Sudden shortage of Subject A infant formula in Washington

The company’s infant plant in Sturgis, Michigan, which used to be a major part of the entire U.S. infant formula supply, has been closed since mid-February, following a a Food and Drug Administration investigation after four infants who consumed formula from the factory were shut down. hospitalized with a rare bacterial infection, Cronobacter sakazakii. Two died. Since then, the agency and the company have been in talks on how to reopen the factory, which has been cited for serious food safety lapses. The agency also found five strains of Cronobacter in the plant. A whistleblower had raised concerns about the plant with senior FDA officials in October, as POLITICO previously reported.

The company has maintained that its products are not the likely source of the infections and has worked to address any food safety issues reported by the FDA.

Although the infant formula recall has received the most attention, the shortage of specialty formula is an increasingly urgent and life-threatening situation, as POLITICO recently reported, as the Sturgis plant manufactured the share the lion’s share of these preparations that are sold in the United States.

Abbott Nutrition has also begun marketing limited quantities of specialty formulas, which are the only nutrition for thousands of infants, children and adults with rare metabolic, gastrointestinal and allergic diseases (the products have been manufactured for the recall period).

Business Consolidation: Democrats, for their part, are now raising red flags about market consolidation and the role that may have played in the shortage. Sense. Cory Booker (DN.J.), Amy Klobuchar (D-Minn.) and Tammy Duckworth (D-Ill.) led a letter to Agriculture Secretary Tom Vilsack on Friday urging the USDA to use its powers to make the market more competitive. The request comes a day after Duckworth wrote to the FTC request a formal sector study.

In 2018, four companies — Abbott Nutrition, Mead Johnson, Nestlé and Perrigo — were estimated to control 89% of the U.S. market, an “alarming level of corporate concentration,” according to lawmakers. Abbott Nutrition, the company that makes Similac, controls about 40% of the infant formula market, they said.

Republican Fire: Republicans have been relentless in recent days in trying to shift the blame onto Biden.

“Bare Shelves Biden needs to STOP passing the buck and address his formula shortage,” tweeted House Republican Conference Speaker Elise Stefanik. “American families are suffering once again because of him..”

The shortage issue fits into the larger political debate over rising prices in the United States, as the right tries to push Biden’s approval numbers even lower ahead of the midterms.

“Record inflation, skyrocketing gas prices and a shortage of baby formula,” the senator tweeted. Marsha Blackburn (R-Tenn.) this week. “American families deserve better.”

Former President Donald Trump weighed in on Friday, saying in a statement that it was “unthinkable that in 2022 American families could not get infant formula for their children,” and calling it “a mark of shame. forever on the Democratic Party. .”

House Democrats: house tenant Nancy Pelosiin a letter to congressional democrats, said the shortage was “unacceptable and tragic”. Unlike other Democrats, Pelosi made no effort in the letter to credit the Biden administration for continuing to work with the FDA while taking other steps to address the shortage, but said Democrats of the House would take several steps to try to help solve the problem.

Pelosi said Rep. Rosa DeLauro (D-Conn.), who chairs the appropriations committee, plans to introduce an emergency supplementary spending bill in the House “to immediately address the shortage of infant formula.” DeLauro and other committee leaders are planning congressional hearings on the issue. Democrats will also work on legislation to “grant emergency authority to the WIC program to deal with supply chain disruptions and recalls,” Pelosi said, referring to the federal nutrition program for women, men and women. low-income infants and children.

White House Steps: Pelosi’s letter came shortly after the White House announced on Friday that Abbott had agreed to extend WIC discounts for all of their contracted products through the end of August, following a letter requesting the change. of Agriculture Secretary Tom Vilsack.

Abbott previously resisted extending the deadline, according to people familiar with the matter. Flexibility essentially means that the company pays for WIC families to get the competitor’s formula – huge financial and brand success.

A spokesperson for Abbott confirmed the deal to POLITICO. The spokesperson also added that the company has prioritized infant formula production at its plant in Columbus, Ohio, and has air-shipped millions of boxes of infant formula powder to the United States. United from its FDA registered facility in Cootehill, Ireland, since the Michigan factory closed.

Biden, asked by reporters on Friday afternoon whether the administration should have acted more quickly, replied, “If we had been better mind readers, I guess we could have. But we acted as quickly as the problem appeared to us.

“We need to move cautiously and quickly,” Biden added. “Because we have to make sure that what we get is actually a top-notch product. This is why the FDA has to go through the process.

White House press secretary Jen Psaki said at a Friday press briefing that WIC rebates and other measures to increase flexibility were the “main issue” formula makers have raised. with the president in a meeting on Thursday.

PSAKI also said that the Department of Health and Human Services has launched a new webpage, hhs.gov/formula, where parents can go for formula and other advice amid shortages. She said the administration would announce additional measures in the coming days.

FDA Import Plans: FDA chief Robert Califf said Friday that the agency will announce plans next week to import more infant formula from overseas. Califf said the FDA “would describe[e] how overseas manufacturers and suppliers can import their products into the United States, as well as additional flexibilities for domestic manufacturers and suppliers.

Jessica C. Bell