FDA admits delays in response to formula shortage

FDA admits delays in response to formula shortage

By MATTHEW PERRONE – AP Health Writer

WASHINGTON (AP) — The Food and Drug Administration acknowledged on Tuesday that its response to the U.S. infant formula shortage has been slowed by delays in processing a whistleblower complaint and test samples. of the largest infant formula factory in the country.

A 10-page report from the agency offers its first official account of the factors that led to the current shortage, which has forced the United States to airlift millions of pounds of powdered formula from overseas.

The review focused on several key agency issues, including outdated data-sharing systems, inadequate staffing and training among its food inspectors, and poor visibility into formula supply chains and manufacturing procedures.

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

Califf said the FDA will seek new authority to compel companies to provide key information.

A consumer advocate said the assessment doesn’t go far enough to fix the problems.

“This internal assessment treats the symptoms of the disease rather than offering a cure,” Scott Faber of the Environmental Working Group said in a statement. “Nothing in this assessment addresses the fragmented leadership structure that led to critical communication failures.”

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

A company whistleblower had tried to notify the FDA of the plant’s problems in September 2021, but government inspectors didn’t investigate the complaints until February after four infants fell ill, resulting in two deaths. . The FDA is still investigating the links between these diseases and the formula.

The FDA previously told Congress that senior agency officials were not made aware of the complaint until February due to mail delays and an inability to escalate the Abbott employee’s allegations. . The new report says the FDA’s “inadequate processes and lack of clarity around whistleblower complaints” may have delayed dispatching inspectors to the factory.

“Whistleblower complaints come to the agency in different ways, from many different sources,” said Dr. Steven Solomon, an FDA veterinary medicine officer who oversaw the review. “One of the steps we’ve already taken is to make sure that regardless of how they come into the agency, they’re sorted and escalated to the right levels of management.”

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

The FDA also noted that it had to postpone its initial inspection of Abbott’s plant due to cases of COVID-19 among company personnel. This delay added to earlier missed inspections because the agency withdrew its inspectors from the field during the pandemic.

The report concluded by listing new resources Congress should authorize to improve infant formula inspections and standards, including:

— Increased funding and hiring powers to recruit experts in the Food Division of the FDA;

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

— New authority to require manufacturers to submit samples and records on manufacturing supply chains, manufacturing quality and safety.

U.S. infant formula inventories have improved, reaching inventory levels above 80% last week, according to IRI, a market research firm. That’s up from a low of 69% in mid-July. The United States has imported the equivalent of more than 80 million bottles of formula since May, according to White House figures, and the Biden administration is working to help foreign manufacturers stay in the market at long term to diversify the offer.

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

Follow Matthew Perrone on Twitter: @AP_FDAwriter.

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

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