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Pelosi says indictment could be filed for lack of formula

House Speaker Nancy Pelosi said indictments could be filed over infant formula shortages, at a Tuesday press conference in which House Democrats detailed a bill emergency spending of $28 million to address the shortage.

Across the country, parents are struggling to find infant formula due to a shortage caused by supply chain issues and exacerbated by a recall of formula made at an Abbott Laboratories plant in Michigan. Abbott issued the recall in February, as part of an FDA investigation into Cronobacter sakazakii infections in four babies who allegedly consumed formula made there. All four were hospitalized and Cronobacter may have contributed to the deaths of two babies, according to the FDA.

Pelosi did not say on Tuesday who might be charged, but said: “I think when all of this is done – I’m not associating my colleagues with what I’m going to say now, I’m just saying it myself – I think there might be a need for indictment.

Abbott reiterated in a statement Tuesday that “there is no conclusive evidence to link our formulas to reported childhood illnesses.” Abbott is already facing a number of lawsuits over it.

The FDA inspected the Abbott facility in Sturgis, Michigan, from January 31 to March 18 and found five environmental subsamples positive for Cronobacter sakazakii, although product samples collected by the FDA from the facility were negative for Cronobacter.

Abbott said the Cronobacter that was found during environmental testing during the investigation was in “non-product contact areas of the facility and has not been linked to any known childhood illnesses.”

Pelosi’s comments came after Rep. Rosa DeLauro, Democratic chair of the House Appropriations Committee, criticized Abbott and criticized the FDA on the issue at Tuesday’s press conference.

“In this case, … Abbott Nutrition is putting profits and products before people and, through a shameful lack of oversight, is now forcing parents and caregivers to struggle to feed their children,” DeLauro said. .

Abbott and the FDA reached an agreement Monday on steps the company must take before it can restart infant formula production at the Michigan plant. Abbott said it expects to be able to restart production within two weeks, once the FDA determines whether Abbott has met the initial requirements of the agreement, and that it may hand over some of its produced formulas to the plant on store shelves within six to eight weeks.

Abbott said it has resolved issues with plant processes and procedures that were identified during the FDA inspection. Abbott has reviewed and updated its education, training and safety procedures for employees and visitors; updated its water protocols and cleaning and maintenance procedures; and modernized the plant, including installing non-porous, “easily cleanable and sanitary” floors, Abbott said in an earlier statement.

Abbott is one of the few companies to produce the vast majority of the formula supply in the United States, so their recall wiped out much of the market.

DeLauro said the bill unveiled Tuesday would help the FDA take important steps to restore the supply of formula in a safe and secure manner.

The funding would increase FDA staffing focused on formula shortages to boost inspections, keep fraudulent products off store shelves and gain better market data, lawmakers said.

The House Appropriations Committee will hear from FDA Commissioner Robert Califf on Thursday to discuss the agency’s budget. Lawmakers should focus much of the discussion on formula shortages. A panel is also expected to hold a second hearing with experts who will discuss the recall of infant formula produced at Abbott’s plant and the FDA’s handling of the recall.

The House is expected to pass the emergency spending measure later this week before lawmakers return to their congressional districts for the next two weeks. The bill would also need to be approved by an equally divided Senate, where it will need the support of at least 10 Republicans before it can be signed into law.

It’s unclear where Republicans stand on the bill. Rep. Kay Granger, the ranking Republican on the House Appropriations Committee, said they needed more details.

“We want to do something,” Granger said. “We want to put more meat on the bone, more details of what needs to be done.”

“Too little too late,” added Rep. Ralph Norman, RS.C. “They should have seen this coming months ago.”

Meanwhile, the FDA is seeking to boost imports by streamlining its review process to make it easier for foreign manufacturers to start shipping more preparations to the United States.

In Illinois, Governor JB Pritzker’s administration said in a news release on Tuesday that it was encouraging retailers to reserve formula for low-income families enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children. the children.

The Illinois Department of Social Services has also trained social workers to help families with questions about forms who call its helpline at 1-800-843-6154, and state health officials. State urges families to purchase “modest” supplies of infant formula while shortages persist. .

“We have partnered with our providers and continue to expand our support centers to ensure our residents, especially low-income families, have what they need to care for their babies,” Pritzker said in a statement. hurry.

The Associated Press contributed.

lschencker@chicagotribune.com

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Post expires at 9:36pm on Tuesday June 21st, 2022