The head of the Food and Drug Administration has admitted the US regulator’s response to the country’s infant-formula crisis has been below par.
“I’d say because of the outcome, I’d give it at best a four or five” out of ten, FDA Commissioner Robert Califf said during a US House oversight committee grilling, when asked to rate the regulator’s “performance to the situation” in the saga dating back to at least October.
Dr. Califf was sworn in as Commissioner on 17 February, the same month Abbott issued a voluntary recall of infant formula linked to its Michigan factory in Sturgis amid fears of the presence of Cronobacter sakazakii or Salmonella.
Operations at the plant were duly suspended and an investigation launched in collaboration with the FDA and the Centers for Disease Control and Prevention (CDC), leaving Nestlé-owned Gerber and Reckitt Benckiser to ramp up production in a country with few baby-food manufacturers.
Panic buying then ensued as mothers scrambled to feed their babies, especially those requiring specialist formula, exacerbating the shortage and prompting President Biden to evoke an emergency Defence Production Act this month to allow in imports from overseas.
Califf, who also served as FDA commissioner from February 2016 to January 2017, pledged reform as he conceded the food component within the regulator’s remit has been left behind. The food side needs a “shot in the arm,” he told the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce.
“The result is, I say, is not what we would have wanted, so I cannot give it a high rating,” Califf said when asked to rate the FDA’s urgency in responding to the shortage of formula on retail shelves.
The response “was too slow”, he admitted, adding: “There were decisions that were suboptimal along the way. I got many calls from people concerned about the food side of the FDA because of the lack of resources and concerns about the organisational structure. My basic plan has been to get through this crisis and then we will be looking at the overall food programme from the perspective of reforming it, but not waiting to deal with the specifics of this case.”
Multiple members of the panel were “furious” with the shortages playing out in the US and expressed concerns over the conduct of Abbott following revelations from a former employee over practises at the Sturgis plant.
Centre stage was the FDA’s four-month delay in taking action to address the concern. Media firm Politico reported in April that health officials in Minnesota first alerted the FDA and CDC in September to possible Cronobacter sakazakii contamination after an infant was hospitalised after consuming formula made at Sturgis. Four infants have been affected, and two have died.
Abbott has previously said “there is no conclusive evidence to link Abbott’s formulas to these infant illnesses” following the FDA and CDC investigation: “Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella. All retained product tested by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter sakazakii and/or Salmonella. No Salmonella was found at the Sturgis facility.”
However, the FDA did not interview the whistleblower until December and it was not until 31 January that the authority inspected the plant. On 17 February, the regulator informed people against consumption. The employee made allegations of sub-standard cleaning practises and the falsifying of records, among other claims.
Christopher Calamari, an Abbott senior vice president and president of US nutrition, underwent a similar grilling over practices at Sturgis after a similar incident in 2019, when the presence of Cronobacter sakazakii was detected before cans were shipped to consumers.
Calamari was asked by Committee member Morgan Griffith to outline the protocols Abbott is putting in place: “Some of those key areas that we are improving are including the installation of non-porous flooring … improvements across different processes and traffic patterns within the plant, additional training of employees to address some of the observations that were identified,” he responded.
“Our improvements ranged from the physical to the process, and all throughout the facility.”
But Griffith was not convinced, alluding to claims roof workers at the plant waded through the food production area with muddy boots and of not inspecting formula cans at the proper time.
“I think you’ve got more than a porous floor problem or a roof problem at Sturgis, when you look at the FDA reports over the years, and you see similar problems occurring,” Griffith pressed, adding: “What steps are you taking to change that culture and have any heads rolled?”
Calamari said: “On the culture problem. I don’t think it’s a problem. We were there last week and I saw generations of employees who work in Sturgis with pride, who feed their own families, and they are committed to making steps to improve. And we’re making those steps to address in the plant, physically, processes.”
He also outlined the steps Abbott is taking to support interim formula supply amid suggestions from Committee members the Sturgis plant will reopen on 4 June.
Abbott has airlifted “millions of cans” of formula into the US from its facility in Ireland, numbering almost 50 flights a week across 12 major airports, converted its liquid manufacturing lines to make Similac liquid, and is running plants in Ohio, Arizona and Virginia round the clock.
“By the end of June, we expect we will be supplying more formula to Americans than we were in January before the recall,” Calamari said.
“We are also working closely with our regulators to restart production at Sturgis, which will further increase our manufacturing capacity by 40%. As I said earlier, safety comes first. At Sturgis, we regularly take samples across our operations to ensure the facility and the product we produce is safe and we regularly test our formula before, during and after the production process, exceeding regulatory requirements.
“We will also continue to look for new ways to improve because operating a clean and safe plant is a job that requires constant vigilance. We plan to start production at Sturgis the first week of June.”
Nevertheless, he reiterated it may take six to eight weeks to get products on shelves from the Sturgis plant.
Last week, Abbott entered a so-called consent decree with the FDA to take “corrective actions” to get the Sturgis plant operational again.
Calamari informed the oversight committee: “We’ve made a variety of updates to the plant and now we’re in the stages. It’s a 700,000 square-foot facility. So now we’re cleaning, testing, validating to make sure every process step is in place, every quality check is in place to make sure when we get up and running, we could do so in a sustained fashion.”
Meanwhile, the FDA’s Califf was asked if the regulator will push for changes in staff and management at Abbott.
“We will be there until we’re comfortable, not just that the plant is physically okay, but that the systems and people are the right people to be in place,” he said.