In the summer of 2022, Rep. Rosa DeLauro and Sen. Dick Durbin introduced the Food Safety Administration Act, which essentially calls for FDA to be divided into two agencies: one responsible for food and one responsible for drugs/medical devices.
“Food safety is currently a second-class citizen at the FDA,” DeLauro said when she introduced the bill. “Right now, there are no food policy experts in charge of food safety at the FDA. That is unacceptable and contributes to a string of product contaminations and subsequent recalls that disrupt the supply chain, contribute to rising prices, and in many cases, result in consumer illness and death.”
One needs only to look at 2022’s infant formula crisis, in which Abbott Laboratories’ Sturgis, Mich., facility was allegedly responsible for producing formula contaminated with Cronobacter sakazakii, to understand the Senator’s concern.
This type of issue is one reason the bill is looking to create a single food safety agency, led by a food policy expert, to ensure the safety of products that go to market.
Tyler Williams, CEO of ASI Food Safety, which oversees the certification process in more than 3,000 audits annually and has trained and consulted with numerous major food and beverage companies around the world to help improve their food safety practices, notes that longtime critics of FDA have been pushing for a split in the agency for several years. “Food safety experts argue that food safety and security is a secondhand thought after drugs and medical devices, whereas the pharmaceutical industry feels drug approvals are slowed down by the FDA being distracted by food industry recalls,” Williams says. “It feels like the food sector has been the red-headed stepchild of the FDA, or maybe the agency just simply has too much on its plate, but either way, the legislation being introduced by food policy experts calls for a division of power that will hopefully prioritize food safety and protect consumers.”
Cassandra LaRae-Perez, a food and beverage attorney at Gravel and Shea in Burlington, Vt., notes that proponents of the bill argue that a separate agency would bring leadership more focused on food safety, more accountability, and a unified and efficient structure, but it is unclear how a separate agency would perform better, and whether additional resources would be devoted to ensuring its success. “In short, the bill seeks to tighten regulation on food producers and to increase credibility and autonomy of the regulators responsible for food safety, but without a significant, perhaps outsized dedication of monetary and human resources and willing participation in the Senate to swiftly appoint a leader for the agency, it’s not clear how its aims can be achieved,” she says.
Reagan-Udall Foundation Report
Brian Ronholm, director of food policy for Consumer Reports, says that FDA has inadequately responded to outbreaks and missed deadlines for implementing critical food safety initiatives, which has undermined consumer confidence in the agency’s food program. “One of the big proposals that gets support is creating an empowered deputy commissioner position that would have oversight authority over the foods program at the agency,” he says. “That would put someone in charge of food, because that’s what is lacking.”
In July 2022, a few months after the infant formula crisis that was responsible for the death of at least two infants, FDA commissioner Robert Califf, MD, commissioned a review of the Human Foods Program by the Reagan-Udall Foundation, an independent group of experts. Their findings, released in December 2022, recommended a major overhaul and reform of FDA, essentially backing up the bill.
David Acheson, founder and CEO of The Acheson Group and former FDA associate commissioner for foods, notes that a split isn’t a new idea, but legislation has never gained much traction before. He says Dr. Califf’s call for the Reagan-Udall Foundation report is a good sign—much needed—that change is possible.
The report outlined several key problems within the agency’s culture, structure, resources, and authority. “The report uncovered several issues ranging from reporting structures and clear lines of authority to a lack of a clear and compelling vision, mission, and value statement specific to the Human Foods Program,” Williams says. “While some of these issues could be fixed with an agency split, most of these issues require a cultural change from a reactive approach to food safety to a proactive approach.”
Some recommendations from the report to improve the agency included requesting records from food manufacturers in advance of or in lieu of an inspection; being notified when designated food categories, such as infant formula, are likely to experience shortages or when supply chain disruptions are anticipated; expanding the criteria for suspension of registration for food facilities; invoking civil monetary penalties for various violations; and granting administrative authorities that allow FDA to use a progressive enforcement strategy that does not require a determination of serious adverse health consequences or death to humans or animals.
Additionally, the report recommended that FDA be bolder in strengthening its implementation and use of existing FSMA authority to collect user fees; use its mandatory recall authority more frequently—especially for life-sustaining products that are the only source of nutrition for certain populations; and more effectively identify opportunities to monitor both industry and consumer behavior to better understand industry implementation and consumer response to FDA’s nutrition initiatives.
Some recommendations called for radical changes within the agency, Acheson says, and now the industry is waiting for Dr. Califf to respond. “The priorities on the hill are not this, however, so, it may be more about what can be done without congressional approval, and that would mean an internal restructuring,” he adds. One example of this restructuring could involve creating a new component within FDA that would effectively contain everything that a new agency would contain, but with lower costs being and without the disruption and need for statute change, which Acheson believes is highly unlikely at the moment, despite the bill.
The Advantages of an Agency Split
While it’s hard to say whether there would be any immediate benefits for either industry or consumers without seeing a detailed action plan, Acheson believes one of the biggest potential benefits of separating FDA into two agencies is having a split leadership team. “Currently, most of FDA’s leadership comes from the drug and medical device industry,” he says. “By splitting the agency, we could see leaders with extensive knowledge in the industry they are regulating ensuring that doctors are not responsible for developing food safety policies and food safety experts aren’t weighing in on drug approvals.”
Additionally, a potential split of FDA between food and drugs could lead to a potential merger between USDA’s food safety responsibilities and those of FDA. “We’ve experienced so many issues within the food supply chain that come from the farming sector, later trickling down to manufacturing, then to retail, that it has left many food industry professionals questioning the separation of powers between the two agencies,” Williams says. “Due to the already existing overlap between the FDA and USDA, this could make regulating these products much easier in the future.”
Is a Split Really Possible?
While there are plenty of advocates for a split, making it happen would come with challenges. FDA would need to allocate team members to oversee each sector, hiring more experts to work on one side of the agency or even both, to keep things moving. Challenges within the food supply chain or the drug supply chain may also be burdensome.
Still, Williams says, “Never say never.”
“I think if the FDA is supportive of it, Congress will likely align with whatever the FDA thinks is best, as long as it’s not costing them more money,” he adds. “However, the split could mean a more immediate need for an increase to the FDA’s budget, which some members of Congress would likely not support. I also think the push from big pharma and their powerhouse of lobbyists could help push this along. The pharmaceutical industry feels that they would be able to get drugs approved faster if the agency was split, which has a direct impact on a pharmaceutical company’s bottom line.”
Ronholm agrees and expects more dialogue on the idea to happen in 2022. And even if it doesn’t, the Reagan-Udall Foundation report revealed a lot of organizational failures that validated what many food safety experts have been saying for years, and he believes FDA will take many of the ideas for betterment into consideration, which would have a huge impact on food safety going forward.
Money Matters
Currently, nearly half of FDA’s budget is funded by user fees levied on industry members, and nearly all those user fees are drawn from drug, not food producers. Specifically, according to FDA, food regulation activities account for 18% of FDA’s budget, but only 1% of that funding comes from food industry user fees, while 65% of the funding comes from the drug industry. The rest comes from the Treasury.
Therefore, LaRae-Perez says that migrating food safety regulation to a new agency would require Congress to allocate much more than half of the current FDA Treasury funding to a new food safety agency, or the new food safety agency would have to start imposing significant user fees on food producers to fill the gap.
Many argue that the bigger and probably more important issue, which needs to be addressed whether the agency is split or not, is increasing FDA’s budget. “Currently, the FDA does not have the resources to inspect every food facility every two years as required by the FDA,” Williams says. “Realistically, this is done every three to five years. If the agency does get split, I think we need to understand the impact this could have on the FDA’s budget, as some shared resources may not be able to be shared anymore after the split. This could have a serious impact on both the food and drug industries, as well as consumers.”
Leave a Reply