In February 2022, I rejoined the U.S. Food and Drug Administration as Commissioner of Food and Drugs, having served in the role five years earlier. Since my return, the agency has taken many significant actions that benefit the public health. Yet at the same time, the agency has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations, prompting me to take a closer look at how we do business.
As a result, for two of the agency’s key programs, I have commissioned external agency experts to conduct a comprehensive evaluation for:
The agency’s Human Foods Program, including the Office of Food Response and Policy (OFPR), Center for Food Safety and Applied Nutrition (CFSAN), as well as relevant parts of the Office of Regulatory Affairs (ORA)
While America’s food supply is safe, and our Foods program experts have significantly contributed to the availability of more nutritious food options for consumers, the program has been stressed by the increasing diversity and complexity of the nation’s food systems and supply chain. Fundamental questions about the structure, function, funding and leadership need to be addressed. The agency’s inspectional activities related to the program also need to be evaluated, particularly in light of stresses related to the COVID-19 pandemic.
The Center for Tobacco Products (CTP)
Just over 13 years ago, Congress tasked the FDA with regulating tobacco products. In the ensuing years, we have made important progress and reached regulatory decisions on a broad array of millions of products. But even greater challenges lie ahead as we determine how the agency will navigate complex policy issues and determine enforcement activities for an increasing number of novel products that could potentially have significant consequences for public health. CTP will continue its important work during the evaluation, including review pending applications and take enforcement actions as needed.
I have discussed this evaluation with the relevant leadership of these centers and offices, all of whom welcome the opportunity to work towards organizational excellence. Each of these areas are full of hardworking and talented individuals who have dedicated their careers to working across a variety of scientific, policy, legal and administrative activities. FDA employees deserve the best support possible so they can fulfill their strong commitment to public health – and the American public that we serve.
The Reagan-Udall Foundation, an independent partner organization for the agency, will be working with an external group of experts on the evaluation. The Foundation will report its findings, including an initial assessment of the processes and procedures, resourcing, and organizational structure for the Foods program and CTP, to the agency within 60 business days of initiation. It may take some time to implement any recommended changes, but I am committed to addressing them and communicating them to the public in a timely manner. It is my belief that this effort will continue strengthening the FDA and better position the agency to deal with the many immediate public health issues we are facing, while preparing for the many scientific challenges and fascinating opportunities of the future.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.