House Speaker Nancy Pelosi said indictments may be filed over a shortage of infant formula, during a news conference Tuesday in which House Democrats detailed a $28 million emergency spending bill to address the shortage.
Parents across the country have been struggling to find infant formula because of a shortage sparked by supply chain issues and exacerbated by a recall of formulas made at an Abbott Laboratories plant in Michigan. Abbott issued the recall in February, amid an FDA investigation into Cronobacter sakazakii infections among four babies who reportedly consumed formula made there. All four were hospitalized, and Cronobacter may have contributed to two babies’ death, according to the FDA.
Pelosi did not say Tuesday who might be indicted but said, “I think that when all of this is done — I’m not associating my colleagues with what I’m going to say right 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 the reported infant illnesses.” Abbott is already facing a number of lawsuits over the matter.
The FDA inspected Abbott’s Sturgis, Michigan, facility from Jan. 31 through March 18 and found five environmental subsamples to be positive for Cronobacter sakazakii, though product samples collected by the FDA at the facility were negative for Cronobacter.
Abbott has said the Cronobacter that was found in environmental testing during the investigation was in “non-product contact areas of the facility and has not been linked to any known infant illness.”
Pelosi’s comments came after Rep. Rosa DeLauro, the Democratic chair of the House Appropriations Committee, slammed Abbott and criticized the FDA over the issue during the news conference Tuesday.
“In this case, … Abbott Nutrition put profits and product over people and due to what is a disgraceful lack of oversight, is now causing parents and caregivers to struggle to feed their kids,” DeLauro said.
Abbott and the FDA reached an agreement Monday on the steps the company must take before it can restart production of infant formula at the Michigan facility. Abbott has said that it expects to be able to restart production within two weeks, once the FDA determines if Abbott has met the initial requirements of the agreement, and it could have some of its formulas produced at the plant back on store shelves within six to eight weeks after that.
Abbott has said it has addressed problems with processes and procedures at the plant that were identified during the FDA inspection. Abbott has reviewed and updated its education, training and safety procedures for employees and visitors; updated its protocols related to water and cleaning and maintenance procedures; and has been upgrading the plant, including by installing nonporous, “easily cleanable and sanitary floors,” Abbott said in an earlier statement.
Abbott is one of only a handful of companies that produce the vast majority of the U.S. formula supply, so their recall wiped out a large segment of the market.
DeLauro said the bill unveiled Tuesday would help the FDA take important steps to restore the formula supply in a safe and secure manner.
The funding would increase FDA staffing focused on the formula shortage to boost inspections, prevent fraudulent products from getting onto store shelves and acquire better data on the marketplace, lawmakers said.
The House Appropriations Committee will hear from FDA Commissioner Robert Califf on Thursday to discuss the agency’s budget. Lawmakers are expected to focus much of the discussion on the formula shortage. A panel is also expected to have a second hearing featuring experts who will discuss the recall of infant formula produced at the Abbott facility and the FDA’s handling of the recall.
The House is expected to take up the emergency spending measure later this week before lawmakers head back to their congressional districts for the next two weeks. The bill would also need approval in an evenly divided Senate, where it will need support from at least 10 Republicans before it could 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 need more details.
“We want to do something,” Granger said. “We want to put more meat on the bone, more specifics on what needs to be done.”
“Too little too late,” added Rep. Ralph Norman, R-S.C. “They should have seen this coming months ago.”
Meanwhile, the FDA is looking to boost imports by streamlining its review process to make it easier for foreign manufacturers to begin shipping more formula into the U.S.
In Illinois, Gov. J.B. Pritzker’s administration said Tuesday in a news release that it’s encouraging retailers to set aside formula for low-income families enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children program.
The Illinois Department of Human Services has also trained caseworkers to help families with formula questions who call its help line at 1-800-843-6154, and state public health officials are urging families to buy “modest” supplies of formula while the shortage persists.
“We’ve partnered with our suppliers and continue to ramp up our support centers to ensure our residents, especially low-income families, have what they need to care for their babies,” Pritzker said in a news release.
The Associated Press contributed.