By Matthew Byron, Associated Press health writer
Washington (AFP) – The Food and Drug Administration admitted Tuesday that its response to the United States lack of infant formula It was slowed by delays in processing a whistleblower complaint and testing samples from the nation’s largest formula manufacturer.
A 10-page report from the agency provides its first official account of the factors that led to the persistent shortage, which has forced the United States to move millions of pounds. Powder formula from the outside.
The review focused on several major problems at the agency, including outdated data-sharing systems, inadequate staffing and training among food inspectors, and poor visibility into formula supply chains and manufacturing procedures.
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Food and Drug Administration Commissioner Robert Califf told The Associated Press in an interview. “That’s pretty much what happened here.”
Califf said the Food and Drug Administration will seek new authority to compel companies to turn over key information.
One consumer advocate said the assessment isn’t enough to fix the problems.
“This internal evaluation treats the symptoms of the disease rather than providing a cure,” Scott Faber of the Environmental Working Group said in a statement. “Nothing in this assessment addresses the fragmented command structure that has led to serious communication failures.”
The FDA report was overseen by a senior official who interviewed dozens of agency employees. This comes nearly eight months after the FDA shut down the Abbott plant in Michigan due to Safety Concernsresulting in domestic production rapidly reduced within Highly concentrated formula industry.
A company whistleblower tried to warn the Food and Drug Administration of problems at the plant in September 2021, but government inspectors didn’t investigate complaints until February after four children fell ill, resulting in two deaths. The Food and Drug Administration is still investigating the links between those diseases and the formula.
Formerly FDA Congress said That senior agency officials did not learn of the complaint until February due to mail delays and the failure to escalate the Abbott employee’s allegations. The new report said “inadequate FDA processes and lack of clarity regarding whistleblower complaints” may have delayed inspectors’ access to the plant.
“Whistleblower complaints come to the agency in many different ways, and from different sources,” said Dr. Stephen Solomon, the FDA veterinary officer who oversaw the review. “One of the actions we’ve already taken is to make sure that regardless of their access to the agency, they are categorized and escalated to the right levels of leadership.”
Food and Drug Administration inspectors collected bacterial samples from the plant for testing, but shipping issues by “third-party delivery companies” delayed the results, according to the report. The FDA has also faced challenges in increasing its ability to test for bacterium globulus, a rare but deadly bacterium that has been repeatedly linked to outbreaks in infant formula.
The FDA also indicated that it had to reschedule the initial inspection of the Abbott plant due to COVID-19 cases among company employees. This delay came on top of earlier missed inspections because the agency withdrew its inspectors from the field during the pandemic.
The report concluded by listing the new resources that Congress will need to authorize to improve infant formula inspections and standards, including:
Increase funding and staffing authority to recruit experts for the Food and Drug Administration’s Food Division;
– Improving IT to share data about FDA inspections, consumer complaints, and test results;
A new authority to compel manufacturers to submit samples and records of manufacturing supply chains, quality and safety of manufacturing.
US infant formula stocks have improved, with inventory rates exceeding 80% last week, according to market research firm IRI. 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 the formula since May, according to White House figures, and the Biden administration is working to help. Foreign manufacturers remain in the market In the long run to diversify the offer.
Cliff commissioned a separate external review of 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 Heaney, who led the agency during the final years of the Clinton administration.
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