Internal FDA Report on Infant Formula Crisis Describes Response Shortcomings

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An internal investigation of the Food and Drug Administration’s actions in the run-up to the infant feeding crisis reveals that a combination of human error, outdated technology, and poor communication and accountability among an already worn-out food staff have all contributed to a perfect storm of problems that the supply shortage worsened.

The problem was only exacerbated by the lack of a robust FDA mandate to comply with the strong weapons industry players, the review found.

In more than 40 interviews with more than 60 FDA employees and executives who were “directly involved in the events that occurred,” the review found that “inadequate processes and lack of clarity” was the agency’s response to contamination issues at its plant. Abbott, an infant formula manufacturer in Sturgis, has slowed down. , Michigan; and that at various times critical information has slipped through the cracks of agency consciousness.

In a statement, FDA chief Robert Califf said the agency had no power to force the hand of the industry.

“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,” Califf said.

The internal review echoed that sentiment: “a confluence of systemic vulnerabilities” here demonstrated the need for increased investment in modern tools and technology to prepare for future public health challenges.

The FDA’s limited mandate and resources prevent them from managing “supply chain problems and shortages of critical food items,” the review said, especially when it comes to a supply chain like that of baby food, which has already been under pressure from the regulatory environment. Covid pandemic — and which further accentuated Abbott’s recall and pause in production.

The review also noted that the contamination and disease at the heart of Abbott’s mass shutdown, Cronobacter sakazakii, is “poorly understood” and lacks thorough federal oversight — and that those “scientific gaps” in understanding Cronobacter “are the hindered the FDA’s response to the incident.”

The discovery of Cronobacter in Abbott’s Sturgis plant prompted a massive voluntary recall of the formula in February after four babies who had taken Abbott’s formula contracted a Cronobacter infection. Two of the babies subsequently died, although Abbott claims there is no conclusive evidence that the formula caused the teething problems, as none of the Cronobacter strains found in their factory matched the two samples genetically sequenced from the sick babies. .

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Ultimately, it was Cronobacter’s combined findings at Abbott’s plant — along with a pattern of serious operational failures and consumer complaints — that led to its closure.

In a statement to TBEN News regarding the internal review, an Abbott spokesperson said they will “continue to raise the bar” for their formula’s regulatory requirements “by working with FDA and industry partners to improve the safety and processes of their product.” to further promote infant feeding.”

Abbott’s shutdown bounced back across the country, exacerbating the supply shortage and forcing families to look for alternatives in the hyper-concentrated formula market.

FILE PHOTO: A baby food cabinet is seen in a Walmart store in Raleigh, North Carolina, USA on June 2, 2022. Photo taken on June 2, 2022. REUTERS/Arriana Mclymore/File Photo

Staff/Reuters

The FDA’s Califf has previously noted some of the points outlined in the report released Tuesday that the response has been “too slow,” with “decisions being sub-optimal along the way,” while warning FDA staff “very tired, overworked”. the agency’s food safety arm is underfunded.

Califf has also previously pointed to the FDA’s lack of authority to “force companies to give us information,” instead pointing the finger at Abbott’s failure to be candid about the problems at their factory.

Critics of the FDA’s response have previously pointed out that there was a brewing problem in the formula market before Abbott’s shutdown — and that the administration had plenty of warning signs, both about the supply chain pandemic and Abbott’s long-standing quality control issues. before things hit a climax. boiling point this spring.

But this report contains several new details about repeated inaccuracies in the response, including critical flaws in the delivery system and the need for better communication with staff at the FDA.

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The review says the FDA found that some samples taken from Abbott’s Sturgis plant after raising concerns about contamination “were delayed in transportation by third-party delivery companies.”

The review comes after FDA leadership revealed this spring that a whistleblower complaint from a former Abbott employee describing a “litany of violations” at the Sturgis plant had remained in limbo for months. That complaint was sent to the FDA last October, but wasn’t delivered, seen, or escalated until four months later — because of what the FDA has said was “an isolated failure in the FDA’s mailroom, likely due to COVID-19.” staff issues.”

The new internal review now says that such gaps in coordination between systems (although accountability here to a “third party”) “make it difficult for the agency to match related submissions and identify rapidly emerging security and quality issues.”

“FDA should review procedures for shipping and testing samples sent to regulatory labs and consider making changes to analytical capability and capability, and ways to enable immediate notification and escalation of analytical results for significant threats. for public health,” the review said.

The review adds that the agency is “collecting an inventory of every point of access for consumers, whistleblowers, other government agencies, clinicians and other members of the public to inform the FDA of their concerns about product safety and quality,” which will help. to “streamline” safety issues to “quickly assess emerging safety signals”.

The internal review ultimately identified five key findings for the FDA to improve upon, including the need for more modern data technology that “enables real-time access and exchange of data for all people involved in the response.”

“The lack of coordination between systems makes it difficult for the agency to connect related submissions and quickly identify new safety and quality issues,” the report says, and “inadequate processes and lack of clarity regarding whistleblower complaints can the FDA’s response to those complaints.”

The review also underscores the need for the FDA to optimize its emergency response capabilities to address multiple concurrent public emergencies. FDA “lacks procedures to facilitate this complex coordination of personnel in response activities beyond established food outbreak response policies and procedures,” the review said.

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The review also blames Covid infections at the manufacturing facility that “delayed the FDA’s personal response to complaints” related to Abbott’s Sturgis plant, and underscores the need to strengthen the FDA’s food workforce, including increased training, staffing. , equipment, funding and regulatory agencies “to fulfill the FDA’s mission.”

It also emphasizes the importance of closing knowledge and surveillance gaps about Cronobacter and translating that knowledge into “appropriate control measures”.

Those gaps in understanding “impeded the FDA’s response to the incident,” the review said.

It also noted that FDA oversight should focus on accountability within the infant formula industry, which uses “outdated data-tracking technology and practices that can cause delays in collecting critical information needed to extend the scope.” of executing and defining recalls.”

In addition, the FDA lacks robust enforcement stances to ensure companies adhere to the best practices of a strong food safety culture, the review said; manufacturers are not required to make Cronobacter isolates available to the FDA for sequencing and upload to the national database, which “limits the data available to help identify clusters of diseases and potential sources of contamination.” Without further authority, “it will be difficult for the FDA to identify early signs of potential safety concerns and work with manufacturers to mitigate these hazards.”

The FDA’s Califf had requested this review; the agency will “formulate working groups charged with implementing the recommendations,” and in a year’s time, the FDA’s progress on the above recommendations will be reviewed, the review said.

Meanwhile, the Office of Inspector General at the U.S. Department of Health and Human Services has also launched its own audit into how the FDA responded in the run-up to the recall and closure of Abbott’s Sturgis plant — and whether they were following proper recall protocol once deadly bacteria were detected in the plant. The OIG audit findings are expected sometime in FY 2023.

The FDA says they are working with the OIG and “looks forward” to their “findings and recommendations.”

Anne Flaherty of TBEN News contributed to this report.

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