U.S. Capitol | Susan J. Demas
WASHINGTON — Both the Biden administration and Congress moved Wednesday to try to relieve a national infant formula shortage, as the White House invoked the Defense Production Act and the U.S. House approved $28 million for the Food and Drug Administration.
President Joe Biden said he would use the law to address the formula shortage, requiring suppliers to fill orders from formula manufacturers before other customers.
Biden also directed Health and Human Services Secretary Xavier Becerra and Agriculture Secretary Tom Vilsack to use Defense Department planes to more quickly import formula from overseas that meets U.S. health and safety standards.
“Imports of baby formula will serve as a bridge to this ramped up production, therefore, I am requesting you take all appropriate measures available to get additional safe formula into the country immediately,” Biden wrote to the secretaries.
Meanwhile, the House voted mostly along party lines late Wednesday to approve the FDA funding, but Republicans overwhelmingly opposed it, saying that it would provide a blank check to the FDA and that it doesn’t take steps to actually get infant formula back on store shelves quickly.
The measure is unlikely to get past the U.S. Senate’s legislative filibuster without GOP backing, meaning lawmakers in that chamber will either have to amend the bill, or start from scratch on their own legislation.
The final House vote was 231-192. All Democrats and 12 Republicans voted in favor.
“The emergency funds allocated by this bill will help safely expedite the inspection of the country’s infant formula supply and quickly get it back on the shelves of stores across the country,” said U.S. Rep. Sanford Bishop Jr., a Georgia Democrat who chairs the House spending panel that oversees FDA funding.
Bishop said Congress should also investigate how the problem occurred in the first place.
But Maryland’s Andy Harris, the acting top Republican on that spending panel, said the Biden administration should have gotten ahead of the problem when shortages started last fall. He said Democrats’ approach amounted to “throwing money at the problem” after it became a crisis.
“This is not a money problem,” he said. “This is a leadership problem.”
House Energy and Commerce Chairman Frank Pallone, a New Jersey Democrat, responded that when his committee has tried to create a funding mechanism for food safety, Republicans have blocked it.
“If that money had been in place, we would have had the inspectors,” he said. “We would have had the ability, in my opinion, to do a lot more on the issue of food safety.”
The bill, which U.S. House Democrats released Tuesday, would give the FDA an additional $28 million to address the current infant formula shortage, prevent future shortages and stop fraudulent products from entering the country.
About half the formula sold nationwide is bought by families using benefits under the Special Supplemental Nutrition Program for Women, Infants, and Children, which is administered by the USDA. In his own press release, Vilsack said he understood the shortage was “causing stress and anxiety for many families” and pledged to undertake the actions Biden had called for under the Defense Production Act, which gives emergency authorities to the chief executive.
“As the President directed, the Department of Agriculture will immediately begin coordinating with the Department of Defense and expand its coordination with our Health and Human Services counterparts to get safe formula on store shelves as quickly as possible,” he said.
The supplemental funding bill the House passed Wednesday was meant to work in tandem with Biden’s actions, the bill’s sponsor, Connecticut Democrat Rosa DeLauro, said during floor debate.
The current shortage began in mid-February, when Abbott Laboratories had to close its Sturgis, Michigan, plant after four babies became sick and at least two died. In the four months since, other plants have struggled to keep up with demand as store shelves have increasingly emptied.
That Abbott manufacturing facility will be allowed to reopen soon under a consent decree with the U.S. Justice Department that will require the company to take several steps to address safety at the facility.
The plant’s managers will need to hire “outside expert assistance” to ensure they comply with federal law and good manufacturing practice regulations.
The Justice Department also filed a complaint in federal court in the Western District of Michigan as part of the agreement that alleges Abbott “manufactured powdered infant formula under conditions and using practices that failed to comply with regulations designed to ensure the quality and safety of infant formula, including protection against the risk of contamination from bacteria such as Cronobacter sakazakii.”
Abbott said in a statement that it would need about two weeks to restart the facility. After that it would take six to eight weeks before products would begin appearing on store shelves.
The company plans to begin production of Alimentum, EleCare and metabolic formulas before restarting production of Similac and other formulas.
Abbott President of U.S. and Canada Nutrition and Senior Vice President Christopher J. Calamari will testify about the shortage in front of the U.S. House Energy and Commerce Committee on May 25.
Pallone and Oversight and Investigations Subcommittee Chair Diana DeGette, a Colorado Democrat, said when announcing the hearing that “it is unconscionable that families are struggling to find safe and affordable infant formula.”
FDA Commissioner Robert M. Califf is scheduled to testify at that hearing as well as one Thursday in front of the U.S. House panel that drafted the $28 million bill and controls the agency’s funding levels.
The chair of that panel, DeLauro, released a whistleblower report from an employee at the factory that alleges Abbott officials falsified records, released untested infant formula and hid information during a 2019 FDA audit.
The Connecticut Democrat said at the time that she was concerned the FDA “reacted far too slowly to this report.”
“The report was submitted to the FDA on October 20, 2021. The FDA did not interview the whistleblower until late December 2021. According to news reports, FDA did not inspect the plant in person until January 31, 2022, and the recall was not issued until February 17, 2022.”
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