A shakeup of the chain of command at the FDA may be coming, but the beginning of the release of details is at least 60 working days away.
FDA Commissioner Dr. Robert Califf was unavailable for immediate comment this afternoon but a statement released by him says the agency has hired an outside company to review the agency’s internal processes to find better ways to get things done.
“We have engaged the Reagan Udall Foundation, an independent partner organization for the agency that will be working with an external group of experts on the evaluation. We anticipate that the evaluation team for Reagan Udall will include former FDA executives with deep knowledge and organizational experience to lead the reviews,” according to a statement Califf’s office provided to Food Safety News.
The Reagan-Udall Foundation for the Food and Drug Administration is an independent 501(c)(3) organization created by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.”
The review action comes after members of Congress grilled Califf and other executives in the hierarchy at the Food and Drug Administration regarding what was described at the congressional hearing as the agency’s fumbling response to a deadly outbreak on infections associated with infant formula.
One complaint from congressional members has been that there is not a clear chain of command at the agency. There is no deputy commissioner for food who reports directly to Calif and there are two administrators who are each responsible for some of the agency’s food safety programs, but neither reports to the other in a traditional chain of command fashion.
“Fundamental questions about the structure, function, funding and leadership need to be addressed,” according to Califf’s written statement released today. “The agency’s inspectional activities related to the (food) program also need to be evaluated, particularly in light of stresses related to the COVID-19 pandemic.”
During the May 25 congressional hearing Rep. Rosa Delauro, D-CT, asked why it took FDA several months after first being notified of an infant infection related to infant formula manufactured by Abbott Nutrition at its Sturgis, MI, plant to take definitive action. That notification came from Minnesota officials in September 2021 when Janet Woodcock was acting commissioner for the FDA. In October 2021 an extensive whistle blower document from a former employee of the Sturgis plant was sent to several FDA officials. It detailed multiple food safety breaches at the plant, but the document was not forwarded to key administrators at the FDA. Ultimately the FDA’s inspection found the vast majority of the whistle blower’s claims to be true.
It was not until late December 2021 that the FDA interviewed the whistle blower. The agency did not begin investigating the situation until January 2022 when three more babies were found to be infected, with one of them having died.
Commissioner Calif was sworn in as the leader of the FDA on Feb, 17, the same day that Abbott recalled infant formula, including the extremely popular Similac brand used by many WIC programs. That same day the plant was closed down for inspection and investigation.
Califf and others at the FDA have been challenged for not releasing details about the situation with them citing “ongoing investigation” status as the reason behind the silence. They have also been blamed for the infant formula shortage that has plagued parents, leaving them to drive for hours at a time to find food for their babies.