Ahead of formula shortage hearing, House committee sets timeline for supply fights

In a briefing note released ahead of the hearing, Rep. Frank Pallone, D-New Jersey, chairman of the House Energy and Commerce Committee, provided a timeline of the crisis, which began with issues of supply chain and worsened significantly after a nationwide recall and the closure of a manufacturing plant that produced nearly half of the infant formula consumed in the United States.

The memo states that up to 75% of US caregivers partially rely on formula to provide nutrients to their infants up to 6 months of age. The shortage has been most acute for low-income families, those in rural areas and children with medical needs that limit the types of formula they can drink.

Three companies manufacture 95% of infant formula sold in the United States: Abbott, Reckitt and Gerber. Abbott controls about 42 percent of the country’s infant formula supply and holds the contracts to supply about half of low-income families who participate in the Special Supplemental Nutrition Program for Women, Infants and Children, or WIC.

On September 20, 2021, the United States Food and Drug Administration was notified that a child had been diagnosed with an infection caused by Cronobacter bacteria. Cronobacter infections can be serious and even fatal in infants. If the bacteria enters the brain, it can cause abscesses and brain damage, even death. Cronobacter thrives in dry environments and is known to be a contaminant of infant formula.

Between September 20 and February 17, 2022, the FDA would become aware of four Cronobacter infections in infants, including two deaths.

The agency received the report the same day its inspectors arrived at Abbott’s plant in Sturgis, Michigan, for a routine inspection that lasted until September 24.

On October 20, the FDA received a detailed report from a former Abbott employee who accused the company of falsifying records, hiding information from FDA inspectors, distributing untested infant formula, and maintaining lax cleaning practices, as well as an atmosphere of retaliation against workers that raised concerns.

According to a press release from Rep. Rosa DeLauro, D-Connecticut, the FDA did not interview the whistleblower until late December and did not conduct an in-person “cause” inspection of the plant until December 31. January 2022.

Abbott Nutrition recalled certain lots of its Similac, Alimentum and EleCare baby formulas on February 17.

A team of FDA inspectors made a total of 24 visits to Abbott’s manufacturing plant between Jan. 31 and March 18. The agency found that the company had failed to establish processes and maintain surfaces in the facility to prevent formula contamination. The FDA found Cronobacter bacteria in five environmental samples from the factory, but none were found in the product itself.

Genetic testing of Cronobacter strains found at the plant did not match bacteria taken from infected patients.

While the agency’s inspection was ongoing, Abbott closed its facilities to correct issues identified by the FDA, according to the agency’s timeline of events.

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The investigation of Cronobacter disease and contamination at the Sturgis plant has created a perfect storm in an industry hampered by supply chain challenges.

Several of the raw materials used in the production of infant formula (such as milk and vegetable oil) and packaging (such as plastic and tin) have suffered supply chain disruptions in recent months, says the memo. Rising prices of other commodities due to global conflicts, labor shortages, and transportation and logistics issues were contributing factors, the memo said.

Panic buying has contributed to the shortage in recent weeks, leading some stores to limit sales. Others raised prices and scams proliferated on social media.

Other factors have contributed to the shortage, such as the way the WIC awards exclusive contracts to manufacturers, import taxes and restrictions designed to protect U.S. milk producers, and a limited domestic manufacturing base, which which made it difficult to increase production rapidly.

The memo also cites inconsistent consumer demand. During the pandemic, families in need of formula milk stocked up early, driving up demand. Later, demand dropped as families used what they had at home. And fewer babies were born in the first year of the pandemic, which was followed by a slight increase in the birth rate. This volatility has made it difficult for manufacturers to plan production schedules, the memo notes.

The note describes the measures taken by the government to alleviate the shortage. On May 16, Abbott entered into a proposed consent decree with the FDA, creating a pathway to resume production at its Sturgis plant.

Last week, the House passed two bills: one that provides $28 million in emergency spending to increase the supply of U.S. formulas and another that seeks to protect the WIC program from future shortages. President Biden has invoked the Defense Production Act so manufacturers can get the raw materials they need, and Operation Fly Formula has accelerated imports.

Reckitt and Gerber increased production enough to offset Abbott’s loss of production, the memo said.

FDA Commissioner Dr. Robert Califf said the agency plans to investigate how quickly it responded to safety breaches at the Sturgis plant.

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