Healthcare

Top FDA official says he didn’t see whistleblower’s baby formula plant complaint for four months

A top official at the Food and Drug Administration (FDA) said in an interview published Wednesday that he did not see a whistleblower’s complaint regarding Abbott baby formula until four months after it had been sent.

“It wasn’t sent to me and it wasn’t shared with me internally. How does this happen?” Frank Yiannas, the deputy commissioner for food policy and response at the FDA, said to The Washington Post. “There were early signals, and in any safety profession you want to take those seriously to stop the domino effect. That didn’t happen.”

The report was made by a former quality assurance worker who sent out their report in October and alleged that Abbott had removed some baby formula from its distribution after learning that microorganisms had been positively tested for in a batch of baby formula, according to the Post.

However, other batches of baby formula that did not undergo additional testing had been released for distribution, according to the whistleblower. Management at Abbott were reportedly nervous that an FDA inspection at a facility of theirs in Sturgis, Mich., in 2019 would raise concerns about the issue.

“Why didn’t we act more quickly on the complaints and the whistleblower report? Who knew what when?” Yiannas told the newspaper. “Those are going to be some of the tough questions that will have to be answered.”

Yiannas later ended the conversation with the newspaper after claiming he did not know he was speaking with a reporter, though the Post noted that a voicemail had been left that included the nature of their story, the reporter’s name and position. 

The Post also noted that the FDA had conducted an inspection of the Michigan facility in 2019, in which inspectors found that formula produced there had not undergone adequate pathogen testing and that cronobacter, a deadly pathogen, had been found in the finished products. 

The newspaper noted that the agency did not return to the plant until 2021, and that the Abbott plant had not been issued any restrictions following the 2019 inspection.

In February, Abbott said several of its baby formulas were being recalled following the hospitalization of four babies who had used Abbott’s products. 

A spokesperson for the FDA disputed some of the claims Yiannas made during his interview with the Post, including that he had been told to “stand down” by then-acting FDA Commissioner Janet Woodcock after beginning work on a corrective action plan for Abbott. 

“To clarify, Dr. Woodcock did not tell Mr. Yiannas to stand down. The corrective action plan in question is outlined in the consent decree entered by the Department of Justice on 5/16/22. Further, Dr. Woodcock is not leading efforts to outline what Abbott must do to reopen the facility,” the FDA spokesperson said in a statement.

The FDA spokesperson also disputed Yiannas’s claim that he was continuing to be excluded from the Abbott facility’s FDA oversight, telling The Hill, “To clarify, since April 1, 2022, Frank Yiannas has served as the head of an Agency-wide Incident Management Group to manage the infant formula response, including resumption of operations at the Sturgis facility and other supply chain issues.”

Additionally, the FDA spokesperson referred The Hill to testimony offered by the FDA during a House subcommittee hearing on Wednesday, which outlined the agency’s response to the whistleblower complaint. 

According to the timeline offered by the agency, the FDA received a complaint from a “confidential informant” on Oct. 21, 2021, which the testimony said “is reviewed by multiple FDA staff. FDA acknowledges receipt. FDA begins planning for an inspection at Abbott Nutrition’s Sturgis facility.”

The FDA testimony said a hard copy of the complaint from a confidential informant was received at a Detroit office but noted that “FDA leadership do not receive direct copies of the complaint due to an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues.”

The FDA testimony indicated Yiannas was not among the FDA officials who received the complaint after it was sent, but showed that the agency interviewed that informant in December 2021. 

An Abbott spokesperson said in a statement that there was “no conclusive evidence” that the infant illnesses are tied to Abbott’s baby formula

“All retained product tested by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter sakazakii and/or Salmonella. No Salmonella was found at the Sturgis facility,” an Abbott spokesperson said in a statement. 

“The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the facility and has not been linked to any known infant illness.”

Abbott also claimed that the whistleblower was a former employee who had been dismissed “due to serious violations of Abbott’s food safety policies.”

“After dismissal, the former employee, through their attorney, has made evolving, new and escalating allegations to multiple authorities,” the company added in their statement

Updated May 26 at 8:42 p.m.

Tags Janet Woodcock

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