Babies should not suffer projectile vomiting and die from drinking contaminated infant formula made by ABBOTT.
FDA's Deputy Commissioner, a former Wal-Mart manager, claims he did not read the baby formula whistleblower's report until four months late.
Government safety rules don't work we'll when you hire corporate hacks.
Governments must learn to listen, respect and honor whistleblowers.
Enough flummery, dupery and nincompoopery from FDA.
Congressional hearings should expose the whole truth. Now.
From The Washington Post:
Whistleblower report on baby formula didn’t reach top FDA food safety official
A report alleging safety failures at a plant took four months to reach Frank Yiannas, the top food safety official
By that time, one infant had already died and two others were hospitalized after consuming formula from the plant — all while other top FDA officials less-versed in food safety had elected not to send new inspectors to the plant in Sturgis, Mich. As another infant death was linked to Abbott-produced formula, the plant closed down and a recall was issued, sparking a critical national shortage of baby formula.
The national fallout over the Abbott case has exposed a fractured structure at an agency that has long prioritized drugs and medicine over food safety, experts say — a problem exemplified by its handling of the whistleblower complaint and other warning signs of problems at the plant.
Neither of the FDA’s food policy divisions has to report to Yiannas, and neither do the agency’s food safety inspectors. Instead, they report directly to FDA Commissioner Robert M. Califf, a physician who was appointed to the top post on Feb. 17, the day Abbott recalled many of its powdered products. Before Califf was appointed, food safety problems were reported directly to Principal Deputy Commissioner Janet Woodcock, another physician who was acting commissioner when the whistleblower complaint arrived.
“The essential thing is that you’ve got three major operating components that are reporting only to the [FDA] commissioner, who, by tradition and current reality is a physician who is focused on medical products and doesn’t have the bandwidth or the inclination to spend time providing the leadership that’s needed for the food program to be successful,” said Michael R. Taylor, who was deputy commissioner for foods and veterinary medicine during the Obama administration.
On Wednesday, two House committees will hold separate hearings to investigate the agency’s actions in the Abbott case as well as whether there are deeper structural problems in the agency.
“Why didn’t we act more quickly on the complaints and the whistleblower report? Who knew what when?” Yiannas said. “Those are going to be some of the tough questions that will have to be answered.”
Yiannas spoke to The Post after calling back a reporter who stated their name, title and the nature of the story in a voice mail; after repeatedly addressing the reporter by name, Yiannas later terminated the conversation and claimed he did not realize he was speaking to a journalist.
In a statement on Tuesday, an FDA spokeswoman declined to comment on Yiannas’s claim about a lag of months in learning of the whistleblower’s report. She said that Califf will testify in the hearings about the agency’s response to the formula crisis.
“Once the immediate public health risk is minimized, the FDA will conduct a programmatic review to ensure the maximum effectiveness of agency programs and policies related to infant formula and special medical food complaints, illnesses and recalls,” the spokeswoman wrote.
Abbott said there is not clear evidence that the contamination affecting babies originated at its plant. “After a review of all available data, there is no conclusive evidence to link Abbott’s formulas to these infant illnesses,” the company said in a statement.
Organizations representing consumers, the food industry and state food regulators are pushing to restructure the FDA. In April, the groups sent a letter to Califf, calling on him to unify the entire FDA food program under Yiannas and to maintain that structure with his successors.
Meanwhile, Yiannas said he continues to be cut out of the FDA’s oversight of the Abbott facility. He began work on a corrective action plan for Abbott in February but said he was told to “stand down” by Woodcock.
The FDA disputed that Woodcock gave such an order, and also Yiannas’s claim that he hasn’t been given oversight of the facility’s reopening process. The agency said he is managing an agencywide group working to address the formula crisis.
Lawmakers have expressed concern at Woodcock’s role in the FDA as it works with Abbott to address the safety issues to reopen its plant. Rep. Rosa L. DeLauro (D-Conn.) in a hearing called Woodcock — who received the whistleblower complaint and was heading the agency as officials failed to act on it for months — a “fox in the hen house” and said it appeared she was playing a leading position in the Abbott plant review. (The FDA also disputes that Woodcock is overseeing efforts to reopen the plant.)
Tom Neltner, chemicals policy director for the Environmental Defense Fund, who has been working with the agency to eliminate heavy metals from baby foods, said the national formula shortage has been exacerbated because the agency has given authority to officials withouttraining and firsthand experience in the food industry.
“The FDA’s delays on inspection and acting on the whistleblower complaint made the recall so much worse,” he said of the shortage. “They didn’t understand that the Sturgis facility was such a dominant source and that they would need to backfill formula from other sources.”
The Sturgis plant has experienced food safety problems in the past. In September 2010, the company issued a recall of some of its Similac powered infant formula after beetles and beetle larvae were found in the finished formula, which was produced at the plant.
The following month, the FDA went into the plant to investigate and cited the company for several food safety violations and a “failure to manufacture foods under conditions and controls necessary to minimize contamination,” public records from the agency show.
After that, the Abbott facility passed annual inspections for nearly a decade without any serious food safety findings, agency records show.
That changed in 2019. During a routine inspection that year, FDA inspectors learned that Abbott had found the potentially deadly pathogen cronobacter in its finished products. They also discovered plant workers were doing inadequate pathogen testing of formula produced at the plant.
“You did not test a representative sample of a production aggregate of a powdered infant formula at the final product stage and before distribution to ensure that the production aggregate meets the required microbiological quality standards,” the report read.
Inspectors also found the company had received at least 10 complaints from nurses and parents who believed Abbott’s products were making infants sick. One complaint came from a pediatric nurse who said five babies had consumed Similac Sensitive Infant Formula and that “all babies were projectile vomiting,” records show.
In another instance, involving three different Abbott formulas, records show an infant had a seizure and was diagnosed with a bacterial infection from a strain of the cronobacter pathogen.
The children recovered and, in each case, the company said it investigated and determined their products were not responsible, records show.
Despite these findings, the FDA did not issue any restrictions on the plant and closed out the investigation. Inspectors did not return to the plant for two years, records show, and the agency cited the pandemic and the risk of spreading the coronavirus as one of the reasons.
In a statement, the FDA noted that “mission-critical inspections when possible were made on a case-by-case basis. … We can confirm that during the pandemic, the agency conducted a number of inspections of powdered infant formula manufacturers.”
But not at Abbott’s Sturgis facility.
“When you look at the inspection reports, you see FDA not being there during covid, even though they had found serious problems before. That seems crazy, especially for infant formula,” said Bill Marler, a food poisoning attorney who is well known for helping shape federal food safety laws and policies.
Although the FDA is understaffed in its inspection ranks, during the height of the pandemic, the absence of inspectors in food plants was a matter of policy. Woodcock signed off on a work-from-home model for inspectors. Meanwhile, food safety problems mounted at the Abbott facility, records show.
“The untold story is that the FDA took all of their staff out of the field for nearly two years during covid except for ‘emergency for-cause inspections,’” said Steven Mandernach, executive director of the Association of Food and Drug Officials, the organization responsible for the inspections at the state level. “Woodcock said they did all these inspections, but for two years many food inspectors never left their home — the states did them.”
However, Michigan food inspection records show that state inspectors also did not visit the Abbott plant in 2020. The last time they visited was in October 2019, records show.
Mandernach said that during the pandemic, the FDA hired additional staff, but because many of them were stuck at home, inspectors left the agency. “The FDA has had a huge retention problem,” he said, adding that food investigators or inspectors often are paid dramatically less than medical products investigators.
When FDA inspectors ultimately returned to the plant in 2021, they documented a host of new food safety problems at the Abbott plant. Workers were handling raw materials, packing and equipment after failing to properly wash their hands. There was also pitting found in the dryers — nooks and crannies that had developed over the years where bacteria could lodge and grow. The report concluded that Abbott “did not maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition.”
These and other observations were made by FDA inspectors even though the agency had departed from its routine of conducting “surprise” or unannounced inspections during the pandemic. Records show the agency gave the plant several days notice before inspectors arrived.
During their visit, inspectors also learned that Abbott had received 16 complaints from 2019 to 2021 about infants who became ill after drinking Abbott products, agency records indicate. Testing showed it was from bacterial infections, including from salmonella and cronobacter. As with the previous complaints found during 2019 inspection, Abbott said it had determined its products were not responsible.
In the middle of the inspection, the FDA also received its first complaint of a child hospitalized with another bacterial infection from cronobacter sakazakii after drinking formula from the plant.
None of this prompted the FDA to conduct its own testing of the formulas produced at the facility, records show. The complaints that the company received were also not mentioned in the final notice — called a 483 — which would have been reviewed by FDA officials with Abbott management at the close of the inspection. The pitting found in the plant’s dryers was also not mentioned, records show.
“This really hit me between the eyes,” said Phyllis Entis, a food safety microbiologist of 50 years who reviewed the inspection reports. “Here was this great big flashing red warning light in September. They didn’t mention it in the 483. They didn’t do any additional swabbing or testing. They did nothing about it.”
Taylor, the former FDA deputy foods commissioner, said one of the likely reasons the agency did not take more aggressive action when it found problems at the plant is the agency is still operating under an old set of principles.
That was supposed to change when Congress passed the Food Safety Modernization Act in 2011, which aimed to radically shift the FDA to a model that prevents food poisoning outbreaks.
Inspectors were supposed to identify potential food safety problems — and demand corrections — to keep bacterial contamination from spreading in food plants. Instead, Taylor said inspectors continue to take aggressive action mostly in cases in which the company’s conduct has already led to serious food-borne illnesses.
“They still need to shift from this historic reaction to a culture of prevention,” Taylor said. “What happened with the infant formula illustrates that.”
Structural changes made under the Trump administration further hampered communication in the agency, Taylor said. While Taylor was at the FDA, the two divisions for human and animal food products — the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine — reported directly to him. This changed during the Trump administration when then-FDA Commissioner Scott Gottlieb, who did not return calls seeking comment, had the two units report directly to him. This structure has not changed under the Biden administration.
When FDA inspectors failed to return to the Abbott plant, a former quality assurance worker turned whistleblower on Oct. 19 and 20 mailed to several agency officials hard copies of his report, which DeLauro released at a hearing last month.
He claimed Abbott purposefully falsified records, released untested formula, employed lax cleaning practices, misled auditors, failed to take corrective measures and lacked good systems for tracing potentially contaminated products, the report shows.
The whistleblower said that before the 2019 FDA inspection, management authorized the release of some of an infant formula batch that tested positive for microorganisms. After the problem was found, the report alleged, management decided to remove some of formula from distribution but released the rest without additional testing. The whistleblower said that Abbott management was worried that the FDA would find out about the problem during the 2019 FDA inspection and that after the fact, one member of management said she was “amazed” that the FDA was unable to discover what had occurred with the tainted batch.
The former plant worker also described repeatedly bringing up concerns about regulatory violations with management, which he claimsultimately led to his being fired.
An Abbott spokesperson said the company is reviewing the claims in the whistleblower report.
“This former employee was 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,” Abbott spokeswoman Vicky Assardo said in a statement. “Abbott is reviewing this new document and will thoroughly investigate any new allegations.”
The whistleblower report arrived at the FDA weeks after a report that a second infant in Minnesota had been hospitalized after allegedly consuming tainted Abbott formula.
FDA officials did not meet with the whistleblower until sometime in December, according to several people familiar with the case — weeks after receiving the report.
According to FDA testimony released Tuesday night in advance of the Wednesday’s hearing, Califf said the agency planned to inspect the facility early in December, but a covid-19 outbreak at Abbott caused a delay, and that a “failure in FDA’s mailroom” delayed the receipt of the whistleblower’s report by a week.
As a result, the FDA didn’t begin its inspection until Jan. 31. The following day, FDA inspectors collected samples that confirmed the presence of cronobacter at the plant.
By then, one infant had died and two had been hospitalized after drinking formula made at the plant.
“The ignoring of the whistleblower complaint is just stunning to me and underscores the problems with how FDA is structured,” said Marler, the food poisoning attorney. “Everyone got that whistleblower report but Frank Yiannas — that makes no sense.”
On Feb. 17, the FDA issued a warning to consumers to not use certain powered infant formulas produced at the Abbott plant. The same day, the company initiated its first in a series of recalls. And the FDA received its fourth complaint, involving an infant who died in Ohio after drinking formula made at the plant. The cause of death was cronobacter poisoning.
It was also the new commissioner’s first day on the job — eight days since Yiannas first learned of the crisis.
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