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.
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