The Food and Drug Administration is preparing for a highly anticipated announcement next Tuesday on the direction of its human foods program following a scathing report from a Reagan-Udall Foundation panel last month that recommended wide-ranging improvements.
FDA has been under pressure by trade groups and others to name a deputy commissioner for food that oversees all the agency's food-related programs.
Other priorities for the agency this year include finalizing the Food Safety Modernization Act’s agricultural water rule and reauthorizing the Animal Drug User Fee Act (ADUFA).
Andi Fristedt, FDA’s deputy commissioner for policy, legislation and international affairs, said in a recent webinar sponsored by the Alliance for a Stronger FDA that FDA Commissioner Robert Califf has been focused on the work of the agency's foods program.
“There will be a lot of work happening this year around really thinking about what an optimized FDA foods program looks like in terms of really continuing to advance our food safety work,” Fristedt said. “Food is safer than it's ever been. And we are really committed to making sure that continues to be the case.”
A cross-section of stakeholders continues to believe the most important action Califf could take in addressing the structural shortfalls at FDA is to name an empowered deputy commissioner for food, which he could do without the approval of Congress.
Sarah Gallo, Consumer Brands Association“It’s unclear at this point if this is the direction that the commissioner wants to go,” Sarah Gallo, Consumer Brands Association vice president of product policy, told Agri-Pulse. However, a diverse array of public interest and industry groups, as well as FDA’s own employees and Capitol Hill lawmakers, all support naming an FDA deputy commissioner of foods to be the point person on food safety and nutrition issues.
Mitzi Baum, CEO of the consumer-focused organization STOP Foodborne Illness, told Agri-Pulse that naming a deputy commissioner with "line authority" could bring the food program together. “That might not be what the agency looks like in their final edition, but that is certainly an action that the commissioner could take today to begin to make the changes. It can be temporary while they focus on what the agency should look like for the future.”
The infant formula recall and the subsequent shutdown of Abbott Laboratories' Sturgis, Michigan plant, is an example of a “perfect storm” that brought FDA’s issues to the forefront, Baum said, adding that FDA’s handling of the crisis revealed many shortfalls with how FDA operates in silos independent of one another. Baum said a deputy commissioner of foods who is an expert in food and food safety can help align those silos.
“Consumers always end up paying the price for failure. And in this case, two infants died and many more illnesses occurred,” Baum said.
If the anticipated FDA plan unveils a massive overhaul but doesn’t align with at least some of the suggested changes called for in the report, it will not meet the growing number of critics calling for change at FDA, Gallo said.
“Moving the squares and rearranging the chairs is not what is needed,” Gallo said. She said the culture and structure sections of the Reagan-Udall report were “screaming for something to happen” and Califf has the ability to do that.
Healthy foods label: The White House Conference on Hunger, Nutrition and Health last September brought some needed attention to the role food can play in health, Stephanie Goodwin, senior manager of government and industry affairs at Danone North America, told Agri-Pulse. As part of that conference, FDA opened a public comment process for its proposal to update the “healthy” claim for food labeling.
Goodwin said she supports the proposed updates, but she and others will be watching closely to see how it evolves. FDA’s research evaluating a potential symbol to designate “healthy” and front-of-label packaging also will see significant advancements this year. Goodwin said she believes FDA will follow science-based information when incorporating stakeholder feedback.
FSMA rules: In addition, major work remains for FDA on finalizing many of the provisions of FSMA. Fristedt said FDA just finished the FSMA food traceability rule in 2022 and will be finalizing the agricultural water rule this year, laying out testing requirements for sources of water used to irrigate and wash produce. “We’re really looking forward to continue to work toward finalizing that rule,” she said.
President Barack Obama signed FSMA into law in January 2011, and after 12 years Baum said consumers are still waiting for final implementation of the major food safety legislation.
“The ag water rule continues to move incredibly slow, at a glacial pace,” Baum said, while observing that E. coli outbreaks continue to occur in leafy greens. And once FDA puts out the final rule, projected by October, it will then take another three years to implement.
“While it gets ramped up, the consumers again will continue to pay the price. There needs to be a sense of urgency,” Baum said.
ADUFA reauthorization: The Animal Drug User Fee Act and Animal Generic Drug User Fee Act (AGDUFA) expire on Sept. 30 and require congressional action to allow FDA to continue to collect user fees that help fund registration activities by the agency. The agreement allows animal drug companies to pay fees to FDA to supplement government appropriations and hire more drug reviewers to speed the approval process.
Ron Phillips, Animal Health Institute’s senior vice president of policy, told Agri-Pulse if ADUFA isn’t reauthorized, “that would have a fairly catastrophic effect on FDA’s ability to review new animal drugs” as the reviewers funded by those user fees would go away.
Phillips said they hope the reauthorizations will move “swiftly and cleanly.”
When Fristedt was asked whether animal biotechnology will be part of the animal drug user fee package, she responded, “I have no idea.” She noted that animal biotechnology is “a place where there’s a lot of interest right now, a lot of engagement by the agency.”
Phillips said FDA met the Jan. 15 deadline to deliver its proposal to Congress, putting future action in congressional hands to get approval ahead of the Sept. 30 expiration date.
Fristedt said usually the animal drug user fee bills provide an opportunity for FDA to engage with those on Congress on the importance of agency's work.
Budget increases criticized: Stakeholders and a Republican-controlled House focused on spending less will require FDA to be more transparent in its budget requests for the upcoming fiscal year. The fiscal 2024 budget request is not likely to be sent to Congress until late February or early March, as opposed to the traditional first Monday in February, Fristedt said.
Gallo said FDA will not gain industry support for increased funding without additional transparency. “We’ve been very clear that we are not going to advocate for additional funding for FDA until they can provide greater transparency around how the money is currently being spent.”
Gallo added that FDA needs to account for how it specifically plans to spend its money. "We know Congress has given significant amounts of funding for FSMA implementation, yet there are more than a dozen FSMA guidances that we’re still waiting on,” she said.
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