— Experts at House Oversight subcommittee hearing say U.S. is vulnerable to another crisis
Sophie Putka, Enterprise & Investigative Writer, MedPage Today
March 28, 2023
Lawmakers drilled into the FDA’s handling of the infant formula crisis and proposed solutions at a House Committee on Oversight and Accountability subcommittee hearing Tuesday, underscoring the still-precarious position that the U.S. finds itself in.
Questions at the hearing highlighted the missteps by the FDA that led to the crisis, but also pointed to an industry chokehold on the formula market that formed its backdrop — and could set the stage for another.
Proposed solutions were a more unified FDA approach to food safety, more regulation and authority for the FDA to hold formula companies accountable, and diversification of the infant formula market.
“The nation remains one outbreak, one tornado, or cyberattack away from finding itself in a similar place to that of February 17, 2022,” said Frank Yiannas, MPH, the former deputy commissioner of food policy and response for the FDA, who was also the head of food safety at Walmart for 10 years.
The reckoning comes a month after a second infant formula recall from Reckitt, which — though smaller than 2022’s Abbott recall — revealed lingering weaknesses in the FDA’s performance. The agency was again slow to respond, with a 5-month gap between Reckitt’s positive test and a recall, according to Politico.
Among other problems rehashed in the hearing, the FDA allowed 2 years to lapse before a routine inspection of Abbott’s plant, during which they found nothing serious enough to warrant taking action. Furthermore, despite a whistleblower complaint to the FDA in October 2021, and four reports of infant illnesses from Cronobacter bacteria, it wasn’t until late January 2022 — 4 months later — that the FDA reinspected the plant. They found multiple strains of the bacteria and other problems that Yiannas called “egregious,” including water leaks, standing water, and a spray drier with cracks from the 1960s.
This report didn’t reach Yiannas’ desk until late February, and a week later, Abbott issued a voluntary recall. Because they were responsible for about 40% of the infant formula market, the recall had ripple effects and led to a run on infant formula, with parents driving from store to store to feed their children.
“Clearly, I really wish — and I should have — been notified sooner, so I could have initiated containment steps earlier,” said Yiannas. “There’s no question that FDA’s siloed and decentralized foods program structure and culture contribute to exasperate these delays.”
In response to questioning from Rep. Alexandria Ocasio-Cortez (D-N.Y.), Yiannas said that current FDA testing standards remain its “Achilles’ heel.” Because current rules require only 300 mg of formula to be tested across 30 samples, and manufacturing runs can be tens of thousands of pounds of formula, “the probability of finding contamination is virtually zero,” he said. “It’s been a free pass for them [formula companies] to say it’s tested negative.”
When Rep. Glenn Grothman (R-Wis.) asked whether the regulation of food, as opposed to drugs and medical devices, is an “afterthought” at the FDA, Yiannas replied, “Food has taken a backseat to drugs.”
Democratic representatives pointed toward virtual industry monopolies by formula makers and their role in setting the market up for failure. The Women, Infants, and Children (WIC) Program, which is responsible for around 50% of formula sold nationally, is set up with what’s known as sole-source contracts, which ensure that WIC can only use one company’s products in each state — and, in turn, skews the rest of the supply in the state toward that one maker, according to Yiannas.
Solutions offered up during the hearing centered around both the FDA’s regulatory muscle and diversifying the infant formula market.
The hearing’s second witness, Peter Lurie, MD, MPH, president and executive director of the Center for Science in the Public Interest in Washington, D.C. and the former associate commissioner for public health strategy and analysis for the FDA, said the agency “should have the authority to require manufacturers to notify the agency of all positive test results,” require companies to test facilities more frequently, and require them to submit supply chain data.
Though not an FDA issue, he and Yiannas also stressed the importance of making Cronobacter a nationally notifiable illness.
While Yiannas called a recent proposal to restructure parts of the FDA’s Human Foods Program by FDA Commissioner Robert Califf, MD, “well intentioned,” he said it gave the role of deputy commissioner even less oversight than it has had in the past. Rep. Lisa McClain (R-Mich.), chair of the subcommittee, called it “weak.”
While the Food and Drug Omnibus Reform Act of 2022 set certain requirements for formula manufacturers to manage supply chain risks and established a new office around “critical foods,” Yiannas noted, “progress is being made, but it’s not being made fast enough.”
Even if “we had an ideal, perfect, pristine FDA working in the mix,” said Rep. Jimmy Gomez (D-Calif.), would it have made up for a market where four companies control 90% of the nation’s formula? According to Yiannas, the answer is still no.
However, as witnesses pointed out, diversifying the market would be outside the scope of the FDA’s role, apart from approving new products more quickly. Part of the solution would involve the U.S. Department of Agriculture, which runs the WIC program, and relies on the sole-source state contracts that made recovering from the shortage so difficult. This, said Yiannas, creates an “artificial market incentive.”
According to Rep. Katie Porter (D-Calif.), “we have to stop turning a blind eye to consolidation in our food markets.”
Porter closed out the hearing by calling on all parties responsible for the infant formula crisis to hold themselves accountable, with “no pass today for Washington, no pass today for manufacturers, no pass for anyone.”
A follow-up hearing on April 19 will feature current FDA officials.
Sophie Putka is an enterprise and investigative writer for MedPage Today. Her work has appeared in the Wall Street Journal, Discover, Business Insider, Inverse, Cannabis Wire, and more. She joined MedPage Today in August of 2021. Follow
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