The Subcommittee on Health Care and Financial Services recently held a hearing to hear testimony to examine the FDA's response to the 2022 bacterial outbreak at the Abbott Nutrition facility that led to the deaths of two infants and caused a shortage of baby formula across the nation.
According to the Center for American Progress, at the beginning of 2022, between 2 and 8% of baby formula products were out of stock in stores across the nation. In May 2022, the share of formula products out of stock had risen to 43%. Some states saw even larger shortages, with Iowa, Missouri, Texas and North and South Dakota seeing more than half of formula products out of stock, according to the Center for American Progress. Baby formula products that remained in stock had become significantly more expensive – the cost of some of the most popular baby formulas increased by 18% between June 2021 and June 2022.
This February, one year after the recall of Abbott's products, some families were still struggling to find enough formula for their children, 19th News reported. Some stores, like Target and CVS, have limits in place on how much formula can be purchased at one time.
The Subcommittee on Health Care and Financial Services is led by Chair Lisa McClain (R-MI) and Ranking Member Katie Porter (D-CA). Frank Yiannas, MPH, the former deputy commissioner of food policy and response at the U.S. Food and Drug Administration (FDA) and Dr. Peter Lurie, president and executive director of the Center for Science in the Public Interest were present at the hearing as witnesses to provide testimony to a panel of lawmakers and leaders.
According to House documents, the hearing was held to review the FDA's response to the February 2022 discovery of the Cronobacter sakazakii bacteria outbreak at the Abbott Nutrition facility in Sturgis, Michigan and the subsequent nationwide shortage of infant formula. The Abbott facility was responsible for the production of more than 40% of the U.S. supply of powdered infant formula. After two babies died from Cronobacter infections, Abbott recalled all formula that had been produced in the Sturgis facility, leading to a nationwide infant formula shortage. The hearing was held to determine how the crisis happened, how it could have been handled better and to determine if the FDA can prevent a similar event from happening in the future.
In her opening statement, McClain stated that in the summer of 2021, the FDA was already aware of a significant supply chain disruption resulting in potential shortages of several types of baby formula and that the Abbott facility had not been inspected in two years as of September 2021. In October of that year, a whistleblower at Abbott submitted a 34-page report relaying their concerns about the Abbott facility, which noted the company's lax cleaning practices, falsified records and relevant information withheld from FDA inspectors. Despite the report and other reports of babies becoming sick, the FDA didn't begin investigations of the plant until Jan. 31, 2022. The plant would voluntarily shut down operations and issue a recall of its products a few weeks later.
"The infant formula crisis underscores a major problem with the FDA. The FDA is responsible for 78% of the U.S. food supply, but the FDA is not prioritizing food safety," McClain said. "The health of vulnerable infants that rely on formula as a single food source was not a priority."
Porter questioned if Congress had done enough over the past few years to give the FDA the power and resources it needs to be proactive in addressing disruptions in critical food markets. She said that although the FDA bore responsibility, the problem was primarily a big business problem. According to Porter, as manufacturers of food products, formula manufacturers' primary responsibility are to produce safe products. She also stated that the infant formula market doesn't have many manufacturers and that the market should be diversified to increase resiliency of the supply chain. Abbott is currently one of three manufacturers that collectively control 90% of the infant formula market.
In his testimony, Yiannas stated that despite the disaster, understanding the steps leading up to the event and contributing factors that allowed it to occur in the first place remain elusive. By his estimation, safeguards for the infant formula market needed to prevent future illnesses haven't advanced adequately enough since the 2022 outbreak and the infant formula market continues to lack resiliency.
"In other words, the nation remains one outbreak, one tornado, flood or cyber attack away from finding itself in a similar place to that of Feb. 17, 2022."
Lurie pointed out the many missteps of the Abbott facility that led to the outbreak in his testimony. According to Lurie, the plant had detected formula that had been contaminated with Cronobacter years before the outbreak and destroyed it, but failed to notify the FDA. He stated that much of the FDA's response to the disaster was appropriate, but that the agency took too long to respond to reports and schedule appropriate investigations, ultimately delaying the necessary recall.
Lurie believes that better prevention of future crises will require increased authority, improved funding and a more effective organizational structure. He said that the FDA should have the authority to require all manufacturers to notify the agency of all positive results for contamination, require more frequent environmental testing at manufacturing facilities and require manufacturers to submit supply chain data. He added that food programs require more funding to increase review capacity for infant formula, for pre-market notifications, to increase surveillance of adverse events and improve laboratory methods to detect Cronobacter and increase turnaround speed of inspection findings. He believes that the development of a food program with a structure that is transparent, effective and accountable will improve FDA response and performance.
Yiannas' strongest recommendation was that Cronobacter sakazakii be made a nationally notifiable disease and reportable nationwide. Formula manufacturers are currently not required by law to report contaminations to the FDA, a fact that shocked the subcommittee and panelists, and Cronobacter sakazakii is only a reportable disease in two states.
Following a discussion with panelists, McClain thanked the witnesses for their testimony and commended them for their work to provide solutions to prevent and respond to future outbreaks.
