U.S. FDA Defends Baby Formula Shortage Response In Congress

The U.S. Food and Drug Administration on Wednesday in testimony to lawmakers defended the steps it took to address complaints about possible baby formula contamination at an Abbott Laboratories plant that has been closed since February.

FDA leaders are appearing before a congressional panel to answer questions about one of the biggest infant formula shortages in recent U.S. history after Abbott in February recalled some products and closed its manufacturing plant in Sturgis, Michigan.

It was critical to get the Sturgis plant online as soon as possible because it is one of three run by Abbott, which has the largest U.S. market share for infant formula, and because Abbott did not have a contingency plan to produce its lines of specialty formulas that serve as the only source of nutrition for thousands of babies with metabolic disorders, they said.

For the sake of expediency, the agency said it had little choice but to enter into a consent decree agreement with Abbott. The mechanism allows the company to avoid litigation by pledging to undertake voluntary actions to make improvements and address deficiencies under the oversight of outside officials like those from the FDA.

After the FDA inspection of the Sturgis facility, the consent decree was the only way for the FDA to have confidence in Abbott "where we literally have oversight of every single step" FDA Commissioner Dr. Robert Califf said in testimony before the U.S. House of Representatives Commerce and Energy Subcommittee on Oversight and Investigations.

Abbott said on Tuesday that it planned to reopen the plant on June 4.