Former Food and Drug Administration (FDA) officials told a House Oversight subcommittee that factors that led to a shortage of baby formula have been identified but remain unchanged.
Witnesses at a March 28 hearing of the House Subcommittee on Health Care and Financial Services said the agency would need more funding, enforcement authority, and a better organizational structure to avoid repeating the problem.
Committee members expressed little confidence.
“I don’t really trust the FDA,” Rep. Anna Paulina Luna (R-Fla.) said.
Dr. Peter Lurie, former FDA associate commissioner and current president and executive director of the Center for Science in the Public Interest, said problems that left parents searching desperately for formula were present for years. They were waiting for a suitable catalyst for a problem to manifest.
“It took the addition of a pandemic, with its own supply chain problems; Abbot Nutrition’s deficient manufacturing practices; and, later, the war in Ukraine, to produce a full-blown shortage,” Lurie said.
Frank Yiannas, former FDA Deputy Commissioner for Food Policy and Response, agreed. He told the subcommittee that it could all very quickly happen again.
“The nation remains one outbreak, tornado, flood, or cyber-attack away from finding itself in a similar place to that of Feb. 17, 2022,” Yiannas told the subcommittee.
The problem began in the Abbot Nutrition facility in Sturgis, Michigan, where contaminated baby formula was discovered, but committee members weren’t stopping their criticism there.
Democratic ranking member Rep. Katie Porter (D-Calif.) said there’s plenty of blame to go around.
“I’m not afraid to say the FDA has a whole lot of work to do,” Porter said.
Rep. Lisa McClain (R-Mich.) agreed. She said the committee was looking for answers and solutions.
“The American people are tired of excuses,” she said.
Yiannas testified that a whistleblower had outlined problems at the Abbot Nutrition plant in a 34-page letter sent by mail, by Federal Express delivery, and electronically.
The complaint described a facility with old, damaged equipment and lax safety protocols that hadn’t seen an FDA inspector in at least two years. The whistleblower also told of a previously contaminated batch that had been destroyed before it left the plant. That was never reported to the FDA, according to Yiannas.
Because of the FDA’s “siloed organizational structure and culture,” Yiannas said he didn’t see the warning until at least two infants had died from the contaminated formula. The Abbot Nutrition plant was closed for several months to address the problems once the FDA knew about them.
Lurie pointed out that the shuttered plant produces about 40 percent of all powdered infant formula in the country.
Porter said the fact that three companies have about 90 percent of all baby formula in the United States is a problem.
The witnesses told the committee that steps had been taken to deal with the problems and prevent future shortages but that more needs to be done.
In the wake of the crisis, FDA Commissioner Dr. Robert Califf announced a restructuring of the organization to include a “Human Foods Program.” Focused on food safety and supply, the program would be led by a deputy commissioner reporting directly to the commissioner.
The new deputy commissioner would have decision-making authority over policy, enforcement, and regulation writing within the program.
Yiannas said another problem is that the bacteria that caused the problem, Cronobacter sakazakii, isn’t “nationally reportable.” This means that producers aren’t required to report finding this in a product that doesn’t leave the plant. He said this must change.
Lurie noted that $12 million had been set aside for nutrition, which he said is a good step but not enough.
“A figure closer to $24 million is needed to adequately fund this work,” he said.
Yiannas resigned over the shortage last January. At the time, he said he had delayed his resignation until after implementing steps to address the problems he found. Both men said the issues haven’t been resolved and warned that more shortages are possible if changes aren’t made.
McClain said it’s true that Abbot Nutrition is ultimately responsible. However, she pointed out that the company is being called to account by government agencies, law enforcement, and various civil lawsuits.
McClain said the FDA failed in its responsibility to keep Americans safe and is now seeking $372 million “for not doing its job.” She said Congress would act on the FDA’s failures.
“The FDA needs to be held accountable for its lack of transparency to the Congress and the American people just as we are holding Abbot accountable,” she said.
