

The second column (here) explored the resource needs of CFSAN and CVM through a look-back at the Alliance’s FY 23 “ask.” Our conclusion: there is more than enough need to justify substantial increased funding for food programs.

This third column continues that theme: advocates should focus on the value and resource needs of food programs. Comparisons to other parts of the agency tell us nothing relevant about the needs of food programs. To illustrate that, we explore three of the widely circulated food/medical product comparisons that don’t hold up to scrutiny.

User Fee Maintenance of Effort (MOE): No impact on CFSAN. Every user fee program has a maintenance of effort (MOE) provision to ensure that FDA does not use user fees to substitute for budget authority (BA) funding. MOE could only impact food funding if the FDA were to suffer a large year-over-year cut

However, FDA has sustained only one year-over-year decline since the Alliance became active (FY 07). The exception was 2013, when all agencies faced sequestration cuts. Notably, the appropriations committees gave FDA $150 million extra before the cuts, blunting their impact.

We expect FDA funding will continue to grow. The worst case would be a full-year Continuing Resolution, where funding is limited to the prior fiscal year. Even in that situation, MOE would have no effect on FDA food funding.

CFSAN has had inadequate growth in BA-supported personnel; nonetheless, it has grown faster than other centers. We looked at BA-funded personnel levels among the centers during the decade period between 2012 and 2021. Despite substantial increased BA funding throughout the agency, relatively little was spent on increased personnel levels. What growth occurred was at CFSAN (+200 FTE’s) and CVM (+125). The BA FTE total for the other centers was flat or decreased during this period.

In short, BA increases—which is all the appropriations committees’ control--are not paying for substantial increases in FTE’s anywhere at FDA. However modest the increases, CFSAN did better than other centers.

BA funding has not favored medical products over food programs. The attached chart shows that BA-funded salaries and expenses grew nearly 93% between FY 2008 and FY 2022. The centers/entities that received increases larger than the average were CFSAN (122%), Office of the Commissioner (112%), CVM (108%), and CDER (102%).

The only way to increase FDA food program funding is to document and explain the opportunities and challenges facing food programs. As illustrated above, spurious comparisons to medical products do not tell us what is needed to make our food supply safer.

The more specific we can be, the more likely Congress will see that the food program shortfalls are substantial and responding to them ought not to be delayed. Greater transparency on agency funding could meaningfully contribute to that effort. The more we know about existing food programs and their funding, the more support and the better case we can make.

The Alliance supports larger budgets, more well-trained staff, and modernization of data and IT systems at CFSAN and CVM. The path to get there is to document the needs and show the opportunities for improvement.