Healthcare

Formula shortage won’t end until July, FDA chief says

Food and Drug Administration Commissioner Robert Califf testifies during a Senate Committee on Health, Education, Labor and Pensions hearing on the nationwide baby formula shortage on Capitol Hill in Washington, Thursday, May 26, 2022. (AP Photo/Jose Luis Magana)

The nation’s infant formula shortage likely won’t be fully resolved until late July, the head of the Food and Drug Administration (FDA) told senators Thursday.

During a Senate Health Committee hearing, FDA Commissioner Robert Califf said it will take time to get to the point when store shelves are fully stocked but that eventually there will be a surplus.

“My expectation is that within two months we should be beyond normal, and with a plethora,” Califf said. “It’s going to be gradual improvement up to probably somewhere around two months until the shelves are replete again.” 

Califf added that there will need to be a discussion about whether the government should create a national stockpile of formula “as a backup” to guard against future disruptions.

“I think we’re going to have to have a surplus. We’re certainly planning to have a surplus. The question is, should we maintain that surplus as a government activity for the foreseeable future?” Califf said.

The Senate hearing marked the second time in as many days Califf testified to frustrated lawmakers about the agency’s actions related to the formula crisis. 

During a House hearing on Wednesday and again in the Senate on Thursday, Califf admitted the agency was too slow to respond to reports that infants were being hospitalized after consuming formula that was manufactured at Abbott Nutrition’s plant in Michigan. 

The plant was shut down in mid-February following an FDA inspection that found unsanitary conditions and multiple strains of a bacteria that can be deadly to infants. 

Four infants have been hospitalized, and two died, after being infected with the bacteria. But the FDA has been unable to conclusively link the bacteria found in Abbott’s plant to the strains found in the sick babies. 

Abbott is one of only four companies responsible for an estimated 90 percent of the U.S. formula market. When Abbott’s plant shut down, the effects cascaded down a supply chain that was already strained because of the coronavirus pandemic.

The FDA and Abbott are operating under a legal agreement to reopen Abbott’s facility, but there have been conflicting statements about when that might happen.

An Abbott executive on Wednesday told a House panel that the company is ready to reopen beginning the first week of June.

But Califf said the company has yet to meet the FDA’s lengthy requirements and won’t be ready for the next several weeks.

​​”Our oversight is critical, but make no mistake: The return to normal will only take place when Abbott takes steps to resume in a safe manner,” Califf said Thursday. 

“I think Abbott would agree with us that they’re not ready to open. They had to replace the roofs, replace the floors, and they’re still not done. You just can’t reopen a plant with bacteria growing in it,” Califf said.

“Would you go in a kitchen if there were bacteria growing all over the place, standing water, and people tromping through with mud on their feet? Which is essentially what the inspection showed,” he added.

Califf on Thursday also defended the agency’s messaging about the shortages and said he didn’t think it was necessary to warn Americans earlier about potential shortages or disruptions to the supply chain.  

“We were monitoring the supply. Up until about a month ago, there were issues but they were manageable for the vast amount of people. And then things turned to empty shelves very quickly. That’s when we really revved up the public communication,” Califf said. 

“There were concerns that if there was a lot of public communication before that, when things were manageable, that it would be understandable that families might purchase more than they needed to be safe,” Califf said.

Tags Abbott Nutrition baby formula shortage fda Robert Califf Robert Califf
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