FDA acknowledges delays in response to infant formula shortages

WASHINGTON — The Food and Drug Administration acknowledged Tuesday that it responded to the U.S lack of baby formula was slowed by delays in processing a whistleblower complaint and test samples from the nation’s largest formula plant.

The agency’s 10-page report offers the first official account of the factors that led to the persistent deficit, which forced the U.S. to carry millions of pounds powdered formula from abroad.

The review focused on several key issues at the agency, including outdated data sharing systems, inadequate staffing and training of food inspectors, and poor visibility into formula supply chains and manufacturing procedures.

“When it comes to things that are critical to health care, 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’re going to have a real problem,” FDA Commissioner Robert Califf said. . Associated Press in an interview. “That’s pretty much what happened here.”

Calif said the FDA will seek new powers to force companies to hand over key information.

One consumer advocate said the assessment doesn’t go far enough to address the concerns.

“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 breakdowns.”

The FDA report was overseen by a senior official who interviewed dozens of agency employees. It comes nearly eight months after the FDA shut down Abbott’s Michigan plant security issuesrapidly reducing domestic production within highly concentrated formula industry.

A company whistleblower tried to alert the FDA about problems at the plant in September 2021, but government inspectors didn’t investigate the complaint until February, after four infants became ill, leading to two deaths. The FDA is still investigating the link between these illnesses and the formula.

FDA earlier said Congress that top agency officials did not learn of the complaint until February because of mail delays and a failure to escalate the allegations against the Abbott employee. The new report says that “inadequate FDA processes and a lack of clarity related to whistleblower complaints” may have delayed inspectors from coming to the plant.

“Whistleblower complaints come to the agency in a variety of ways and from a variety of sources,” said Dr. Steven Solomon, the FDA’s veterinary medicine officer who led the review. “One of the things we’ve already started is to make sure that whether or not they come into the agency, they’re triaged and escalated to the right level of management.”

FDA inspectors collected bacteria samples from the plant for testing, but shipping problems with “third-party delivery companies” delayed the results, the report said. The FDA has also faced challenges ramping up its testing capabilities for cronobacter, a rare but potentially deadly bacteria that has been repeatedly linked to outbreaks in infant formula.

The FDA also noted that it had to postpone an initial inspection of the Abbott plant because of cases of COVID-19 among the company’s personnel. This delay occurred in addition to previously missed inspections because the agency inspectors pulled him out from the field during the pandemic.

The report concludes by listing new resources that Congress will need to authorize to improve infant formula inspections and standards, including:

— Increased funding and hiring authority to recruit experts to the FDA’s Food Division;

— Improved information technology for sharing data on FDA inspections, consumer complaints, and test results;

— New powers to compel manufacturers to hand over samples and records about manufacturing supply chains, quality and manufacturing safety.

U.S. infant formula inventories are improving, rising more than 80% last week, according to IRI, a market research firm. That’s up from a low of 69% in mid-July. The U.S. has imported more than 80 million bottles of formula since May, according to the White House, and the Biden administration is working to help foreign producers remain on the market long-term supply diversification.

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

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Follow Matthew Perrone on Twitter: @AP_FDAwriter.

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