A perfect storm of “systemic vulnerabilities” at the US Food and Drug Administration unfolded as the agency investigated contaminated baby formula and slowed its response to the worsening formula shortage, an internal review shows.
FDA Commissioner Dr. Robert Califf told News84Media that there wasn’t any one problem or person responsible for the crisis.
“There are a number of things, any one of which would probably have just been something to note but not of importance, but when the holes line up, and that’s when significant problems occur,” he said.
The FDA’s investigation of bacterial contamination in formula in January ultimately resulted in a recall of many popular brands, forced the shutdown of a major manufacturing plant and exacerbated shortages caused by supply chain disruptions.
Califf announced earlier this year that he had appointed an agency veteran to lead the internal review, the findings of which were released Tuesday. It found that delays, lack of procedures and limits on the FDA’s authority shaped the response.
Based on dozens of interviews with 61 employees, the 10-page assessment highlights major areas where it says improvement is needed: The FDA needs more modern technology; more staff, training and equipment; updated emergency response systems that can handle more than one incident at a time; more scientific knowledge about Cronobacter bacteria, which is found in infant formula; and a better understanding of the formula industry.
“Simply put, if the FDA is expected to do more, it needs more,” Dr. Steven Solomon, director of the FDA’s Center for Veterinary Medicine, who led the review, said in a statement. “As the agency evaluates its workforce needs related to infant formula regulation and oversight, we recommend that it utilize the appropriations process to help secure the authorities and resources needed.”
The baby formula shortage has eased, but it is not over. Numbers from market research firm IRI show that about 21% of powdered infant formula was out of stock the first week of September, roughly double the out-of-stock rate for powdered infant formula in January, prior to the recall.
“Like a plane taking off, we’re gaining altitude, but we’re not there yet. So it’s a lot better than it was, but we still have a ways to go,” Califf told News84Media.
The report says no single action can explain what happened; “rather the report identifies a confluence of systemic vulnerabilities” that shows the need to modernize the agency and invest in better expertise and tools to address public health threats.
Among the shortcomings highlighted in the report:
It says the FDA fumbled the handling of a whistleblower complaint related to the contamination at Abbott Nutrition’s manufacturing facility in Sturgis, Michigan. The complaint was sent to the agency in October 2021, but it took two more months for the agency to interview the whistleblower, who was a former Abbott employee.
The report says “inadequate processes and lack of clarity related to whistleblower complaints” might have delayed the FDA’s response and describes how a complaint sent by mail “and other delivery systems” was not delivered to those it was addressed to. The report urges the agency to provide training to staff about how to escalate complaints and review its mail delivery procedures.
It also says the agency should evaluate procedures for shipping and testing samples sent to regulatory labs, since some samples from the Abbott facility in Michigan were “delayed in transit by third party delivery companies.”
Lack of clear roles also hampered the response to the formula shortage. The agency lacks procedures for coordinating such an intricate response, which involved its Office of Emergency Management, agency leadership, communications staff and subject matter experts.
The pandemic also played a role, the report finds. Covid-19 cases at the Sturgis manufacturing plant delayed the FDA’s in-person response, and the agency does not have the power to compel companies to share information remotely.
“The agency should continue its evaluation of the additional authorities, tools and resources needed to remotely gather information from firms during public health emergencies when in-person inspections may not be feasible,” the report says.
The agency said that a lack of scientific knowledge about Cronobacter also made its investigation more difficult.
Cronobacter infections, which can be severe and even deadly to babies, are not on the list of nationally notifiable diseases. Only one state – Minnesota – requires doctors to report Cronobacter infections to state and federal health officials. As a result, the true toll of the disease in the US is unknown.
The list is controlled by state health officials, and the process for putting a disease on the list is a lengthy and sometimes contentious one.
The report calls for the FDA to work with researchers to address gaps in the science and to consider resuming unannounced inspections at infant formula manufacturing facilities.
These findings will not be the last word. A separate review of the agency’s food and tobacco programs – conducted by outside experts – is still ongoing. The inspector general for the Department of Health and Human Services has also launched a review of the agency’s handling of the infant formula crisis that’s due in 2023.
In a statementCaliff said that he agreed with the report’s findings and that although domestic formula manufacturers “stepped up” to increase production, in the long term, the supply chain needs greater diversity of manufacturers, new facilities and “a commitment by these companies to consistently and continuously adhere to the FDA’s quality and safety standards.”
“The situation at the Abbott Sturgis facility has highlighted just how little authority the FDA has to compel many companies to ‘do the right thing’ without intervention,” he said in the statement.
“Rest assured that we are committed to implementing the necessary changes to help us avoid future supply shortages and ensure parents and caregivers have access to safe and nutritious infant formula whenever and wherever they need it.”