At that time, FDA officials held a briefing to discuss the situation with White House staff as the Abbott plant in Sturgis, Michigan was still closed. did. I was troubled by a problem. At the meeting, where details had not been reported so far, FDA authorities used advanced technical terminology to focus on ongoing issues in the closed facility. Given that Abbott dominated about 40% of the formula market, the closure of the factory caused serious problems.
According to controversial sources, what was particularly lacking in the agency's presentation that day was how seriously Abbott's troubles could hurt the nationwide supply chain for infant formula. It was to emphasize the possibility.
"In early May, we really roll up our sleeves and start trying to understand what's going on here," recalls a senior executive in an interview with CNN. Did. "This was a moment I think many people in all kinds of conversations were saying." We all think we should do a little more now. "
Interviews with current and former executives, including an interview with the May FDA-White House Conference, provide insights into the two questions that have plagued the Biden administration. The lack of formula seems to be in full swing, and why was President Joe Biden not informed of the significance of the situation until months after the closure of the Abbott factory? Former FDA employees also painted a picture of the authorities' deep-seated problems that could have hindered the rapid response of the government as well as the understanding of potential prescribing shortages in progress.
Within a few weeks of mid-spring talks between the FDA and White House officials, Biden enacted the Defense Production Act to speed up formula production at his home and abroad. He will also hold meetings with executives from major retailers and infant formula makers.
But for parents and caregivers across the country, these actions in May seemed too late.
By that time, the domino effect caused by the closure of the Michigan Abbott factory will focus on consumers day by day as parents and caregivers scramble to procure baby food. It came to be. There was also growing criticism and questions about the Biden administration's response to the situation.
'They did, but I didn't'
After that, the president gave an impressive approval. Unlike these executives, the president was unaware of the seriousness of the official shortage until a few months after Abbott recalled.
"They did, but I didn't," Biden said. "This problem became aware of its seriousness in early April after April."
The President added: "So we are from that point on. I did everything by force, and that's all I can tell you now, especially considering that White House officials repeatedly claimed to be dealing with the situation 24 hours a day from February. And on the official issue.
It is well known that when the Abbott Michigan issue was fully published in February, the government began tracking national stock rates and sales data for powdered milk. Sources have told CNN.
This is what they saw in those trends: in March, the availability of formulas on store shelves dropped significantly, and many It suggests that the item was out of stock. However, it appeared to be stable in April. Authorities increased production of powdered milk and allowed powdered milk families to purchase through the Federal Nutrition Program. The first actions taken by the FDA and USDA to relax the rules have begun to help.
But in May, inventory rates began to fall again.
Meanwhile The sales data that the government was tracking told another story. The purchase of powdered milk was about the same as the level from the previous year to March and April. Officials said during that few months that certain products The family interpreted that they were able to get the prescriptions they needed, even if they were gone from the store shelves, but these products could sell out quickly and the store long before they were struck. Didn't sit on the shelves.
But that also began to change in May, and the administration saw a noticeable rise in sales levels.
"First of May When I saw the sudden rise in buying patterns in the last two weeks, I started to realize that something new was happening in the market, and everything had a sudden demand shock. "
Officials said the confluence of reduced shelf availability and increased sales was a bright red flag. The supply chain at that moment.
That new concern in May may help explain why Biden said he wasn't informed about the seriousness of the formula shortage until sometime "after April." .. White House spokesman Karine Jean-Pierre distracted many questions from reporters about why they weren't previously informed and which of his advisers eventually filled him out.
Insufficient institutions for food prediction
"The FDA was an important partner in the president's goal of accelerating the availability of safe infant formula, but ultimately it's up to Abbott to end this shortage. "A White House official said. Statement to CNN.
Part of the reason is the lack of resources and data provided to the FDA department to track food, a former FDA official told CNN.
The FDA monitors food and medicine, but former officials say food monitoring is less sophisticated than the drug side, and authorities predict potential food shortages. He said he wasn't ready. The important thing is that infant formula is a food product.
For example, if a drug manufacturing plant could be closed, the FDA has the authority to understand the implications of the supply chain and, as a result, related to access to specific drugs. There may be problems that may occur. Former officials said if the facility was closed.
The FDA has requested Congress to expand these authorities. This dates back to 2020, when the FDA sought to better understand supply chain issues.
FDA Commissioner Dr. Robert Caliph publicly acknowledged these issues in a panel hearing in the Senate in May.
"Currently, we have little authority other than reviewing when a product comes in," Caliph told lawmakers.
"Currently, companies do not need to be notified in the event of an imminent shortage. If samples in the facility find contaminants that have not yet been shipped, they need to allow us. There is no requirement that there be. I know, "The Caliph pointed out that Abbott had detected Cronobacter in a sample of that prescription, but did not tell the authorities.
The FDA said. In a statement to CNN, the FDA argued that it continued to provide relevant information to its federal partners throughout the year.
"The FDA is working to address supply chain issues for infant formulas both before and after the recall, and has raised concerns and efforts to mitigate these with federal partners such as USDA, HHS and the White House. I keep informing you. I've been trying all the time. "
"These interactions relate to pandemic-related infant formula supply chain issues and the widespread market impact of facility recalls and shutdowns from the largest formula milk providers in the United States. It included expressing concerns clearly, "a spokeswoman 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 stopped producing formulas again after a violent storm caused floods in the city, including inside the factory.
"Sorry," Jean-Pierre said when asked about his recent setbacks. "What we can do is increase production, increase supply, and ensure that American families only have access to safe prescriptions. That is our focus. That is what we control. .. "