In a presentation to the Food and Drug Law Institute, Commissioner of the FDA, Dr. Robert M. Califf, commented on the factors resulting in the shortage of infant formula in the U.S. The event resulted in the need to airfreight product into the U.S. using military airlift capacity. Shortages have caused extensive inconvenience and anxiety for parents and political fallout for the Administration. 

Califf stated, “I want to be clear:  the infant formula shortage on our shelves was multifactorial, including a loss of focus on quality by a major company, market concentration, supply chain resilience issues and inadequate federal authorities to assure vital supply chains.”  To his credit, Dr. Califf conceded, “The crisis also revealed shortcomings at the FDA, including structural and organizational deficiencies, process insufficiencies, communication barriers, technological inadequacies, chronic underfunding and in some cases, a lack of Congressional authority to allow us to do what is needed to assure an adequate supply of safe and nutritious infant formula.”

Dr. Califf advocated for additional Congressional action based on the 21st Century Cures Act that enabled FDA to make changes in regulatory authority applied to drugs.