The Baby Blame Game | the new yorker

For C-loversSPAN and institutional accountability, a small casualty of the pandemic era has been the adversarial drama of a proper congressional committee hearing. There is catharsis, even Schadenfreude, in the hours-long interrogations of evil government officials or corporate executives embroiled in a scandal, but the glitchy, covid-secure versions of such events turn the oak-paneled reckonings under vaulted ceilings into just another Zoom meeting. This disconnect was evident Wednesday, when the House Committee on Energy and Commerce convened a audience about the communication breakdowns, lack of foresight and gross negligence that have contributed to the continued shortage of infant formula in the United States. Frantic parents and starving babies afflicted by the crisis — which has been going on for months and will continue for weeks, at least — are the few voters who can inspire bipartisan outrage in Congress. But it’s hard to project righteous outrage from your living room or, in the case of one committee member, what looked like the front seat of a car.

The chronology of the disaster is beyond comprehension. Abbott Nutrition, a subdivision of the multinational health care conglomerate Abbott Laboratories, controlled at least 40% of the infant formula market in the United States, and manufactures about 40% of that formula at a single facility in Sturgis, Michigan. On September 20, 2021, the Food and Drug Administration was notified that a baby had contracted a bacterial infection, caused by Cronobacter sakazakii, after consuming a formula made at the Sturgis plant. Coincidentally, on the same day, as Politico’s Helena Bottemiller Evich later reported, FDA inspectors were performing a routine check of the facility. They did not register any major safety issues, although they recommended “voluntary action” to address cleanliness and sanitation. Then, in October, a former Sturgis plant worker sent a shocking message whistleblower report to senior FDA officials. He alleged that Abbott falsified records, shipped untested and potentially contaminated preparations, allowed lax cleaning practices and withheld information from FDA inspectors. (Abbott, who is investigating the report, said the whistleblower was a former employee who, after being “terminated for serious violations of Abbott’s food safety policies,” made “evolving allegations, news and growing to multiple authorities”) The whistleblower report was in the possession of the FDA for months before reaching senior officials. A new FDA inspection of the Sturgis plant did not begin until January 31, 2022.

Finally, on February 17, Abbott closed the Sturgis plant and issued a voluntary notice recall of certain batches of three of its infant formula brands, after four babies who consumed Abbott products contracted bacterial infections in Minnesota, Ohio and Texas. Two of the babies later died. Abbott denied that its products were to blame; strangely, part of the company defense was that each baby consumed a different formula from the Sturgis plant and they got sick at different times. The FDA’s January inspection found five strains of Cronobacter the.

This single facility, which remains closed, accounted for approximately 20% of the entire national infant formula supply, including Similac (which, in infant formula wars, is the Coke in Enfamil’s Pepsi) and EleCare, a specialized formula for children with food allergies and digestive disorders. The immediate effects of the shutdown and its near-immediate repercussions on the rest of the formulas market were evident. Pandemic-era supply chain issues had already left many store shelves empty of formula in early 2022, as the the wall street journal reported one month before the closure of the Sturgis plant. Abbott is the primary formula supplier for the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), whose recipients make up more than half of the national market for formulas; according Truth“Abbott Nutrition is the sole supplier of infant formula to U.S. government assistance programs in 34 states, seven Indian tribal organizations, four territories, and Washington, D.C.” In early spring, the accounts has proliferated from parents driving for hours to find formula, rationing supplies or even replacing water or homemade formula. Pediatricians have reported seeing more patients with weight loss. Advertisement on eBay reportedly offered formula crates for hundreds of dollars each. Robert Ford, chairman and CEO of Abbott, later recognized that some children who depend on EleCare have been hospitalized.

Somehow, the widespread stories of desperate parents unable to feed their children did not inspire immediate federal action. On May 18, three months after the Sturgis plant closed, President Biden invoked the Defense Production Act to require suppliers of formula ingredients to prioritize deliveries to formula makers and allow commercial aircraft contracted by the Pentagon to transport formulas from overseas. On the same day, the House adopted additional supply invoice giving the FDA twenty-eight million dollars in emergency funds to deal with the shortage. (One hundred ninety-two Republicans voted against Bill, including Morgan Griffith of Virginia, a member of the Energy and Commerce Committee who asked during Wednesday’s hearing why the FDA and Abbott were not “working at breakneck speed” to address to the crisis.) Asked at a press conference if the administration could have taken action sooner, Biden replied, “If we had been better mind readers, I suppose we could have, but we acted as quickly as the problem dawned on us.” (Abbott has a decree of consent with the FDA for a reopening of the Sturgis plant, tentatively scheduled for June 4; from then on, it would take another four to eight weeks for the formula produced there to hit store shelves.)

As several committee members pointed out on Wednesday, the Sturgis collapse is likely a microcosm of lingering systemic issues at Abbott, which in 2010 reminded millions of units of Similac produced at the Sturgis plant after beetles and their larvae were found in the product. Surprisingly, Christopher Calamari, senior vice president at Abbott, claimed during the hearing that he had no knowledge of the whistleblower’s October report until late April, when Representative Rosa DeLauro, a Democrat from Connecticut, share with the audience. New York State Democratic Congresswoman Kathleen Rice elicited the most memorable response when she repeatedly pressed Calamari to explain why the company had to rely on a whistleblower to reveal security deficiencies at a Michigan facility. “Rep,” Calamari replied, “this, uh, the nature of this, uh, process is, uh, this, uh, when it was made public, it was, uh, shared with the FDA, and I don’t I wasn’t, uh, directly aware of the investigation until then.

The report is horrible to read. The factory, the whistleblower wrote, periodically failed to seal formula cans properly and, to work around the problem, performed safety tests on empty cans instead. He alleged that he was expected to rig quality assessment procedures and that some equipment at the Sturgis plant had been in poor condition for years, which “resulted in product circulating in the pipes picked up bacteria that were trapped in the defective areas of the pipe.” The whistleblower also detailed an uneven record-keeping system, maintained largely on paper; a member of management allegedly suggested to him “that electronic records would make the Sturgis site more accountable to others at the division level. and business.” The report also highlighted shortcomings in the FDA inspection process. In 2019, the Sturgis plant produced a batch of preparations that tested positive for microorganisms; in response, the report claims that Abbott only destroyed the portion of the batch it deemed to be contaminated and released the rest to market. That same year, the factory passed an FDA safety audit. A member of management, claims the whistleblower, “said she was surprised the FDA could not find out what happened with the micro-lots.”

Abbott and the FDA are curious counterparts in this debacle: one incredibly profitable multinational company; the other a perpetually beleaguered, understaffed agency that nevertheless has at least the nominal weight of the federal government behind it. According to a Securities and Exchange Commission deposit, in October 2019, Abbott’s board authorized share buybacks of up to $3 billion; in December 2021, Abbott approved another takeover of up to five billion. One wonders what that money could have done for the pockmarked pipes at Sturgis. Meanwhile, the FDA, like Bottemiller Evich recently reported, has “repeatedly failed to take timely action on a wide range of safety and health issues. . . including dangerous pathogens found in water used to grow produce and heavy metal contamination in baby food,” as well as “many other chemicals of concern, including PFAS, so-called eternal chemicals , which can be found in the food supply and are used in food packaging.” Last year, a House subcommittee released an alarming report reporthighly critical of the FDA, with a direct headline: “Baby Foods Are Contaminated With Dangerous Levels of Arsenic, Lead, Cadmium and Mercury”.

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