FDA Commissioner announces structural review

The FDA will be going under the microscope...

US Food and Drug Administration (FDA) Commissioner Robert M. Califf has released a statement confirming an evaluation of the FDA’s programmes, including how the administration is governed.

“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,” Califf said in a statement.

One are of evaluation which will no doubt interest the US food and beverage industry is that of the 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,” continued Califf.

“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.”

This evaluation has been suggested by many in the industry for some time, but it could still take a little while before any meaningful change is delivered.

“The Reagan-Udall Foundation, an independent partner organisation 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 the Center for Tobacco Products (CTP), to the agency within 60 business days of initiation,” confirmed Califf.

“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.