WASHINGTON — FDA Commissioner Robert Califf, MD, expressed disgust and disappointment over the conditions at the Abbott baby formula manufacturing plant in Sturgis, Michigan, while an Abbott official apologized and vowed to ensure that the problem would not return.
“There is no dispute that the facility was unacceptably insanitary” when FDA inspectors went to see it on January 31, Califf said Wednesday during a hearing held by the House Energy & Commerce Subcommittee on Oversight and Investigations. “Frankly, the inspection results were shocking: standing water and cracks in the key equipment that present the potential for bacterial contamination to persist, particularly in the presence of moisture. Leaks on the roof, a previous citation for inadequate hand washing, current poor foot sanitation, bacteria growing from multiple sites, and many signs of a disappointing lack of attention to the culture of safety in this product that is so essential to the lives of our most precious people.”
Trouble Surfaced in February
The origins of the shortage go back to February 17, when Abbott Nutrition announced a voluntary formula recall following concerns about bacterial contamination at the Sturgis facility; four infants fell ill and two died after drinking the formula. At the hearing, Califf said that although an investigation by the FDA and the CDC “could not conclude that the egregiously unsanitary conditions in the Abbott facility caused the illnesses … we cannot rule it out either, as the confluence of events is highly unusual.”
The plant has since gone offline, and on May 16, the FDA announced it had reached an agreement with Abbott on a joint consent decree aimed at solving the problems at the Sturgis facility, although the company said at the time that it would take 2 weeks for the facility to resume production. On May 19, the Biden administration said it was invoking the Defense Production Act to speed up formula manufacturing at other plants, and also launched Operation Fly Formula to send available formula from overseas to the areas that need it most.
Congress also got into the act; on May 18, the House passed two bills — mostly along party lines — to help ease the formula shortage, The Hill reported. The main bill would give the FDA $28 million in emergency funding to improve formula plant inspections and better prepare the industry for supply chain disruptions; it is unclear whether the Senate will also pass the bills. Both chambers did pass — and President Biden signed — a bill allowing the Department of Agriculture to address supply chain disruptions in order to help participants in the Women, Infants, and Children (WIC) program obtain formula.
More Action Needed
But Rep. Frank Pallone (D-N.J.), chairman of the full Energy & Commerce Committee, said Wednesday that what Congress has done so far isn’t enough. “Additional legislation will be necessary to improve transparency and reporting requirements and to empower FDA to set limits on contamination,” Pallone said. “Industry must also do its part to ensure robust internal controls are in place and are being followed to prevent contaminated products from ever reaching a single child … We must all work together to guarantee the safety and supply of baby formula to ensure the health of our nation’s children.”
The FDA came in for its share of criticism during the hearing. “There are several reasons for the shortage, including failure by the FDA and the administration to act early enough to address supply shortages, and the Abbott shutdown made it worse,” said Rep. Cathy McMorris Rodgers (R-Wash.), ranking member of the full Energy & Commerce Committee. “The Biden administration says it did not anticipate the formula shortage, but it should have. As a part of its pandemic response, FDA had a data and analytics tool to monitor the supply chain of various products, including infant formula.”
“The FDA’s Food Safety Center was in contact with the infant formula industry to monitor ingredients and other components for production and to maintain a healthy and safe supply,” she said. The agency “just had to read their own data and listen to parents. With Abbott being a major supplier and given the information at its disposal, the FDA should have known the plant closure would make the shortage even worse.” With regard to the Abbott shutdown, McMorris Rodgers noted that in October 2021, “the FDA received a 34-page complaint about the Sturgis plant from an Abbott ex-employee who alleged data falsification and release of untested product … FDA reportedly did not interview the whistleblower until months later and did not [inspect] the plant until January 2022.”
Califf, who took office in mid-February, admitted that the agency’s performance in this area had been less than ideal. “FDA’s timeliness of interviewing the whistleblower and getting into the facility for a for-cause inspection were too slow, and some decisions in retrospect could have been more optimal,” he said, adding, “I did not return to FDA to preside over business as usual.”
‘We Are Deeply, Deeply Sorry’
Christopher Calamari, president of the U.S. and Canada Nutrition division at Abbott, apologized to the committee. “The current infant formula shortage is heartbreaking. On behalf of everyone at Abbott, I want to express our extraordinary disappointment about the shortage. We are deeply, deeply sorry,” he said. “And we are committed to ensuring that this never happens again.”
He outlined five steps the company was taking to ease the shortage: re-organizing its global network of manufacturers to create additional capacity in the U.S. market, airlifting millions of cans of powdered infant formula into the U.S. from its facility in Cootehill, Ireland; converting other Abbott liquid manufacturing lines to make Similac ready-to-feed liquid; running other Abbott manufacturing facilities in Ohio, Arizona, and Virginia “24/7” to help replenish supply; working with the Agriculture Department and WIC to ensure WIC participants will continue to obtain formula free of charge; and for babies with special needs, releasing metabolic formulas previously on hold and working with other manufacturers to address demand.
Rep. Kathleen Rice (D-N.Y.) wanted to know why the whistleblower went to the federal government and not to the company with their complaint. Calamari said that the company “does have a process in place where employees can raise their voice and speak up” — a process that is independently administered and respects employee confidentiality. “We encourage employees to speak up, and safety and compliance is a top priority,” he said. Rice asked him why the employee didn’t go to the company first; Calamari said it was “their choice” to go outside of the company.
“Why did your system fail here?” Rice said. “And what are you going to do to make sure that it doesn’t happen again?” Calamari said Abbott was going to “encourage employees to speak up; we’re going to reinforce that we are a culture where we support employees to raise concerns if they see them. And I think that’s one of our ongoing commitments as an organization.”
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