Acknowledging that FDA has “been under intense scrutiny during the past year” for an organizational structure that is “not optimal,” Mayne said she fully supports the reorganization announced by FDA Commissioner Robert Califf at the start of the new year, which will bring together under one leader elements of the agency’s food program currently spread across different centers.
The planned reorg follows a scathing report by the Reagan-Udall Foundation, which found “the current culture [at FDA] … is inhibiting its ability to effectively accomplish [its] goal.”
But simply reshuffling existing staff and authority under a new Deputy Commissioner for Human Foods, for which FDA is actively recruiting, is not enough to manifest the level of change called for by Reagan-Udall and other industry stakeholders, Mayne said during a recent webinar hosted by the Alliance for a Stronger FDA.
“The FDA humans’ food program urgently needs additional personnel, financial and IT resources to perform its congressional mandate more effectively,” Mayne said. Quoteing from the Reagan-Udall report sh added, “relatively modest increases in federal budget authority, flat staffing levels and lack of sustained and sufficient commitment to upgrading IT, [contrasts] with the rapidly changing food industry, [and constrict] the ability of the human foods program to carry out its mission efficiently and effectively.”
That is why she says FDA is “going big” in its fiscal year 2024 budget request, which is the largest ever for CFSAN and follows a “banner year for funding for our center” in FY23.
The agency’s proposed $85m increase for core CFSAN programs above FY23, for a total budget of $509m, “would really allow us to set the foundation for a well-resourced, organized and staffed food program as we move into our new future as a unified Human Foods Program,” Mayne said, adding, “improved structures still depend on having the workers needed to execute the growing portfolio.”
‘These new resources would enable us to increase our workforce’
The new funds, if approved by a divided Congress, would go towards several high-profile food safety programs and nutrition enhancing initiatives that respond directly to threats against nearly all congressional constituents, including the agency’s work on maternal and infant health, emerging chemical and toxicological issues and the agency’s new era of smarter food safety.
Specifically, $41m is earmarked for FDA’s Health and Safe Food for All work, which houses FDA’s work on infant formula, Closer to Zero and food chemical reassessment, said Mayne.
Of this, $410m would help higher 21 new staff to oversee the infant formula supply chain, improve surveillance and monitoring of adverse events, refine lab methods for detecting certain bacteria, like coronbacter, increase review capacity, stay current with infant formula innovation and the science around infant nutrition, and modernize critical data and IT systems.
The FDA’s effort to reduce toxic elements in the food supply, including lead in baby food, also would benefit from $12m, which Mayne said would go in part to providing related guidance on best practices, sampling and testing.
“These new resources would enable us to increase our workforce capacity by 18 additional staff and allow us to conduct marketplace sampling and carry out appropriate enforcement actions,” she explained.
Enhanced oversight of food chemicals, new ingredients
An additional $19m would go to beefing up FDA’s work around food chemical reassessment and abundance of new food ingredients, contact materials and production techniques that have “not only increased the pre-market workload of the FDA food program, but it has also increased the complexity of the work to adequately keep up with the current workload while implementing a significant new post-market assessment program,” said Mayne.
She added: “We are going bold here and seeking to hire 40 new personnel to add new data analytic tools as well and modernize our systems emerging chem talks.”
An additional $1m would go to the agency’s work on PFAS to better understand the levels of exposure that have negative impacts on health and the science related to mitigation, such as steps growers and manufacturers can take to reduce contaminants in food, she said.
Funds dedicated to the agency’s oversight of food chemicals also would allow FDA to expand its post-market review of chemicals, allowing it be “in a proactive mode rather than a reactive mode,” Mayne said.
She explained that while FDA does some post-market review of food chemicals currently, it wants to create a more systematic post-market review process based on data, science and risk prioritization.
“What has happened is our pre-market program has grown in terms of what is coming in. Without growth in new resources, there is simply no way that we can divert people to post-market, as we have to complete those pre-market reviews to support innovation. Those are things like food contact notifications, food additive petitions, GRAS notifications, etc. So, we need resources to buildout a robust post-market review program,” she explained.
Will a divided Congress come through for FDA?
FDA’s request to significantly increase its budget comes “in the middle of a fiscally tough environment,” acknowledged Mayne, but she added 2023 is “shaping up to be one of the most transformative years ever for the foods program at the agency, and … we’re going to need … support now more than ever.”
Even if Congress cannot agree to give FDA everything it wants in 2024, Mayne said at a bare minimum it is of “critical importance … not having any cuts or backsliding in funding,” which she said, “could be an enormous detriment to the progress that we have been making.”
She also reminded those gathered by the Alliance for a Stronger FDA that the agency’s food program is “an outlier” in that it does not depend upon user feeds. Rather, 97% of its budget comes from budget authority.
“What that means is, as the workload grows at CFSAN, and eventually into the Human Foods Program, we have to expand our budget to keep up with that, and that has not been the case” for almost the past decade, during which the center’s budget has “remained relatively flat” despite record inflation and increased expectations
“We need Congress to recognize that consumers expect the highest standards. We’ve heard that loud and clear over the past year. And so, in order to have those successes that consumers want and demand, we need resource to help support that,” she said.