White House officials initially thought the situation was under control when a major infant formula plant shut down and issued a recall in February.
Part of the reason for that, Biden officials now privately acknowledge, was that they did not have complete data on retail stock rates for infant formula, which kept them in the dark about the true scope of the emerging shortages. The rush by the country’s leading formula companies to push all their reserve stocks into the market may also have distorted the data, giving the White House a false sense of security.
At the time, the issue was being tracked by small teams of staff within the White House’s Domestic Policy Council and National Economic Council, who had been monitoring general supply chain concerns regarding formula even before the recall, according to three White House officials not authorized to speak publicly on the matter. They concluded that the recall by Abbott Nutrition did not warrant involvement by the president and top staff, who were consumed by the early stages of the war in Ukraine — launched a week after Abbott’s plant in Sturgis, Mich. shut down — and renewed concerns about the spread of Covid-19, as a new Omicron variant ripped across Europe.
“There were a million crises going on,” said one White House official on the Domestic Policy Council, who was not involved in the immediate response and who didn’t hear about the infant formula issue during team meetings with Domestic Policy Council head Susan Rice or other senior team members for weeks after the recall. “That doesn’t mean that this wasn’t also a crisis, it just wasn’t elevated to a top level crisis.”
That didn’t happen until early May, according to the three White House officials — only after desperate parents began flooding social media with images of empty store shelves and everyone from Donald Trump Jr. to potential 2024 presidential candidate Sen. Tom Cotton (R-Ark.) began tweeting about the formula shortages. Two officials from the Food and Drug Administration who were also not authorized to speak publicly about the matter confirm senior White House involvement on the infant formula response was limited until May.
The lack of clarity about infant formula stocks and failure to communicate the risks to the highest levels at the White House help explain how a serious situation rose to a crisis before the Biden administration mounted a full-blown response. The delay has handed Republicans a ready-made talking point, just months before fall midterm elections that are expected to hinge on President Joe Biden’s management of the economy.
The White House maintains that it took immediate action when data the administration was tracking showed infant formula supplies dropping in April. And it notes that sales and production of infant formula have increased this year, despite the shortages.
White House officials also point out the Biden administration has been working diligently with the country’s four major formula companies since February to contain the fallout from the closure of the Abbott plant, which at the time was producing one-fifth of the nation’s formula supply, according to rough estimates. FDA reached out to the three other major formula companies to help ramp up production shortly after the Abbott recall, while the Agriculture Department worked to ease restrictions on the federal nutrition program known as WIC, to make it easier for low-income parents to use their benefits to buy formula. Those processes unfolded over a span of weeks.
However, the president, himself, has admitted he wasn’t aware of the seriousness of the shortages until April. As POLITICO reported, Biden recently exploded at aides for being kept out of the loop for months.
And the White House didn’t move to invoke the Defense Production Act to fast-track formula production and organize flights of foreign formula from Europe and Australia until May 18. The Agriculture Department and FDA loosened regulations on the domestic formula market to make it easier to access formula around the same time. Officials acknowledge it will still take much of the summer, or longer, to fully restore supplies.
Biden officials have privately complained the larger administration response was also hobbled by FDA’s delayed response to early warnings about conditions at the Michigan Abbott plant. Those concerns were ultimately borne out when the FDA inspected the plant over the winter and found five different strains of Cronobacter sakazakii, a bacteria that can be deadly if consumed by newborns. FDA was first alerted to a case of Cronobacter infection linked to the formula made in the plant in September 2021, and received a 34-page whistleblower report alleging serious health violations in October, but did not go back to inspect the plant until the end of January.
Officials have also questioned FDA’s lack of coordination with other parts of the Biden administration. That includes USDA, which oversees the WIC program, which purchases half of all infant formula in the U.S. Agriculture Secretary Tom Vilsack told POLITICO that FDA didn’t alert his department about potential infant formula supply problems until the “first or second week of February.” FDA says it told USDA’s WIC program a week before the Feb. 17 recall.
But the White House has declined to say when the FDA first notified it about the problems at the Abbott plant and possible shortages a closure would trigger. Asked by POLITICO, FDA Commissioner Dr. Robert Califf also declined to specify a time frame. FDA and the White House have declined to provide any records of communications between the White House and FDA about the early response.
An FDA spokesperson says the agency has been working closely with the White House, USDA and the Department of Health and Human Services on the infant formula response before and after the recall. “These interactions included clearly communicating our concerns about infant formula supply chain issues associated with the pandemic and the wide-reaching impact the recall and shutdown of a facility from the largest U.S. formula provider would have on the market,” the spokesperson said.
“President Biden took urgent, emergency action as more generalized shortages emerged in the infant formula market,” said a White House official. “By invoking the Defense Production Act, landing 10 million bottles and counting through Operation Fly Formula, and working closely with manufacturers 24/7 to identify areas we can expedite getting formula to American families, the President has led with urgency and solutions needed to deliver for American families due to Abbott’s recall.”
“The FDA has been a vital partner in the President’s goal of accelerating the availability of safe infant formula, but ultimately, it is going to be up to Abbott to end this shortage,” the White House official added.
Biden, however, seemed to acknowledge the disconnect between the policy response and the reality on the ground last week in a meeting with top formula company officials. At one point, the president asked the formula executives if they initially recognized how big a crisis the Abbott recall and plant closure would create. “We knew from the very beginning this would be a very serious event,” replied Robert Cleveland, a top executive at Mead Johnson, which is owned by Reckitt and was the second largest infant formula manufacturer in the U.S. before the recall.
“They did. I didn’t," Biden later told reporters observing the meeting.
In an interview after his visit to the White House, Cleveland explained, “We live and breathe this every day. This is all that we do. So it's natural that we would expect to ... see the consequences of it faster than anybody else.”
Cleveland also noted that his company, in coordination with FDA, pushed all of its reserve supplies into the market and urged its retailers to do the same. That meant a surge of infant formula products hit the shelves shortly after the Feb. 17 Abbott recall, cushioning the drop from the loss of Abbott products.
“So [the formula shortage] probably wasn't as visibly bad in the very beginning as it is now,” Cleveland said.
The White House and FDA have been trying to track the amount of infant formula on store shelves using data supplied by some formula companies, retailers and IRI, a market research firm, but they do not have a full picture.
According to the infant formula data compiled and released by the White House this week, current national in-stock rates are around 74 percent. Before the recall, according to the same data, in-stock rates were around 90 percent, although supply chain constraints had been disrupting infant formula supplies throughout the pandemic.
The national stock rates also don’t show the regional drops in availability of formula, which have been severe in some areas, according to the dozens of parents and caregivers in various parts of the country POLITICO has spoken with since February. Data from other firms, meanwhile, show more significant shortages since February compared to information released by the White House.
The White House says it took immediate action after national in-stock rates ticked down during the month of April, hitting 80 percent, according to the IRI data shared by the White House. But internal indecision gripped the White House when the formula shortages exploded into a political crisis in early May. Then-press secretary Jen Psaki initially appeared to publicly rule out using the Defense Production Act, telling reporters it wouldn’t work to speed up infant formula production. A White House official says the economic team was debating how to use the measure and came to the conclusion that formula is too specific a product to try and manufacture in other facilities, as the law would enable.
Meanwhile, incensed Democrats were flooding senior White House officials with calls and letters, pushing Biden to do more as Republicans hammered them for their party’s inaction. Rep. Abigail Spanberger, a vulnerable Virginia Democrat, pressed White House chief of staff Ron Klain to loosen import restrictions and invoke the DPA. Amid mounting pressure, FDA on May 16 announced it would temporarily lift some import rules. Two days later, Biden invoked the DPA, after the economic team settled on using the measure to direct suppliers to give formula manufacturers priority in ordering raw materials as a means to speed up production.
The White House also quickly marshaled a media campaign designed to show Biden was in command of the issue, deploying Agriculture Secretary Tom Vilsack, a long-time Biden ally, on cable TV and eventually to the tarmac of Indianapolis’ airport, where he greeted the administration’s first flight of formula from abroad.
It was a public rapprochement for Vilsack, just a few weeks after the White House and congressional Democrats triggered the Agriculture secretary's ire by agreeing to pay for a Covid-19 emergency package by clawing back pandemic funds from his department. Vilsack was so angry about the move that he complained on a call with USDA staff that no one at the White House, other than the president, understands what his agency does, according to two people on the call. (A USDA spokesperson says Vilsack “categorically denies the suggestion that there has been any separation between USDA and the White House.”)
On Saturday, the Abbott plant in Sturgis reopened as part of a consent decree with the administration, with a focus on producing Elecare, a specialty formula designed for infants and other people with certain digestive issues. The formula shortages have been especially dangerous for parents of infants, children and adults who have medical conditions that require them to drink formula as their only source of nutrition. The shuttered Abbott plant in Michigan was a key supplier of such specialty formulas, some of which the White House has been working to fly in from abroad.
FDA officials have said they’ve paid special attention to the availability of prescription formulas for infants and adults with rare metabolic conditions. But supplies of Abbott’s prescription formula, packaged before Feb. 17 and supposedly exempt from the recall, sat in a warehouse for more than two months before Abbott told health care providers they could start requesting shipments of that formula on a case-by-case basis. FDA and Abbott officials have blamed each other for the delay.
Relations between Biden officials and Abbott have been tense, in general, amid the formula fall-out, according to three people familiar with their communications. Abbott tends to support politically conservative politicians and policies — in contrast to the more left-leaning Reckitt, with whom White House officials have dramatically better relations, the people said.
According to Karen Dolins, whose 28-year-old-daughter relies on a special prescription of Abbott metabolic formula, Abbott still has not told families when supplies of the formula will be available from new production since the Sturgis plant reopened.
Dolins said it was clear when it came to the White House’s response: “Whoever was giving them information was either not recognizing the urgency or not relaying the urgency.”
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By: Meredith Lee
Title: Not 'a top level crisis': What the White House initially missed about the infant formula shortage
Sourced From: www.politico.com/news/2022/06/09/white-house-misunderstanding-of-baby-formula-supply-deepened-shortage-crisis-00038235
Published Date: Thu, 09 Jun 2022 03:30:00 EST
