FDA Commissioner Dr. Robert Califf told CNN that there was no problem or person responsible for the crisis.
“There are a number of things, any of which would probably have been something to consider but not major, but when the holes line up, that’s when major problems occur,” he said.
The FDA’s investigation into bacterial contamination in formula in January ultimately resulted in recalls of many popular brands, forced the closure of a major manufacturing plant and exacerbated shortages caused by supply chain disruptions.
Califf announced earlier this year that it had appointed an agency veteran to lead the internal review, the results of which were released on Tuesday. He found that delays, lack of procedures, and limits on FDA authority shaped the response.
Based on dozens of interviews with 61 employees, the 10-page assessment highlights the top areas where improvement is needed: 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 the Cronobacter bacteria, which is found in infant formula; and a better understanding of the formula industry.
The baby formula shortage has eased, but it’s not over. Numbers from market research firm IRI show that about 21% of powdered infant formula was out of stock in the first week of September, roughly double the stock-out rate for powdered infant formula in January, before the recall.
“Like an airplane taking off, we are gaining altitude, but we are not there yet. So it’s much better than it was, but we still have a long way to go,” Califf told CNN.
The report says that no single action can explain what happened; “Rather, the report identifies a confluence of systemic vulnerabilities” that show the need to modernize the agency and invest in better knowledge and tools to address public health threats.
Among the shortcomings highlighted in the report:
It says the FDA failed to handle a whistleblower complaint related to contamination at Abbott Nutrition’s manufacturing facility in Sturgis, Michigan. The complaint was sent to the agency in October 2021, but it took the agency two more months to interview the complainant, who was a former Abbott employee.
The report says that “inadequate processes and lack of clarity regarding whistleblower complaints” could have delayed the FDA’s response and describes how a complaint sent through the mail “and other delivery systems” was not delivered to recipients. The report urges the agency to provide staff training on 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 Abbott’s Michigan facility were “delayed in transit by third-party delivery companies.”
The lack of clear roles also hampered the response to formula shortages. The agency lacks procedures to coordinate such a complex response, which involved its Office of Emergency Management, agency leadership, communications staff and subject matter experts.
The pandemic also played a role, according to the report. The Covid-19 cases at the Sturgis manufacturing plant delayed the FDA’s in-person response, and the agency does not have the power to force companies to share information remotely.
“The agency should continue its evaluation of the additional authorities, tools, and resources needed to remotely collect information from businesses during public health emergencies when in-person inspections may not be feasible,” the report says.
The agency said a lack of scientific knowledge about Cronobacter also hampered its investigation.
Cronobacter infections, which can be serious and even deadly in infants, are not on the nationally notifiable list. Only one state, Minnesota, requires doctors to report Cronobacter infections to state and federal health officials. As a result, the true death toll of the disease in the US is unknown.
The list is controlled by state health officials, and the process to get a disease on the list is lengthy and sometimes contentious.
The report urges the FDA to work with investigators 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 by outside experts is still ongoing. The inspector general for the Department of Health and Human Services also released a review of the agency’s handling of the infant formula crisis that is due in 2023.
“The situation at the Abbott Sturgis facility has highlighted how little authority the FDA has to force many companies to ‘do the right thing’ without intervention,” he said in the statement.
“Rest assured, we are committed to making the necessary changes to help us avoid future supply shortages and ensure that parents and caregivers have access to safe and nutritious infant formula when and where they need it.”
CNN’s Jamie Gumbrecht contributed to this report.