A subcommittee of the U.S. House Energy and Commerce Committee is set to begin a hearing on infant formula shortages, which are related to recalls of products linked to an outbreak of cronobacter infections.
The Oversight and Investigations Subcommittee is scheduled to open the hearing on May 25, according to an announcement from Committee Chairman Rep. Frank Pallone Jr., D-NJ.
“The nationwide infant formula shortages are increasingly alarming and demand Congress’ immediate attention,” Pallone said.
“Ensuring the safety and well-being of our nation’s children, including safe and nutritious formula, is one of our most important collective responsibilities. I commend the Biden Administration and the Food and Drug Administration’s recent actions to increase supply of infant formula and stand ready to work together until this shortage is resolved.
“The focus of this hearing will be on better understanding the causes of the shortage, what has been done to increase production and supply thus far, and what more still needs to be done to ensure access to safe formula across the nation.”
Although supply chain issues related to the COVID pandemic have been cited by the FDA and Abbott Nutrition — an infant formula manufacturer at the heart of the story — the main cause of the shortages is the closure of one of Abbott’s plants and its recall of numerous infant formula products. The recall and closure of Abbott’s plant in Sturgis, MI, are related to an outbreak of cronobacter infections that has seen four babies hospitalized with two dying.
It is not yet known how much if any of the subcommittee’s hearing on the infant formula shortage will focus on the FDA’s investigation into the outbreak and conditions at Abbott’s manufacturing facility.
The subcommittee has not yet released a list of witnesses expected to testify.
“Additional details will be announced the week before the hearing,” according to the committee announcement.
Since shortly after the Abbott recall on Feb. 17, parents across the country have been complaining that they are having to spend hours looking for infant formula and driving long distances to buy it. Mainstream media outlets continue to post stories about the parents’ complaints on a daily basis. The recall includes products sold under the brands Similac, Alimentum and EleCare.
Earlier this week the Food and Drug Administration released details of what it is doing — “working around the clock” — to alleviate the shortage. Agency officials say there actually is not a shortage because sales of infant formula in April exceeded those in March.
Abbott and the FDA have come to an agreement for the case-by-case release of some speciality formulas to help ease the situation for parents of infants who have certain health problems.
The FDA has been investigating Abbott and its manufacturing plant since January. The agency began receiving reports of illnesses and the deaths of two babies in September 2021, but did not begin its investigation until early this year. Samples from the Sturgis, MI, plant have shown five different strains of cronobacter, but none are an exact match for patient samples.
The lag time between the first illness report and the beginning of the FDA investigation has been widely criticized by lawmakers.
Earlier this year U.S. Rep. Rosa DeLauro, D-CT, wrote a letter to the Inspector General of the U.S. Department of Health and Human Services demanding answers to questions about the investigation. Also, U.S. Sen. Patty Murray, D-WA, wrote to the FDA seeking information about the investigation.
On April 28, DeLauro entered into the record a whistleblower document that detailed a culture of food safety failures at the Abbott manufacturing plant and renewed her criticism of the FDA’s investigation.
“I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. We need to know exactly who in the company was aware of this failure and the alleged attempts to hide this information from the FDA,” DeLauro said during a meeting on the Fiscal Year 2023 Budget Request for the United States Department of Agriculture.
“I am equally concerned that the FDA reacted far too slowly to this report. The report was submitted to the FDA on Oct. 20, 2021. The FDA did not interview the whistleblower until late December 2021. According to news reports, FDA did not inspect the plant in person until Jan. 31, 2022, and the recall was not issued until Feb. 17, 2022.”
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