The country’s lack of infant formula is unlikely to be fully addressed by the end of July, the head of the Food and Drug Administration (FDA) told senators on Thursday.
During a Senate medical committee hearing, FDA Commissioner Robert Califf said it would take a while to get to the point where store shelves were fully stocked, but that there would eventually be a surplus.
“I expect that within two months we should be beyond normal and in abundance,” Califf said. “It will probably be a gradual improvement somewhere around two months before the shelves are full again.”
Califf added that there would be a need to discuss whether the government should create a national recipe stock “as a backup” to protect itself from future disruptions.
“I think we’re going to have to have a surplus.” We definitely plan to have a surplus. The question is, should we maintain this surplus as government activity for the foreseeable future? Califf said.
The Senate hearing was the second in so many days that Califf testified to frustrated lawmakers about the agency’s actions related to the pattern crisis.
During a hearing in the House of Representatives on Wednesday and again in the Senate on Thursday, Califf admitted that the agency was too slow to respond to reports that infants had been hospitalized after consuming artificial nutrition produced at the Abbott Nutrition plant in Michigan.
The plant was closed in mid-February after an FDA inspection found unhygienic conditions and numerous strains of bacteria that could be fatal to infants.
Four infants were hospitalized and two died after becoming infected with the bacteria. But the FDA has not been able to convincingly link the bacteria found in Abbott’s plant to strains found in sick children.
Abbott is one of only four companies responsible for an estimated 90 percent of the US recipe market. When Abbott’s plant closed, the effects came down on the supply chain, which was already so strained by the coronavirus pandemic.
The FDA and Abbott operate under a legal agreement to reopen Abbott’s facilities, but there have been conflicting statements about when this might happen.
Executive Abbott told the House panel on Wednesday that the company is ready to reopen early in the first week of June.
But Califf said the company still has to meet lengthy FDA requirements and will not be ready in the next few weeks.
“Our oversight is critical, but make no mistake: A return to normal will only happen if Abbott takes steps to restore in a safe way,” Califf said on Thursday.
“I think Abbott would agree with us that they are 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 where bacteria grow, ”Califf said.
“Would you go to the kitchen if bacteria grew everywhere, still water and people penetrated the mud on their feet? Which basically showed the inspection, “he added.
Califf also defended the agency’s reports of shortcomings on Thursday, saying he did not think it was necessary to warn Americans earlier about a potential shortage or disruption of the supply chain.
“We monitored the supply. About a month ago there were problems, but they were manageable for a large number of people. And then things quickly turned into empty shelves. That’s when we really revived the public road, “Califf said.
“There were concerns that if there had been a lot of public communication before and things were manageable, it would be understandable that families could buy more than they needed to be safe,” Califf said.