Lawmakers on Capitol Hill hammered officials at the Food and Drug Administration and an executive of Abbott Nutrition on Wednesday over wide-ranging failures that they said contributed to the nationwide baby formula shortage, demanding aggressive measures to increase trust in the food supply and prevent another formula crisis.
“I’m pretty furious about the FDA’s lack of food safety leadership, communication and action,” said Rep. Janice D. Schakowsky (D-Ill). “Food safety for decades has been a real problem.”
But committee members also sought answers from Christopher Calamari, president of Nutrition North America for Abbott, about unsanitary conditions at a plant in Sturgis, Mich. FDA inspections turned up evidence of workers handling materials without washing hands, and pitting in dryers that could harbor bacteria. The shortage largely stems from a February recall and shutdown of the factory, which produced most of the country’s supply of powdered Similac and some specialty formulas.
Calamari apologized for the formula shortage but defended his company’s practices. He said the company has always moved quickly to address any problems, or “observations,” flagged by the FDA.
“We have a decade of reviews and inspections at the Sturgis facility, and in 2019 when there was an observation, we quickly addressed it,” he said. “And in 2021, we took action to address those observations. We value our relationship with our regulators; we have a safety-first [position] and have prioritized compliance.”
The issues have come to the surface in the wake of a formula crisis that has left many parents scrambling to feed their infants and medically fragile children.
In October, a whistleblower submitted a scathing report alleging unsanitary conditions at the Sturgis plant, but senior staff at the FDA did not respond for four months.
At the hearing, Califf acknowledged that the process took too long and that “some decisions in retrospect were not optimal.” He said senior officials were not aware of the whistleblower report until Feb. 9 or 10. In his written testimony, Califf said the delay in inspecting the Abbott plant was the result of a coronavirus outbreak at the facility and that the lag in senior agency officials receiving the whistleblower’s report was a “failure in FDA’s mailroom.”
Frank Yiannas, the agency’s top food safety officer, confirmed at the hearing that he didn’t receive the report until “around Feb. 10 or thereabouts.”
“I’m not sure why the report wasn’t shared with me. There’s going to be a review and we’re going to try to get to the bottom of it,” he said.
The FDA eventually mounted an inspection of the Sturgis plant on Jan. 31 in response to reports that four infants were sickened or died after consuming formula produced at the plant — but not for three months after the reports surfaced. The inspection turned up allegedly unsanitary conditions. But nearly four months later, the facility remains shuttered, leaving supplies severely constricted.
Califf said the agency had “no choice” but to shut down the plant, saying the problems his agency found there were “beyond the pale.”
Califf said he had tapped Steven Solomon, director of the FDA’s Center for Veterinary Medicine, to oversee the investigation of what went wrong in the handling of the Abbott facility — not, as he suggested in a hearing last week, Janet Woodcock, the FDA’s principal deputy commissioner.
Rep. Billy Long (R-Mo.) asked the commissioner to rate the agency’s response on a scale of 1 to 10.
“Because of the outcome, I’d give it at best a 4 or 5,” Califf said. “I knew before coming in that food needs to be brought back at the FDA; it’s a major issue.”
Rep. Diana DeGette (D-Colo.) said that while “Abbott is not blameless, one company is not responsible for the situation and there is much more to learn about the agency’s actions.”
Rep. H. Morgan Griffith (R-Va.) spread the blame more broadly, saying that President Biden had flippantly told reporters that the administration might have done better if it had been “better mind readers.”
“Where was the Biden administration plan to deal with what should have been a foreseeable event? It wasn’t until mid-May that the administration took this seriously and began to act,” Griffith said.
The Biden administration launched Operation Fly Formula, using Defense Department planes to transport up to 1.5 million eight-ounce bottles of three hypoallergenic formulas from Zurich to Plainfield, Ind. An airlift delivering 60 tons of formula from Ramstein Air Base in Germany arrived Wednesday at Dulles International Airport.
Abbott announced Tuesday that it had reached an agreement with the FDA to release limited quantities of EleCare hypoallergenic specialty formulas to relieve the shortage, offering the product free to children in need. It also said it will restart production at the Sturgis facility on June 4 and will prioritize EleCare, with the product released to consumers around June 20.
60 tons of formula just arrived on U.S. soil. More is scheduled to arrive in the coming days.@FLOTUS & @Surgeon_General were there to greet the plane that delivered the formula and assure Americans that the @WhiteHouse & @HHSGov will continue working to get formula on shelves. pic.twitter.com/5EExqMDIMP— Secretary Xavier Becerra (@SecBecerra) May 25, 2022
Biden has also directed ingredient manufacturers to prioritize providing supplies to formula companies and has said there would be a crackdown on price gouging or unfair sales practices.
It could be fall before store shelves are fully stocked with Similac and other Abbott products.
Some lawmakers and advocates have expressed frustration that the FDA appeared flat-footed in understanding that Abbott’s Sturgis recall and facility closure — one of the country’s largest manufacturers of formula and the biggest one to serve low-income families — would result in a national shortage that continues to endanger lives.
The Agriculture Department’s supplemental nutrition program for low-income mothers and children purchases half of the infant formula in the United States.
The FDA should have been asking how its actions might impact supply, said Jerry Mande, a senior USDA official during the Obama administration.
“Formula must be safe, absolutely,” he said. “But this is a complex issue, not only for infants, but for others who rely on specialty formula products, where shutting off supply could cause deaths, too. You must carefully balance both and the steps you’re going to take.”