WASHINGTON (AP) – The Food and Drug Administration acknowledged its response to US infant formula on Tuesday was slowed down by delays in processing a whistleblower complaint and test samples from the nation’s largest formula factory.
A 10-page report from the agency offers its first formal account of the factors that led to the ongoing shortage, which forced the United States to fly millions of pounds of formula powder from overseas.
The review focused on several key issues for the agency, including stale data sharing systems, inadequate staffing and training among its food inspectors, and poor visibility into formula supply chains and manufacturing procedures.
“For the 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 shortage you have a real problem,” said FDA Commissioner Robert Califf. to The Associated Press in an interview. “To a large extent that’s what happened here.”
Califf said the FDA will seek a new authority to compel companies to provide key information.
A consumer advocate said evaluation doesn’t go far enough to solve problems.
“This internal evaluation 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 has led to critical communication errors.”
The FDA report was overseen by a senior official who interviewed dozens of the agency’s staff members. It comes nearly eight months after the FDA closed the Abbott Michigan plant due to safety concernsrapidly reducing internal production within the highly concentrated formula industry.
A company whistleblower had tried to alert the FDA of problems at the plant in September 2021, but government inspectors did not investigate the complaints until February after four children fell ill, resulting in two deaths. The FDA is still studying the links between those diseases and the formula.
The FDA previously told Congress that senior agency officials did not learn of the complaint until February due to mail delays and the inability to escalate the allegations by employee Abbott. The new report said the FDA’s “inadequate processes and lack of clarity regarding whistleblower complaints” may have delayed the arrival of inspectors at the plant.
“Whistleblower complaints come to the agency in many different ways, from many different sources,” said Dr. Steven Solomon, an FDA veterinary medicine officer who oversaw the review. “One of the actions we have already taken is to make sure that no matter how they join the agency, they are selected and brought to the right levels of leadership.”
FDA inspectors collected bacterial samples from the facility for testing, but shipping issues from “third-party delivery companies” delayed the results, according to the report. The FDA has also faced challenges to increase 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 company personnel. That delay added to previous missed inspections because the agency withdrew its inspectors from the field during the pandemic.
The report concluded by listing the new resources Congress would need to authorize to improve infant formula inspections and standards, including:
– Increased funding and hiring authority to recruit experts in the FDA’s food division;
– Improved information technology to share data on FDA inspections, consumer complaints and test results;
– New authority to oblige manufacturers to deliver samples and records on production supply chains, production quality and safety.
According to IRI, a market research firm, U.S. infant formula stocks have improved, hitting inventory rates above 80% last week. This is up from a low of 69% in mid-July. The U.S. has imported the equivalent of more than 80 million bottles of infant formula since May, according to White House data, and the Biden administration is working to help foreign manufacturers stay on the market. in the long term to diversify the offer.
Califf commissioned a separate external review of the food division of the FDA citing “key questions about the structure, function, funding and leadership” of the program. That review is led by former FDA commissioner Dr. Jane Henney, who led the agency during the last few years of the Clinton administration.
Follow Matthew Perrone on Twitter: @AP_FDAwriter.
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