Congresswoman DeLauro Details Transmission of Infant Formula Whistleblower Report in Response to FDA’s Claims

"Let me be clear from the start: we are not going to get to the bottom of what went wrong if everyone involved wants to skirt accountability. The FDA dragged its feet in responding to a whistleblower report alleging food safety issues at the Abbott Nutrition plant in Sturgis, MI, and now, they're blaming ‘COVID-19 mailroom issues' as the reason that senior FDA officials and then-Acting Commissioner Janet Woodcock did not swiftly respond to these claims. This excuse is convenient, but not compelling enough.

"Here's what we know. On October 19 and 20, 2021, a 34-page confidential disclosure was sent through FedEx to seven senior FDA officials. Three of those seven officials were also notified of the disclosure via email on October 21, and officials at FDA confirmed receipt of the disclosure in a detailed email the very same day. So why wasn't the disclosure immediately escalated once received via email when the email received outlined specific people it should be forwarded to? Why wasn't the whistleblower contacted by FDA until December? In what is outlined by the testimony, I can attest from documentation that not all people who received the email are acknowledged, so what else are we missing?

"Additionally, the FDA claims the whistleblower had health issues that prevented them from conducting the interview. We have confirmed these claims are exaggerated and have documentation to prove that the whistleblower was accommodating, willing, and able to meet with the FDA to discuss these serious allegations.

"My question for the FDA is a simple one: who is in charge? We need accountability for this delayed response to serious allegations of contamination, not excuses. We need to know why there was a failure to immediately act to protect lives. In the virtual world of email, blaming COVID-19 mailroom issues just isn't enough.

"I applaud the Biden administration for hearing our calls and moving swiftly to rectify the shortage by launching Operation Fly Formula to get safe product back on the shelves from FDA-approved facilities. As I've said before, food is a second-class citizen at the FDA and it's time we deal with the structural issues that gave way to this crisis. In the coming days, I will introduce legislation that aims to do this."

In prepared testimony before the House Energy and Commerce Committee, FDA Commissioner Robert Califf and several senior officials claimed the agency's response to a whistleblower disclosure was delayed due to "COVID-19 mailroom issues" despite the FDA receiving this report via email on October 21.

Chair DeLauro has been closely tracking this issue since Abbott Nutrition first announced the formula recall which has driven the nationwide shortage. She examined the recall at a recent hearing and submitted for the record a report acquired from a whistleblower who worked at the Abbott facility which produces infant formula recalled by the Food and Drug Administration (FDA) in February. She has also requested investigations into the FDA's handling of the Abbott powdered formula recall.