WASHINGTON – President Joe Biden swatted away suggestions in May that his administration should have responded sooner to a baby formula shortage that left store shelves bare and incited panic among parents.
“If we’d been mind readers, I guess we could have,” Biden said at the White House. “But we moved as quickly as the problem became apparent to us.”
But the problem was apparent months ago, long before the White House appeared to kick into high gear to respond to the crisis last month, invoking war-time powers to increase production, lifting regulations on formula transport, and convening retailers and manufacturers to discuss solutions.
The Food and Drug Administration – part of Biden’s administration – knew a major producer of baby formula shut down a contaminated plant and recalled its products in February, depleting an already strained supply and sending families across the nation searching for limited nourishment for their babies.
“You don’t have to be a mind reader” to recognize the problem, said Peter Pitts, the FDA's former associate commissioner. “You just have to be a reader.”
Biden said Wednesday he wasn't alerted that the nation faced a looming shortage of baby formula until April, even though executives of baby formula manufacturers said they sounded the alarm to retailers two months earlier.
"We knew from the very beginning that this would be a very serious event," said Robert Cleveland, senior vice president at Reckitt, which produces baby formula.
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Pitts and other analysts said the administration could have acted much earlier to ramp up production, institute limits on hoarding and import formula from overseas.
The national shortage, triggered by the safety-related closure of Abbott Nutrition'sformula-making plant in Sturgis, Michigan, and a recall of formula produced at that factory, was compounded by a lack of communication.
The White House has defended the administration’s response, contending that while more needs to be done, it has worked nonstop for months to alleviate supply issues.
“We have to move with caution as well as speed because we got to make sure what we’re getting is, in fact, first-rate product,” Biden said last month.
Still, the shortage has infuriated lawmakers, who are demanding to know not only how it happened but how it can be prevented from happening again.
"Babies and children are suffering," Rep. Diana DeGette, D-Colo., said last week during a hearing on the crisis. The shortage was “unacceptable – and worse – it was totally preventable,” she said.
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At the same hearing, Rep. Cathy McMorris Rodgers, R-Wash., blamed the shortage on the FDA and the Biden administration's failure to act early enough. Throughout the COVID-19 pandemic, she noted, the FDA had a data and analysis tool to monitor supply changes.
"The FDA didn't have to read minds,” Rodgers said. “They just had to read their own data."
Early warning signs
Infant formula started to disappear from the nation’s shelves last summer, partly because of supply chain disruptions tied to the COVID-19 pandemic.
But the shortage grew critical after the closure of the Sturgis factory.
The shutdown came during an FDA investigation of bacteria infections found in four infants who got sick after consuming powdered formula manufactured at the plant. Two of the infants died.
Abbott announced a recall of three powdered formulas, halted production and closed the plant while the FDA investigated. The agency found bacterial strains inside the plant, but bacterial strains found at the facility didn't match the two available samples from the babies. However, the bacteria they found was troubling enough to warrant the shuttering of the facility in February.
A whistleblower had sent a complaint to the FDA four months earlier alleging a litany of problems at the plant, including lax sanitation practices, failure to properly test for bacteria in infant formula and falsification of records.
The former employee reported “active efforts were undertaken and even celebrated” at the factory to keep FDA inspectors in 2019 from learning about events related to “the discovery of micros in infant formula at the Sturgis site,” according to a copy of the complaint.
The Sturgis plant produces about a quarter of the baby formula sold in the U.S., according to Sudip Saha, chief operating officer of Future Market Insights, a market research firm. Abbott overall supplies 46.2% of the U.S. market, according to Saha.
FDA Commissioner Robert Califf said at last week's hearing that the timelines in interviewing the whistleblower and getting into the facility for inspections were "too slow.” The complaint was submitted to the FDA on Oct. 20, but the agency did not interview the author until late December and inspect the plant until Jan. 31.
"Some decisions, in retrospect, could have been more optimal,” Califf said.
Frank Yiannas, the FDA’s deputy commissioner for food policy and response, told lawmakers at the hearing that he didn’t learn about the complaint until four months after it was filed. Yannis said he never received the report until around Feb. 10.
"I'm not sure why the record wasn't shared with me and how it didn't get escalated,” he said.
Abbott said last week it expects to restart production at the Michigan facility the first week in June and have its formula back on shelves six to eight weeks after that.
"We know we let you down, and we're going to do everything we can to re-earn your trust," Abbott Senior Vice President Christopher Calamari said.
Addressing reporters after the 50-minute meeting, Biden repeated what he's said before. "I don't think anyone anticipated the impact of the shutdown of Abbott facility," he said. But his remarks came just minutes after manufacturers said they anticipated a shortage.
“They did, but I didn't," Biden said. “We did everything in our power from that point on. That's all I can tell you right now. And we're going to continue to do it together.”
'No leadership, no governance'
Millions of parents rely on infant formula in the United States to meet the nutritional needs of babies up to six months old.
When the Abbott plant was closed, FDA officials said they began tracking in-stock data for baby formula for the first time, and they said they tried to coordinate with other formula manufacturers and government agencies to increase supply and manage supply-chain impacts.
But by early May, about 43% of popular formula brands were sold out across the country – up from 30% a few weeks earlier, according to Datasembly, which tracks supplies at thousands of stores. Retailers including Target and CVS had instituted limits on the amounts customers could buy at a time.
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Rep. Rosa DeLauro, D-Conn., said in an interview with USA TODAY last week Wednesday that, given Abbott Nutrition’s market share, the FDA should have better managed the shutdown and recall impacts to reduce the shortages.
“You're sitting down and saying, OK, we're going to recall – we’re going to pressure Abbott into recalling their product ... OK, the next question is how do we make up for it?” said DeLauro, who chairs the House Appropriations Committee.
“Why didn't Abbott have a contingency plan? Why didn't the FDA have a contingency plan? It's really mind-boggling to think that you would not say ...What do we do? That is going to be a shortfall. How are we going to, where are we going to direct people? It really is a bad actor in the manufacturing and just no leadership, no governance on food safety at the Food and Drug Administration.”
She said while the FDA dragged its feet, she believes theWhite House acted quickly to alleviate the shortages in recent weeks.
Biden's revelation he did not know about the shortage until April offers the clearest timeline yet of when the president knew about the crisis. The White House did not respond to questions last weekabout when the president was alerted to problems at the Sturgis plant and the looming formula shortage. Last month, White House press secretary Jen Psaki also dodged questions about when the president was first briefed on the shortage.
“What I will note,” she said, “is that there has been work ongoing on this for months.”
Generally, the FDA would be responsible for informing the Department of Health and Human Services about issues like the problems found at the Sturgis plant and the possible consequences of shutting down that facility, said Pitts, who served as the agency’s associate commissioner under President George W. Bush.
“When something like this happens, it is run up the chain very fast to the secretary,” said Pitts, a visiting professor at the University of Paris School of Medicine. “Clearly, the FDA recognized this was a big deal.”
Pitts said HHS Secretary Xavier Becerra was likely informed by the FDA of the formula troubles shortly after the plant shutdown. But it’s unclear whether Becerra didn’t tell Biden or White House officials, whether those officials didn’t inform Biden or whether Biden was briefed but failed to act.
“My strong suspicion is the White House didn't know about it until the public knew about it,” William Marler, a food safety lawyer and advocate,said. But he said, "it strikes me that somebody (at the White House) should have been on it.”
Becerra’s office did not respond to a request for comment.
Health policy expert Joe Antos said there appeared to be a serious lack of communication between the FDA, Becerra’s office and the White House.
“When they decided to shut down the largest formula plant in the country in February, it should have been obvious that there could be a problem,” said Antos, a senior fellow at the American Enterprise Institute, a center-right think tank based in Washington.
“I'm guessing that probably the mid-level folks at FDA realized that,” Antos said. “But from their position in the bureaucracy to anywhere higher is quite a lift to get anybody to pay attention. I think that’s part of the problem.”
With the administration facing mounting criticism over the formula shortage, Biden invoked the Defense Production Act on May 18 to speed up production of formula and authorized flights to import an emergency supply from overseas.
Antos said importing baby formula from overseas was a smart move, but one that should have been done earlier. To avert the baby formula shortage, the FDA should have moved more quickly to ease nutrition and labeling regulatory requirements that prohibit the U.S. from importing most formula produced in Europe, Antos said.
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“There are a lot of babies who have somehow survived baby formula in Europe,” he said. “I’m pretty sure that they’re similar to the babies we grow here.”
Antos and Pitts both dismissed Biden’s decision to invoke the Defense Production Act to speed up formula production as a political move that won’t ease the shortage. The crisis was caused by safety concerns and supply chain issues – not a lack of ingredients used to manufacture formula.
Invoking the Defense Production Act is simply hastening the manufacturing of ingredients such as corn syrup and rice starch, commodities that are available in abundance, Pitts said.
“It’s not going to make a whit of difference,” he said. “It’s political theater.”
Contributing: Candy Woodall and The Associated Press
This article originally appeared on USA TODAY: Biden's baby formula response could have been better, analysts say