Hearing Wrap Up: Former FDA Official: Infant Formula Crisis Was “A Preventable Tragedy”

WASHINGTON—The House Committee on Oversight and Accountability Subcommittee on Health Care and Financial Services held a hearing today titled “FDA Oversight Part 1: The Infant Formula Shortage.” At the hearing, subcommittee members asked Frank Yiannas, Former Deputy Commissioner of the Food and Drug Administration (FDA) about the FDA’s failure to respond to the infant formula crisis. Members asked Mr. Yiannas about how the FDA failed to heed to whistleblowers, respond quickly, conduct an objective review, and take ownership of the crisis.

Key Takeaways:

The FDA failed to conduct adequate inspections and ignored a whistleblower report of a Cronobacter sakazakii bacteria outbreak in Abbott Nutrition’s powdered infant formula production facility for months.

The FDA failed to conduct adequate inspections and ignored a whistleblower report of a Cronobacter sakazakii bacteria outbreak in Abbott Nutrition’s powdered infant formula production for months.

• In his opening testimony, Mr. Yiannas said, “As we all now know, FDA’s response to a series of reports of multiple infants infected with Cronobacter, along with the letter received from a whistleblower, spanned a period of several months beginning in September of 2021. It wasn’t until January 31^st of the following year – four months later – that the FDA began an official inspection of the Abbott Sturgis facility. Had the agency responded quicker to some of the earlier signals, I believe this crisis could have been averted, or at least the magnitude lessoned.”

The FDA’s dysfunction and decentralized structure created a nationwide formula crisis.

• “There is no question that FDA’s siloed and decentralized foods program structure and culture contribute to and exasperated these delays,” said Mr. Yiannas.
• Mr. Yiannas also testified how the FDA prioritizes its drug program over the food program.

The FDA has not taken the actions needed to prevent a similar crisis from happening again.

• Mr. Yiannas testified, “It is my view that the state of the infant formula industry today is not much different than it was then. The public health surveillance system for this pathogen remains insufficient, the necessary safeguards have not been advanced at an adequate pace to prevent future illnesses, and the infant formula supply chain continues to lack serious resiliency. In other words, the nation remains one outbreak, one tornado, flood, or cyber-attack away from finding itself in a similar place to that of February 17, 2022.”
• “The infant illnesses and deaths due to Cronobacter, the Abbott recall, and the cascading and devastating effects it had on infant formula availability and families in our country was all a preventable tragedy,” Mr. Yiannas said, concluding his opening testimony.

Oversight Republicans will hold the FDA accountable and find solutions to prevent a similar crisis from happening again.

Member Highlights:

Rep. Glenn Grothman (R-Wis.) asked about the FDA’s decentralized foods program structure, which FDA officials have stated on the record prioritizes the agency’s resources and budget on the drug program over the food program.

Rep. Grothman: “Would you describe the current structure as decentralized?”

Mr. Yiannas: “Absolutely.”

Rep. Grothman: “Do you think that is a problem where it is decentralized if you have a crisis, like we had last year?”

Mr. Yiannas:“I do. I think the decentralized and distributed nature of the organization caused information silos, not allowing critical data and information to flow to those that needed it quickly and that needed it most.”

Mr. Yiannas continued: “My experience in decisions that have been made, including financial ones on supply chain monitoring, food has taken a backseat to drugs.”

In response to Rep. Anna Paulina Luna (R-Fla.)’s question about the FDA’s delayed response to investigate a Cronobacter outbreak, Mr. Yiannas pointed out that other inspectors in the food safety profession conducted inspections throughout the pandemic, while the FDA failed to act.

Mr. Yiannas: “The FDA developed an internal policy that it would monitor COVID transmission around the country and if it was above a certain level, they would not do inspections even though they were deemed critical.

“If you looked at other segments of the food safety profession, USDA inspectors continued to show up. They were considered critical infrastructure. If you look at many of the states, state inspectors continued to show up. I think that’s a fair conversation to have. Heaven forbid there’s a future pandemic, are FDA inspectors critical personnel and critical infrastructure?”

“We also need to fully explore other means to gather intelligence, whether it’s remote access of data and records,” Mr. Yiannas added.

Rep. Nick Langworthy (R-N.Y.) inquired about the cause for the four-month delay in the Deputy Commissioner and Acting Commissioner at the FDA receiving whistleblower complaints.

Rep. Langworthy: “What did the FDA blame this delay on?”

Mr. Yiannas: “Several things. Initially, as you heard in the original congressional hearing, there was a lot of focus and discussion about mail rooms, and that the mail rooms lost it. That whistleblower complaint was sent by FedEx — hard copies — to multiple individuals and multiple offices.

“Allegedly, it was lost in the mailroom. We do know that some individuals received copies by emails, and in hindsight those should have been escalated to my office very rapidly. Those were some of the reasons that were reported.

Mr. Yiannas discussed with Chairwoman Lisa McClain (R-Mich.) that the FDA did not conduct an independent, objective review of the crisis.

Rep. McClain: “In your opinion does the Solomon report objectively evaluate the FDA’s response to the infant formula shortage?”

Mr. Yiannas: “A couple of things that I’ll say. One, it was not independent. It was created internally by FDA. Whenever a crisis of this magnitude happens, it’s good to have some independence.

“Number two, I think you’ve already heard comments, it was presented at a very high level and doesn’t get to really root issues to understand what really happened. I would just ask you to compare my written testimony compared to the Solomon report and say did you learn new things that were a little bit more detailed? I don’t think it went far enough, deep enough, and that it offered the appropriate solutions.”

Mr. Yiannas: “When the crisis first happened, since the fact that I wasn’t notified on February 10^th, and my office was the office of food policy and response, I immediately wanted to know ‘How could something like this happen?’ and ‘What could we do to prevent it from ever happening again?’ And so, I asked all program components to start developing a timeline, but shortly thereafter the principal deputy commissioner [then acting Commissioner Janet Woodcock] and the chief of staff told me that they would develop the timeline, and shortly thereafter we learned that the principal deputy commissioner would write the report or create the report.”