FDA Takes Responsibility for Infant Formula Failures

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In a world where so few people at the top take responsibility for failure, the FDA’s top official is acknowledging a number of mistakes that contributed to the infant formula crisis. He appeared in front of lawmakers this week on Capitol Hill.

Robert Califf, the FDA commissioner prepared a testimony that was released to the public. He was joined by several senior officials and then laid out a timeline regarding how the agency responded to reports last fall that infants had been hospitalized after receiving formula made at the Abbott Nutrition plant in Sturgis, Michigan.

They revealed that the highest levels of the FDA did not receive a whistleblower report alleging that there were food safety problems at the plant until mid-February of this year, even though it was submitted in October of last year. The report had been sent directly to then-acting Commissioner Janet Woodcock and others in leadership.

The plant in Michigan was shut down temporarily in February after the FDA did an inspection in January and found five different strains of a potentially deadly bacteria that is called Cronobacter sakazakii. This bacteria caused four infants to get sick and two of them died from the sickness.

Abbott also immediately recalled some of the formulas that were made at the plant which caused the shortage of infant formula to increase during the pandemic.

The FDA is right in the middle of a political fight over the shortages as parents are searching for alternative ways to feed their children. If your child needs a specialty formula because of health conditions, the situation can be dire. Some of these children have already ended up in the hospital.

Previously, the FDA was not commenting on why it has taken months between the first report of a bacterial infection linked to the Michigan plant and the report issued this week. Some believe that the FDA report this week will fuel even more outrage from parents and lawmakers.

Rosa DeLauro, a Democratic representative from Connecticut who is the House Appropriations Committee chair, said in a recent interview, “The FDA, at every step of this process, dropped the ball. It put infants at risk.”

In the timeline that the FDA made public, it revealed that they did not even have interagency discussions about the potential for supply chain issues until mid-February. This was just three days before the Abbott Nutrition Plant shut down and issued to recall of the formula.

The agency did not let the Agriculture Department know about potential disruptions until one week before Abbott shut down. This is the department that oversees the federal nutrition program, WIC, which buys approximately half of America’s infant formula and serves 1.2 million infants from low-income families. Abbott was responsible for supplying almost half of all infant formula that WIC provides through state contracts.

The report from the FDA lays some blame on “mailroom issues.” They say that top FDA officials did not receive hard copies of the whistleblower report given in October that detailed poor food safety practices and falsified documents.

The FDA maintains that “since the first day…has worked tirelessly with U.S. government partners to mitigate the supply chain disruption for both regular and specialty formulas.” But the question still looms about why it wasn’t until May 16 that the FDA and Abbott agreed on a deal to reopen the plant.

The White House has failed to answer questions about its timeline in this crisis, and a senior administration official indicated that they would not comment on “internal communications.”

Maybe Biden should take some cues from the FDA on taking responsibility.