FDA refuses to tell Congress why infant formula response took months

FDA Commissioner Robert Califf refused to answer questions from lawmakers Thursday about why it took the agency months to respond to reports of infant illnesses and a whistleblower complaint regarding the infant formula plant at the heart of the current formula shortage.

“We have an ongoing investigation about the details of exactly what happened, from point A to point B along the way, and since it is ongoing, I can't give extensively more details on that part of it,” Califf said during a House Appropriations subcommittee hearing.

As POLITICO first reported, the agency’s lag in action spans several months. FDA was told of the first infant hospitalization linked to formula made at an Abbott Nutrition plant in September. Top agency officials were sent a detailed whistleblower document in October, which alleged that the plant, in Sturgis, Mich., had poor food safety practices and that officials there had falsified documents and intentionally hid things from FDA inspectors. The FDA did not interview the whistleblower until December.

Three more reports of infant hospitalizations, including two deaths, were reported to FDA before the agency inspected the plant in late January, when inspectors found major food safety problems and five strains of Cronobacter sakazakii, the bacteria that had sickened the four infants, though the strains of bacteria found at the plant did not match the two cases the government was able to test. FDA also found Cronobacter in an opened can of formula, which didn’t match the plant strains. A sweeping recall was issued in mid-February.

In a consent decree this week, the government said it had determined infant formula products at the plant had been “adulterated because they were made under insanitary conditions and in violation of current good manufacturing practice requirements.”

Califf did not dispute the agency’s lengthy timeline Thursday. “The dates are well known,” he said. “The information is in the public.”

But when lawmakers pressed for an explanation, the commissioner refused to give one.

Rep. Mark Pocan (D-Wis.) was not happy about the lack of answers.

“It's not acceptable to say that you can't comment on it,” Pocan said. “The public wants to know.”

“One problem that I've seen over and over with the FDA, in my 10 years here, is you guys aren't good at communicating,” he added.

Califf’s refusal to answer questions from Congress comes as Washington intensifies its response to a shortage of infant formulas. President Joe Biden on Wednesday went as far as invoking the Defense Production Act and announcing that the Defense Department will help fly formula to the U.S. from abroad. A senior administration official on Thursday declined to say why Biden didn’t invoke the DPA, a wartime power used to prioritize the production of certain goods, months ago or what triggered the White House to invoke the measure now, days after a White House spokeperson suggested the measure wouldn’t be effective for a product as specialized as infant formula.

House Appropriations Chair Rosa DeLauro (D-Conn.) shredded the government’s response Thursday, placing specific blame on FDA for taking months to act and ultimately recall products.

“How many more illnesses and deaths were caused due to the FDA slow response?” DeLauro asked, adding: “Why was there no reaction? It makes me question which side the FDA is on. Are they on the side of Abbott and industry, or are they the side of the American consumer, in this case babies and their moms and dads?”

“You can’t hide behind an investigation,” DeLauro said. “We need answers. We need them now.”

DeLauro pressed Califf about the FDA’s timeline for its response and asked who was handling the infant formula response when the whistleblower warned senior FDA officials of food safety concerns about the Abbott plant in Sturgis last fall.

“As I’ve said, you’ve got the timeline down and you’ve got the key issues,” Califf replied. “I know we have an Oversight hearing next week and we’ll be prepared to go into much more detail at that point. As I’ve said, we could do better than we did.”

Califf later said he’d provide DeLauro with answers, but he didn’t currently have them. Lawmakers also expressed concerns about the fact that FDA principal deputy commissioner Janet Woodcock — who was among the officials who received a copy of the whistleblower report in October — has been charged with reviewing the agency’s response to the infant formula.

“That is the fox in the henhouse,” DeLauro said of the arrangement.

Califf on Wednesday announced that Woodcock, a longtime veteran on the drug side of the agency, would be taking a greater role on food issues at FDA, something that infuriated consumer advocates and industry leaders. 

The White House has also ducked questions about the timeline for the administration’s response. Asked by POLITICO this week about when the FDA told the White House of the issues at the Sturgis plant and any concerns about potential shortages, a senior administration official said they would not comment on “internal communications.”

“The recall became public on February 17 and we certainly have been very public about our activity in this space since then,” the official added.