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2 House subcommittees are trying to get answers about the baby formula shortage


A shortage of baby formula remains a challenge for families across the U.S. Lawmakers held hearings today to try to understand how this shortage happened and why the federal government didn't act sooner.

NPR pharmaceuticals correspondent Sydney Lupkin is here to tell us about that. Hi, Sidney.


PFEIFFER: Would you remind us what drove this shortage in the first place?

LUPKIN: Sure. As several lawmakers pointed out today, just three companies control 95% of the formula market. So the closure of one factory had a huge impact. Abbott's Michigan factory shut down and issued a recall in February after several babies became ill and two of them died of infections from a bacteria called Cronobacter. The factory has been offline ever since, though it's working with government officials to get restarted safely. They're aiming for the first week of June. Abbott testified today.

PFEIFFER: And what did Abbott say?

LUPKIN: Well, here's Abbott executive Christopher Calamari.


CHRISTOPHER CALAMARI: The current infant formula shortage is heartbreaking. On behalf of everyone in Abbott, I want to express our extraordinary disappointment about the shortage. We are deeply, deeply sorry.

LUPKIN: He talked about what the company is doing to fix things to make sure the issues won't happen again. But when asked about whether there was a culture problem at the plant that hurt quality, he said no. The company's written testimony also emphasized that the bacteria that made the babies sick didn't match the samples of bacteria the FDA found on surfaces in the factory during its inspection.

PFEIFFER: So if the bacteria samples didn't match, does that mean the factory did not make the baby sick after all or that's unclear?

LUPKIN: So according to the FDA, Abbott is in no way off the hook. Here's Susan Mayne, who directs the FDA's Center for Food Safety.


SUSAN MAYNE: We can't rule in or rule out whether or not those infants - their Cronobacter was caused by this plant. The data just simply can't be used to inform it.

LUPKIN: The FDA didn't have factory samples from when the formula was made that these babies consumed before they got sick. The inspection didn't start until the end of January, but the first report of a sick child reached the FDA back in September. And an Abbott whistleblower contacted the agency in October alleging unsanitary conditions, falsified records and other major problems, but the FDA didn't talk to them until late December.

PFEIFFER: They got the tip in October, contacted them in December. What took so long?

LUPKIN: That was really the million-dollar question when legislators grilled FDA officials. Here's Representative Jan Schakowsky of Illinois.


JAN SCHAKOWSKY: I'm actually pretty furious about the FDA's lack of food safety leadership, communication and action.

LUPKIN: FDA Commissioner Robert Califf acknowledged that it was too slow. And he used a vivid analogy to describe what the agency found at the plant.


ROBERT CALIFF: Let's say you had a next-door neighbor who had leaks in the roof. They didn't wash their hands. They have bacteria growing all over the kitchen. You walked in and there was standing water on the counters, and the floor and the kids were walking through with mud on their shoes, and no one cleaning it up. You probably wouldn't want your infant eating in that kitchen.

LUPKIN: He says FDA has been doing what it needed to do to get the plant back on track since then.

PFEIFFER: That's NPR's pharmaceuticals correspondent Sydney Lupkin. Sydney, thank you.

LUPKIN: You bet. Transcript provided by NPR, Copyright NPR.

Sydney Lupkin is the pharmaceuticals correspondent for NPR.