WASHINGTON (AP) — The Food and Drug Administration on Tuesday acknowledged its response to the U.S. infant formula shortage was slowed 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 shortages that have forced the US to ship millions of pounds of powdered formula overseas.
The review focused on several key issues facing the agency, including outdated data-sharing systems, insufficient staffing and training of food inspectors, and poor visibility into formula food supply chains and manufacturing processes.
“With things that are critical to public health, if you don’t understand how all the pieces fit together, then you have a real problem when you hit a crisis or shortage,” FDA Commissioner Robert Califf told The Associated Press interview. “To a large extent, that’s what happened here.”
Califf said the FDA will seek new authority to compel companies to release critical information.
A consumer advocate said the assessment doesn’t go far enough to fix the problems.
“This internal assessment addresses the symptoms of the disease rather than offering a cure,” Scott Faber of the Environmental Working Group said in a statement. “Nothing in this review addresses the fragmented leadership structure that has led to critical communication failures.”
The FDA report was overseen by a senior official who interviewed dozens of agency employees. It comes nearly eight months after the FDA shut Abbott’s Michigan plant over safety concerns and quickly cut domestic production within the highly concentrated formula industry.
A company whistleblower had tried to warn the FDA of problems at the facility 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 links between these diseases and the formula.
The FDA previously told Congress that senior agency officials only learned of the complaint in February because of delays in the mail and the Abbott employee’s allegations were not escalated. The new report said the FDA’s “inadequate procedures and lack of clarity regarding whistleblower complaints” may have delayed inspectors’ entry into the facility.
“Whistleblower complaints come to the agency in many different ways and from many different sources,” said Dr. Steven Solomon, an FDA veterinarian who oversaw the review. “One of the actions we’ve already taken is to ensure that regardless of whether they come into the agency, they’re triaged and escalated to the right levels of leadership.”
According to the report, FDA inspectors collected bacterial samples from the facility for testing, but shipping issues by “third-party delivery companies” delayed the results, the report says. The FDA has also faced challenges ramping up its testing capacity for Cronobacter, a rare but potentially deadly bacterium that has been repeatedly linked to outbreaks in baby food.
The FDA also noted that it had to postpone its initial inspection of Abbott’s facility due to COVID-19 cases among company employees. This delay came on top of previous missed inspections because the agency pulled its inspectors off the field during the pandemic.
The report concluded by listing new resources that Congress would need to authorize to improve infant formula inspections and standards, including:
— Increased funding and hiring capability to recruit FDA food department experts;
— Enhanced information technology to share data on FDA inspections, consumer complaints and test results;
— New power to force manufacturers to release samples and records of manufacturing supply chains, manufacturing quality and safety.
According to IRI, a market research firm, U.S. baby food inventories have improved, taking inventory rates to over 80% last week. That’s up from a 69% low in mid-July. The US has imported the equivalent of more than 80 million bottles of formula since May, according to the White House, and the Biden administration is working to help foreign manufacturers stay in the market long-term to diversify supply.
Califf commissioned a separate external review of the FDA’s Food Division that identified “fundamental issues surrounding the structure, function, funding, and governance” of the program. This review is led by former FDA Commissioner Dr. Jane Henney, who headed the agency in the final years of the Clinton administration.
Follow Matthew Perrone on Twitter: @AP_FDAwriter.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
Copyright 2022 The Associated Press. All rights reserved.