Editor’s note: FDA Commissioner Robert M. Califf gave a speech in June at the FDLI’s annual conference. Here are excerpts from his prepared remarks that focused on food safety.
“One issue that has come to the fore, highlighted by recent infant formula supply challenges, is the need to properly fund, revamp and restructure our feeding program.
“I want to be clear: the shortage of infant formula on our shelves was multifactorial, including the loss of focus on quality by a large company, market concentration, supply chain resilience issues and the insufficient federal authorities to ensure vital supply chains. However, the crisis also reveals shortcomings at the FDA, including structural and organizational shortcomings, process inadequacies, communication barriers, technological inadequacies, chronic underfunding and, in some cases, a lack of authority. of Congress to allow us to do what is necessary to provide adequate service. provision of safe and nutritious infant formula.
“We are currently conducting both a targeted infant formula after action review and a comprehensive review of the entire feeding program to determine the best course of action. And when these reviews are completed, we will make the necessary changes that we are able 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. This law has made a dramatic difference on the medical products side, providing the FDA with significant resources and changes in regulatory authority that have strengthened our ability to support innovation without sacrificing our standards of safety and efficiency.
“It’s time for the food side to receive a similar blow in the arm. The needs are clear, significant and span the breadth 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 organization that provides opportunities for education, training, publications, and professional engagement in the area of food law and drugs.
As a neutral convener, FDLI provides a place for stakeholders to inform innovative public policies, laws and regulations.
The scope of FDLI covers all industries regulated by the United States Food and Drug Administration (FDA) and related agencies and authorities in the United States and around the world, including drugs, medical devices, biological products, foods, dietary supplements, cosmetics, veterinary products, tobacco and cannabis-derived products. some products.
The FDLI community includes manufacturers, distributors, law firms, consultants, academics, government employees, non-profit organizations, and students. Collectively, the group of stakeholders engaged with FDLI numbers over 30,000 people.
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