Restructuring the Food Program at FDA

Editor’s Note: FDA Commissioner Robert M. Califf delivered remarks in June to the FDLI Annual Conference. Here are excerpts from his prepared remarks that addressed food safety.

“One issue that’s been front and center, highlighted by the recent challenges related to the supply of infant formula, is the need to adequately fund, revamp and restructure our food program. 

“I want to be clear: the infant formula shortage on our shelves was multifactorial, including loss of focus on quality by a major company, market concentration, supply chain resilience issues, and inadequate federal authorities to assure vital supply chains.  However, the crisis also reveals 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.   

“We are currently conducting both a focused after-action review on infant formula and a comprehensive review of the entire food program to determine the best course of action. And when these reviews are completed, we will make whatever changes are necessary and that we have the ability to do.  

“But other changes will require congressional action.  A good model is the 21st Century Cures legislation, passed by Congress a few years ago.  That law made a dramatic difference on the medical product side, providing FDA with important resources and changes in regulatory authority that strengthened our ability to support innovation without sacrificing our standards of safety and efficacy. 

“It’s time that the food side got a similar shot in the arm. The needs are clear, significant, and run the expanse of our food safety work, from more inspectors to more funding to better data and technology. “

FDLI is the Food and Drug Law Institute, founded in 1949. It is a nonprofit membership organization that offers education, training, publications, and professional engagement opportunities in the field of food and drug law.

As a neutral convener, FDLI provides a venue for stakeholders to inform innovative public policy, law, and regulation.

FDLI’s scope covers all industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities in the U.S. and globally, including drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products.

The FDLI community includes manufacturers, distributors, law firms, consultants, academics, government employees, non-profits, and students. Collectively, the stakeholder group engaged with FDLI is 30,000+ individuals.

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