Ex-FDA Official: ‘Slow’ Action Led to Formula Shortage

Former Food and Drug Administration food policy official Frank Yiannas told a Congressional oversight committee Tuesday that the agency’s slow action and failure to adequately monitor the food chain supply during the COVID-19 pandemic led to the current shortage of baby formula, the Washington Post reported.

“Even as COVID-19 created the biggest challenge to the food system in 100 years, there was internal debate at the agency on whether there was really a role for the FDA in monitoring food supply chains,” the news outlet reported he said in his prepared remarks in front of the House Oversight Committee.

Yiannas, who resigned his position at the agency earlier this year because of the agency’s “shortcomings,” said the FDA was “slow to act” following the closure of Abbott Nutrition’s Sturgis, Michigan, factory amid sanitation concerns, which significantly decreased the U.S. supply of baby formula, and failed to adequately monitor the food supply chain for deficiencies brought to light during the pandemic, due to the agency’s structure and internal culture, the report said.

“I believe that the literature of the future will also conclude that this incident is a sad example of how FDA’s siloed organizational structure and culture impeded rapid critical problem identification, communication and response,” Yiannas said.

PBS reported in February that the shortage of formula is now in its second year and has expanded to needed medicines like children’s Tylenol and Motrin, as well as the antibiotic Amoxicillin.

“At this point, we are seeing supply of formulas start to come back to shelves. But if you’re a parent in most parts of the country and you’re finding that those shelves are still pretty bare, and what we’re seeing is sort of this mix match of pockets of the country where that shortage is more acute and other areas where it has come back significantly,” The 19^th News economy reporter Chabeli Carrazana told PBS on Feb. 25. “Just this week, we saw some more formula recalled from Enfamil, which the FDA is saying, will hopefully not worsen the situation significantly, but it’s definitely still a huge problem.”

In addition, Carrazana said that “demand” for certain child medicines ramped up during this year’s flu season, causing some shortages in the country.

“We have heard from Johnson & Johnson, who’s the main manufacturer of these medications, that this cold flu COVID-19 RSV season from the fall really ramped up the demand for these medications,” Carrazana said in the report. “We had people who were buying them proactively, and so now we are seeing parents buying alternatives, generics, different forms. I think that situation is getting a little better, but it’s still definitely with us as well.”

Other officials at the FDA are also leaving the agency, including Center for Food Safety and Applied Nutrition Director Susan Mayne, who announced her retirement Monday, according to the Post.

“[It is] necessary that FDA look critically at the broader foods program structure, to reduce redundant operations, increase efficiencies and make optimal utilization of our field resources,” she said in her announcement.

The Post’s report said FDA Commissioner Robert Califf is scheduled to testify in front of the committee on Wednesday.