Food and Drug Administration Commissioner Robert Califf took criticism from both Democrats and Republicans on a House subcommittee over the baby formula shortage on his watch that has left many parents desperate.
The FDA has come under fire for its slow response to the crisis. Members of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee criticized Califf on Thursday for the agency’s failure to respond to early warning signs of health and safety violations at Abbott’s manufacturing plant in Sturgis, Michigan.
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“We need to get to the bottom of the disgraceful lack of oversight and the terrible safety issues from an Abbott Nutrition manufacturing plant that led to at least two babies dying and several others being hospitalized,” said House Committee on Appropriations Chairwoman Rosa DeLauro (D-CT). “We need also to get to the bottom of FDA’s slow response."
The representatives also charged the FDA with delaying its actions on reports last fall of infants becoming seriously ill after consuming some of Abbott’s formula produced at that site.
“The shortage was caused in large part by the lack of action by the FDA and by corporate greed and consolidation, in this case, Abbott putting profits and production over people,” DeLauro said.
Califf came under fire for the agency’s slow response to a whistleblower report authored by a former Abbott employee in October, claiming that the company falsified records, maintained lax cleaning standards, concealed problems the facility had detecting bacteria in formula from the FDA, and released untested formula into the market. But the agency did not interview the whistleblower for another two months and did not launch an inspection of the facility until Jan. 31.
Republicans on the committee, meanwhile, said the Biden administration has been moving too slowly on addressing a wide range of topics, including inflation, problems in the manufacturing supply chain, and the continued problem that COVID-19 poses — and the baby formula shortage is no different.
“This has become a dangerous and unacceptable situation,” said Rep. David Valadao (R-CA). “This administration appears interested in alleviating the issue, but it's taken too long to get to this point. … Did the FDA treat this just like every other or any other recall that they've had to deal with, or did they understand the gravity of the situation from the beginning?”
Califf insisted that the agency began addressing problems with the Abbott plant last fall, when the first case of bacterial infection in an infant who drank the formula was confirmed in Minnesota. The Centers for Disease Control and Prevention recently concluded its investigation into the plant and violations committed there. Abbott announced that the disease-causing bacteria, Cronobacter sakazakii, was only found in nonproduct contact areas of the facility and had not been linked to any known infant illness. But Califf did not say the company was in the clear yet.
“Using genotyping, we could not connect the cases directly to the Abbott plant, that is correct, but the investigation is not over because cronobacter is a very difficult organism to culture,” Califf said. “And we do have five cultures that are positive for different types of cronobacter from the Abbott plant. They just don't match up, and so the plant definitely needed to be dealt with.”
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The Sturgis plant is set to reopen within the next couple of weeks after striking a legally binding deal with the FDA that, if approved by a federal court in Michigan, would allow Abbott to resume manufacturing powdered infant formula at the Sturgis facility. The Abbott plant’s closure was just one catalyst of the infant formula shortage. In addition, the COVID-19 pandemic strained supplies of ingredients needed to make the formula and led to worker absenteeism due to sickness or exposure to the coronavirus.