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FDA report details agency trial and error in infant formula investigation that hampered response



CNN

A perfect storm of ‘systemic vulnerabilities’ at the U.S. Food and Drug Administration unfolded as the agency investigated tainted baby formula and slowed its response to worsening formula shortages, according to a internal review.

FDA Commissioner Dr. Robert Califf told CNN there was no single issue or person responsible for the crisis.

“There are a number of things, each of which would probably have been something worth noting but not important, but when the holes line up, and that’s where the big issues come in,” he said. declared.

The FDA investigation into bacterial contamination of formulas in January ultimately resulted in the recall 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 findings of which were published 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 key areas where improvement is needed: the FDA needs more modern technology; more personnel, training and equipment; updated emergency response systems that can handle more than one incident at a time; more scientific knowledge about the Cronobacter bacteria found in infant formula; and a better understanding of the formula industry.

“Put simply, if the FDA is to do more, it needs more,” Dr. Steven Solomon, director of the FDA’s Center for Veterinary Medicine, which led the review, said in a statement. “As the agency assesses its workforce needs related to infant formula regulation and oversight, we recommend that it use the appropriations process to help secure authorities and resources required.”

The baby formula shortage has eased, but it’s not over. Figures from market research firm IRI show around 21% of powdered infant formula was out of stock in the first week of September, about double the stockout rate for powdered infant formula in January, before the recall.

“Like a plane taking off, we’re gaining altitude, but we’re not there yet. So it’s a lot better than before, but we still have a ways to go,” Califf told CNN.

The report says no action can explain what happened; “Rather, the report identifies a confluence of systemic vulnerabilities” that point to the need to modernize the agency and invest in better expertise and tools to deal with public health threats.

Among the shortcomings highlighted in the report:

It says the FDA fumbled in handling 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 another two months to interview the whistleblower, who was a former Abbott employee.

The report states that “inadequate processes and a lack of clarity related to whistleblower complaints” may have delayed the FDA’s response and describes how a complaint sent by mail “and other delivery systems” did not not been transmitted to those to whom it was addressed. The report urges the agency to provide training to staff on how to escalate complaints and review its mail delivery procedures.

It also says the agency should assess procedures for shipping and testing samples sent to regulatory labs because some samples from Abbott’s Michigan facility have been “delayed in transit by third-party delivery companies.” .

The lack of clear roles has also hampered the response to the formula shortage. The agency lacks procedures for coordinating such a complex response, which involved its emergency management office, agency leadership, communications staff and subject matter experts.

The pandemic also played a role, according to the report. Covid-19 cases at the Sturgis manufacturing plant have delayed the FDA’s in-person response, and the agency does not have the authority to compel companies to share information remotely.

“The agency should continue its assessment of additional authorities, tools, and resources needed to remotely gather information from businesses during public health emergencies when in-person inspections may not be possible,” the report said.

The agency said a lack of scientific knowledge about Cronobacter also made its investigation more difficult.

Cronobacter infections, which can be serious and even fatal for babies, are not on the list of notifiable diseases at the national level. Only one state — Minnesota — requires doctors to report Cronobacter infections to state and federal health authorities. As a result, the true toll of the disease in the United States is unknown.

The list is controlled by state health officials, and the process of getting a disease listed is long and sometimes controversial.

The report calls on the FDA to work with researchers to fill gaps in the science and to consider resuming unannounced inspections at infant formula manufacturing facilities.

These conclusions 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 of the Department of Health and Human Services has also launched a review of the agency’s handling of the infant formula crisis expected in 2023.

In a statement, Califf said it agrees with the report’s findings and that while domestic formula makers are “stepping up” to increase production, in the long run the supply chain needs a greater diversity of manufacturers, new facilities and “commitment from these companies”. to consistently and continuously adhere to FDA quality and safety standards.

“The situation at the Abbott Sturgis facility has highlighted how little authority the FDA has to compel many companies to ‘do the right thing’ without interference,” he said in the press release.

“Rest assured that we are committed to implementing 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. need.”


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