At that time, FDA officials held a briefing with White House staff to discuss the situation, as an Abbott plant in Sturgis, Michigan, was still closed and continued to be plagued with problems. In that meeting, the details of which have not previously been reported, FDA officials focused on lingering issues with the shuttered facility — including why it remained so difficult to bring it back online — using a highly technical language. Since Abbott controlled about 40% of the formula market, the closure of the plant heralded serious problems.
Notably missing from the agency’s presentation that day, sources familiar with the discussion said, was the focus on the depth to which Abbott’s troubles could wreak havoc on the national milk supply chain. mothered.
“Early May is when we really start trying to roll up our sleeves and figure out what’s going on here,” a senior administration official recalled in an interview with CNN. “It was a time when I think a lot of people in all these kinds of conversations were like, ‘We all think we should do a few more things now. “”
Interviews with current and former administration officials, including about that FDA-White House meeting in May, offer insight into two questions that have haunted the Biden administration: why the White House did not intervene with his own emergency actions until the formula shortage seemed to have become a full-fledged crisis and why President Joe Biden was not told of the seriousness of the situation until months after the shutdown of the Abbott factory. Former FDA employees also painted a picture of deep-rooted issues at the agency that may have hampered its understanding of a potential formula shortage heading its way, as well as the speed of the administration’s response. .
Weeks after the mid-spring discussion between FDA and White House officials, Biden would invoke the Defense Production Act to ramp up formula production at home and announce multiple flights to bring in large amounts of milk. baby food from abroad. He would also hold meetings with executives from major retailers and formula makers.
But for parents and caregivers across the country, those actions in May seemed to come far too late.
At that time, the domino effect triggered by the closure of the Michigan Abbott plant was becoming more visible to consumers with each passing day, as parents and caregivers rushed to get baby food. . Critics and questions about the Biden administration’s handling of the situation were also growing louder.
“They did, but not me”
The president then made a stark admission: Unlike those leaders, he didn’t realize the seriousness of the formula shortage until months after Abbott’s reminders.
“They did, but I didn’t,” Biden said. “I became aware of this issue sometime in – after April – early April, how intense it was.”
The president added: “So we did everything we could from then on, and that’s all I can tell you at the moment.
The comments raised new questions about the federal government’s handling of the formula problem, especially since White House officials had repeatedly insisted the administration had been working around the clock since February. to remedy the situation.
When the issues with Abbott Michigan became public knowledge in February, the administration began tracking national infant formula inventory levels as well as sales data, sources familiar with CNN told CNN.
Here’s what they saw in these trends: In March, there was a significant drop in the availability of formulas on store shelves, suggesting that many items were out of stock. But that appeared to level off in April, which officials interpreted to mean that the first round of action by the FDA and USDA to speed up formula production and loosen the rules around which formula families were allowed to buy through a federal nutrition program were to start helping.
But in May, the in-stock rate started to fall again.
Meanwhile, the sales data the administration was tracking told a different story: Infant formula purchases remained broadly at year-ago levels through March and April. Officials understood that to mean that during those months, families could still get their hands on the formula they needed, even if some products might be missing from store shelves. However, these products probably sold out quickly and didn’t stay on store shelves long before they were picked up.
But that, too, began to change in May, with the administration seeing a noticeable increase in sales levels.
“All of a sudden you see a high buying pattern emerging the first two weeks of May, that’s when we all start to realize that something new is happening in the market and we start to suspect that all of a sudden there’s a demand shock that’s hit,” the senior administration official said.
The confluence of declining shelf availability and rising sales figures was a bright red flag, the manager noted: “We wanted to get ahead of what we feared would add new pressure to the supply chain. supply at that time.”
This new concern in May could help explain why Biden said he was not made aware of the seriousness of the formula shortage until sometime “after April.” White House press secretary Karine Jean-Pierre deflected many questions from reporters about why he hadn’t been briefed until then and which of his advisers eventually briefed him.
An agency ill-equipped to predict food shortages
“The FDA has been a critical partner in the President’s goal to accelerate the availability of safe infant formula, but ultimately it will be up to Abbott to end this shortage,” a House official said. Blanche in a statement to CNN.
Part of the reason for this, former FDA officials told CNN, is the lack of resources and data provided to the branch of the FDA that tracks food.
The FDA monitors food and drugs, but former officials said food oversight was less sophisticated at the agency than on the drug side, and the agency was simply not equipped to predict. potential food shortages. It is important to note that infant formula is a food.
In the event of a potential closure of a drug manufacturing plant, for example, the FDA has authorities that allow it to understand the ramifications of the supply chain and, therefore, the possible problems that could arise related to the access to specific drugs if a facility is closed, former officials said.
The FDA has asked Congress to expand those authorities, dating back to 2020 when the agency sought to better understand supply chain issues.
FDA Commissioner Dr. Robert Califf publicly acknowledged these problems during a Senate committee hearing in May.
“We have almost no authority now other than to review products as they come in,” Califf told lawmakers.
“There is no longer an obligation now for companies to notify us when they have an impending shortage. There is no obligation unless they find a contaminant in a sample from their facility that has not yet been shipped, they have to let us know,” Califf said, pointing out that Abbott had detected cronobacter in samples of his formula, but did not tell the agency.
The FDA launched a review of its actions leading up to the shortage, but in a statement to CNN argued that the agency kept its federal partners appropriately informed throughout the year.
“The FDA worked to resolve the infant formula supply chain issues before and after the recall and kept our federal partners such as the USDA, HHS, and the White House informed of our concerns and our efforts to mitigate these challenges throughout this period,” an FDA spokesperson said.
“These interactions included the clear communication of our concerns regarding infant formula supply chain issues associated with the pandemic and the far-reaching impact that the recall and closure of a facility of America’s largest infant formula supplier would have on the market,” the spokesperson added.
The Michigan plant reopened on June 4, after a federal judge signed an agreement between the FDA and Abbott.
But last week the company halted formula production again after severe storms caused flooding in the city, including inside the factory.
“It’s disappointing,” said Jean-Pierre when asked about the latest setback. “What we can do is continue to focus on what we are going to do, which is to increase production, increase supply and ensure that American families only have access to safe formula. That’s our goal. That’s what we control.”