UPDATED — This version of this story includes quotes from Commissioner Robert Califf and U.S. Rep. Rosa Delauro.
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 told Food Safety News today that the agency has hired an outside company to review the agency’s internal processes to find better ways to get things done.
“It’s good to have someone who isn’t inside the organization look at things sometimes. It’s not revamping for the past, it’s for the future … it’s good to have independent eyes, not just from the inside,” he said.
“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,” Califf said.
U.S. Rep. Rosa Delauro, who closely watches the FDA, is in agreement with Califf on that point.
“Food safety is a second-class citizen at the FDA. The appointment of an outside, independent expert to conduct a thorough review of the food program is welcome, and will supplement the HHS OIG report that I called for at the beginning of the infant formula crisis,” Rep. DeLauro told Food Safety News.
“It is imperative that any internal or external report that involves a review of the food program is made available to the public for comment.
“I expect full transparency and extensive stakeholder engagement.”
Califf wouldn’t pin the need for a review solely on the infant formula crisis that has plagued the country for months. He did, however say there are multiple events and needs within the FDA that require attention.
Some of those situations go back to 2015-17 when he was commissioner of the agency. At that time he felt the FDA was underfunded and he still does, “but it was the end of the Obama Administration and not a good time to start new things.”
The Reagan Udall Foundation, which is an independent group with FDA affiliations, will be doing the review, which will take 60 business days.
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 of 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.
Califf told Food Safety News that while Regan-Udall will look at chain of command issues, that’s not the only thing on the table. Everything is on the table.
“The right chain of command doesn’t necessarily address the impact of things across the board,” Califf said. “I’m not leaning one way of the other (on chain of command issues). At the end of the review we will know more. It’s not about the people at the FDA. They know what they are doing.”
Rep. DeLauro isn’t so sure about that. She is specific about her expectations for answers to chain of command questions.
“As the infant formula crisis highlighted, we cannot afford to continue along this path where bad actors are more concerned with skirting accountability than prioritizing the health and safety of American families.
“In the meantime, I renew my call to better food safety at the FDA immediately by appointing an empowered Deputy Commissioner for Foods, who is an expert in food safety, to oversee all of FDA’s food program,” DeLauro told Food Safety News.
Prior to his interview with Food Safety News, Califf released a statement with some similar points.
“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 a May 25 congressional hearing Rep. 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 for FDA to begin an investigation.
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 all 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.
Califf stood by his work at the FDA in the past six months. He said there have been many issues to deal with and he and agency staff have been working hard to address all of the situations.
As for his tenure so far and his leadership as the new review gets underway, Califf said he is prepared to do his duty.
“In the FDA the buck stops with me, but as we in government are all aware there are many bosses. I report to the Secretary of Health and Human Services and we all report to the oversight of Congress.”
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