The FDA released a report on September 20 on its internal review of the agency’s actions related to early summer’s Cronobacter illness in infants, the Abbott infant formula manufacturing plant in Sturgis, Mich., “and confounding issues that led to a shortage of infant formulas.” Don’t expect any revelations in the below.
The investigation was spearheaded by Steven Solomon, director of the FDA’s Center for Veterinary Medicine. His report “is the result of information collected from more than 40 interviews with more than 60 FDA staff and leadership directly involved with the events that transpired.
“The report focuses on aspects of the response that are within the agency’s purview: other factors, including the limited number of infant formula manufacturers, needed improvements in the ingredient supply chain, and better control of product distribution, must be addressed by other external stakeholders.”
Solomon acknowledges up front that “limitations uncovered in our evaluation were magnified by the nature of infant formula as the sole source of nutrition for vulnerable populations,” although “the lessons learned can be applied across the entire FDA portfolio.”
The report contained nothing earth-shattering and nothing that appears to effect immediate change. But he identified five major areas of need:
- Modern information technology that allows for the access and exchange of data in real time to all the people involved in response.
- Sufficient staffing, training, equipment and regulatory authorities to fulfill the FDA’s mission.
- Updated emergency response systems that are capable of handling multiple public health emergencies occurring simultaneously.
- Increased scientific understanding about Cronobacter, its prevalence and natural habitat, and how this translates into appropriate control measures and oversight.
- Assessment of the infant formula industry, its preventive controls, food safety culture and preparedness to respond to events.
“One key finding … is that there is no single action to explain the events that occurred; rather the report identifies a confluence of systemic vulnerabilities that demonstrate the need to focus on continued modernization and investment in the expertise and tools needed to better anticipate and address future public health challenges in this area.
“This incident demonstrated the need for an integrated, multidisciplinary approach that included scientific, clinical, nutritional, analytical, and inspectional expertise; legal processes; supply chain and policy considerations; and resources to support this multidisciplinary work.
“The report also identifies several areas in which the FDA lacks specific authorities and resources. Simply put, if the FDA is expected to do more, it needs more. As the agency evaluates its workforce needs related to infant formula regulation and oversight, we recommend that it utilize the appropriations process to help secure the authorities and resources needed.”
