A wide-ranging report into the practices, culture and structure of US regulator The Food and Drug Administration (FDA) has called for change at the organisation.

The report was commissioned by FDA Commissioner Robert Califf following the food security scare linked to a shortage of infant-nutrition products in US supermarkets in the wake of a contamination-linked facility closure at major baby-formula manufacturer Abbott Laboratories.
That closure lasted for several months and the shortage led to the Biden administration invoking emergency measures to facilitate the shipping in of replacement product from abroad.

The external report follows an internal review into the crisis published in September which found the FDA made mistakes in the way it responded to the infant-formula crisis.

That review pointed to “systemic vulnerabilities” at the FDA as it investigated reports of Cronobacter bacteria-contaminated product at Abbott’s plant in Sturgis, Michigan.

Following the internal probe, Califf asked the ReaganUdall Foundation to convene an independent panel to conduct a comprehensive review of the FDA Human Foods Program with the aim of strengthening its regulatory role.

The panel’s findings have now been published in a 51-page report. It said the FDA’s leadership and culture must be restructured to prevent future illness outbreaks and to better respond to food safety crises.

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The “lack of a single, clearly identified person” to lead the programme has led to a culture of “constant turmoil” at the agency, the report said.

It added: “To strengthen the FDA Human Foods Program as a premier public health regulator, necessary resources must be provided to ensure the agency has the best technology, expert staff, and unrivalled infrastructure to advance its mission. Sufficient authority to fulfil its mission effectively is required. Leadership must embrace a proactive, prevention-driven strategy that is action-oriented and fosters effective and efficient decision-making.”

Scenarios suggested for FDA reform

However, the report stopped short of recommending specific steps to take, instead offering several possible scenarios such as creating a separate food agency within the US Department of Health and Human Services, putting the FDA commissioner directly in charge of the foods program or creating a deputy commissioner for foods.

Responding to the report, Califf said he would consider which changes to make after reviewing the report and consulting with experts inside and outside the agency. He said he would report back early next year.

“Although we have not yet had an opportunity to review the full report in depth, it does provide significant observations and options for the agency’s consideration, reflecting important and diverse perspectives, which will be carefully considered,” he said.

Califf suggested the September review of the agency’s infant-formula supply chain response has already resulted in “noticeable improvements” in its operations.

He said he will oversee the food programme until a determination is made on how the FDA will strengthen and modernise the division.

“I will be fully engaged to ensure that the program comes out of this transition with the resources, tools and visibility it warrants given how critical its work is to every American,” he said.

The FDA is responsible for overseeing the safety of 78% of the US human food supply and all animal feed.