Big Questions Remain About White House Plan to Speed Formula to Shelves

Big Questions Remain About White House Plan to Speed Formula to Shelves

WASHINGTON — Biden administration officials on Thursday said that a baby formula shortage would continue at least into next month, leaving desperate parents continuing to search for ways to feed their infants even as President Biden and his aides defended their efforts to help restock empty shelves.

Dr. Robert Califf, the head of the Food and Drug Administration, told angry lawmakers on Capitol Hill that some efforts — including relaxed guidelines for imports and ramped-up domestic manufacturing — could increase supplies within days. But he said availability of baby formula in stores would not return to normal for weeks.

At the same time, administration officials struggled to explain how Mr. Biden’s decision to invoke a Cold War-era statute will help alleviate the shortage of baby formula that has exasperated families across the nation and led to heartbreaking reports of infants sent to the hospital for lack of food.

On Wednesday, Mr. Biden authorized use of the Defense Production Act in an effort to ensure formula manufacturers had access to the ingredients and materials they needed to ramp up production. Shortages developed after Abbott Laboratories, which controls 48 percent of the baby formula market, voluntarily recalled some of its most popular products in February and shuttered a plant in Sturgis, Mich., over concerns about possible contamination.

But a senior administration official, who spoke to reporters Thursday on the condition of anonymity, declined to say whether any formula companies reported having trouble getting ingredients or materials in a timely manner.

In response to numerous questions about the potential impact of the president’s decision, the official repeatedly said the administration was “having active and ongoing conversations with the companies” but declined to say what the companies had requested or even whether the firms had identified problems that required government assistance.

The official did not provide information about how much faster the administration believed formula would reach consumers with the invocation of the Defense Production Act. And the official declined to answer when asked why Mr. Biden did not authorize the use of the law weeks ago, when the shortages became much more pronounced.

In a statement, Abbott Laboratories said the act “can be an effective tool to prioritize raw materials and ensure supply of specialized components.”

“We’re already express air-freighting infant formula from our F.D.A.-registered facility in Ireland and welcome any support that these added measures can provide in cutting red tape, increasing volume of imports and speeding up transport time from overseas to the U.S.,” the company said.

The F.D.A. and the White House have raced in recent days to respond to the public outcry over bare grocery store shelves and concerns that desperate parents were rationing their stock or resorting to possibly risky homemade mixtures to feed their infants.

In a video posted to Twitter on Wednesday, Mr. Biden said, “I know parents all across the country are worried about finding enough infant formula to feed their babies. As a parent and as a grandparent, I know just how stressful that is.”

Tinglong Dai, a professor at the Johns Hopkins Carey Business School, said the response reminded him of the Biden administration’s approach to masks and tests during the pandemic.

“They ignored a crisis that was coming,” he said. “They had three months’ time to resolve this potential crisis, but they didn’t do much.”

Mr. Dai said the administration’s recent efforts would help but that the effect would be limited because the industry’s problems had more to do with production schedules and labor shortages.

The latest shortage stems from the shutdown in February of the Sturgis plant, where the F.D.A. had discovered evidence of a potentially deadly bacteria called cronobacter sakazakii. The company launched a major recall that has resulted in gaping holes in formula availability. Federal agencies have been investigating several cases of illness in babies beginning last fall, including two deaths, though no definitive link to the formula has been established.

On Monday, the F.D.A. announced it would relax strict guidelines for imports of baby formula from other countries in an effort to restock shelves in the United States.

On Thursday evening, the White House announced that the Defense Department would help transport about 1.5 million 8-ounce bottles of formula from Zurich to Plainfield, Ind., for distribution in the United States. The formulas — Alfamino Infant, Alfamino Junior, and Gerber Good Start Extensive HA — are all for children who are allergic to cow’s milk protein, according to a White House statement.

The F.D.A.’s delayed recognition of the crisis-level shortage and its failure to tackle problems in the troubled formula plant prompted heated questioning of Dr. Califf during an F.D.A. budget hearing on Thursday.

Representative Rosa DeLauro, a Democrat of Connecticut and chairwoman of the House Appropriations Committee, pressed him to account for what she characterized as a sluggish response to clear problems at Abbott’s plant. She said a September inspection turned up evidence of the bacteria in finished formula but that the agency did not shut the plant down until February.

“It all begs the question of: Why did the F.D.A. not spring into action?” Ms. DeLauro asked. “Why did it take four months to pull this formula off the shelf? How many more illnesses and deaths were caused due to the F.D.A.’s slow response?”

Dr. Califf acknowledged to lawmakers that the agency was conducting an internal review to see if any errors were made. But neither he nor other administration officials could offer even rough estimates of how many tons of formula were set to be produced, where it would come from, or when it might make its way to consumers.

As baby formula supply began to fall in recent months, sales began to surge, most likely reflecting a wave of panic buying.

The shortage has spiraled into a health crisis for the administration and Congress.

The Senate on Thursday unanimously approved a measure that would expand what kind of formula can be purchased using benefits from the federal food aid program for women and babies. About half the formula sold in the United States is purchased with benefits from the Special Supplemental Nutrition Program for Women, Infants and Children, known as WIC.

“It’s rare that we have unanimity in the Senate on important measures — and I wish we had more — but this is one of these important issues,” said Senator Chuck Schumer of New York, the majority leader.

Without formally taking a vote, the Senate sent it to Mr. Biden for his signature a day after the House overwhelmingly passed the legislation. The fate of a separate $28 million emergency aid package for the F.D.A. is more tenuous amid Republican opposition.

The Defense Production Act was created to give the government the power to ensure the flow of weapons during wartime.

During the coronavirus pandemic, President Donald J. Trump invoked it as a way of accelerating the production of personal protective gear for hospital workers and the manufacture of vaccines and other drugs to fight Covid-19. Earlier this year, Mr. Biden invoked the law to increase domestic production of critical minerals and metals needed for technologies like electric vehicles.

But analysts said the Defense Production Act may be an ill-suited tool, as the problems in the formula market did not originate with supply chain or transportation issues — a reality that Transportation Secretary Pete Buttigieg acknowledged in an interview over the weekend.

“A shortage of ingredients is not what led to the shutdown of the facility,” Mr. Buttigieg, himself the father of two young children, said on CBS’s “Face the Nation” on Sunday.

While formula makers have faced rising costs for their inputs, and a dearth of truckers and warehouse space has at times made it difficult for retailers to promptly restock their shelves, formula shortages stem far more from Abbott’s production problems — and safety issues and market concentration of the formula industry more broadly, analysts said.

Formula is produced in just a few huge plants in the United States, making the industry efficient but also vulnerable to a shutdown. The shuttered Abbott plant in Michigan is also responsible for a significant share of specialized formula for infants with allergies or other health conditions, for which there may be no close substitutes.

U.S. rules also make it difficult to import foreign formula, even from Europe. The U.S. levies a 17.5 percent tariff on most foreign formula, and companies that want to import products face onerous restrictions.

Removing red tape to allow foreign products into the country could help alleviate some pressures. But even then, it will be weeks before foreign formula can make its way to U.S. shelves and Abbott can restart production at its Sturgis plant.

Several congressional Democrats on Wednesday praised the president for taking action, saying the administration should do everything possible to resolve the shortages. Some Republicans, however, criticized the administration for misusing the act.

“It seems the administration has no use for the word ‘defense’ in Defense Production Act,” Senator Patrick J. Toomey, Republican of Pennsylvania, said in a statement. He accused Mr. Biden of “misusing the D.P.A. statute every time there’s a temporary product shortage.”

Emily Cochrane contributed reporting.

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