FDA admits delays in response to infant formula shortage

Published by
Peter Kavinsky

The Food and Drug Administration acknowledged on Tuesday that its response to the US infant formula shortage was delayed by delays in processing a whistleblower complaint and testing samples from the country’s largest formula factory.

A 10-page report from the agency offers its first formal account of the factors that led to the continued shortages, which forced the US to ship millions of pounds of powdered formula from abroad.

The review focused on several key issues at the regulatory agency, including outdated data-sharing systems, inadequate staff and training for food regulators, and poor visibility into formula supply chains and manufacturing procedures.

“For things that are critical to public health, if you don’t have some understanding of how all the pieces fit together, then when you get into a crisis or a shortage, you have a real problem,” said FDA Commissioner Robert Califf. Associated Press in an interview. “To a large extent, that is what happened here.”

Califf said the FDA will seek new authority to compel companies to hand over important information.

The report was overseen by a senior FDA official who interviewed dozens of agency officials. This comes nearly eight months after the FDA closed Abbott’s Michigan plant over safety concerns, quickly reducing domestic production in the highly concentrated formula industry.

A company whistleblower tried to alert the FDA about problems at the factory in September 2021, but government inspectors did not investigate the complaints until February after four babies became ill, resulting in two deaths. The FDA is still investigating the links between these diseases and the formula.

The FDA previously told Congress that top agency officials didn’t learn of the complaint until February because of postal delays and a failure to escalate the Abbott employee’s claims. The new report stated that the FDA’s “inadequate processes and lack of clarity regarding whistleblower complaints” may have delayed the arrival of inspectors at the plant.

“Complaints from whistleblowers come to the agency in many different ways, from many different sources,” said Dr. Steven Solomon, an FDA veterinary medicine official who oversaw the review. “One of the actions we’ve already taken is to ensure that regardless of how they enter the agency, they are screened and escalated to the right leadership levels.”

FDA inspectors collected bacterial samples from the plant for testing, but shipping issues by “third-party delivery companies” delayed results, according to the report. The FDA has also faced challenges in increasing its testing capacity for cronobacter, a rare but potentially deadly bacterium repeatedly linked to outbreaks in infant formula.

The FDA also noted that it had to reschedule its initial inspection of the Abbott plant due to cases of COVID-19 among the company’s employees. This delay came on top of previous missed inspections because the agency pulled its inspectors out of the field during the first year of the pandemic.

The report concluded by listing new features that Congress would need to authorize to improve infant formula inspections and standards, including:

— Increased funding and contracting authority to recruit experts for the FDA’s food division;

— Improved information technology to share data on FDA inspections, consumer complaints and test results;

— New authority to compel manufacturers to hand over samples and records on manufacturing supplies, quality and safety.

US infant formula inventories have improved in recent weeks, reaching stock rates above 80% last week, according to IRI, a market research firm. This is up from a low of 69% in mid-July. The US has imported the equivalent of more than 80 million bottles of formula since May, according to White House data, and the Biden administration is working to help foreign manufacturers stay in the market for the long term to diversify supply.

Califf commissioned a separate external review from the FDA’s food division citing “fundamental questions about the structure, function, funding and leadership” of the program. This review is being led by former FDA Commissioner Dr. Jane Henney, who led the agency during the final years of the Clinton administration.

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Follow Matthew Perrone on Twitter: @AP_FDAwriter.

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The Associated Press Department of Health and Science receives support from the Science Education Department of the Howard Hughes Medical Institute. The AP is solely responsible for all content.

Peter Kavinsky

Peter Kavinsky is the Executive Editor at cablefreetv.org

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