This post was originally published on this site
https://i-invdn-com.investing.com/trkd-images/LYNXNPEI4O0VV_L.jpg
WASHINGTON (Reuters) -The U.S. Food and Drug Administration on Wednesday in testimony to lawmakers defended steps it took to address complaints about possible baby formula contamination at a now shuttered Abbott Laboratories (NYSE:ABT) plant that led to severe nationwide shortages.
FDA leaders appeared before a congressional panel to answer questions about the crisis after Abbott in February recalled some products and closed its manufacturing plant in Sturgis, Michigan.
The plant is one of three run by Abbott, which has the largest U.S. market share for infant formula, and the company did not have a contingency plan to produce its specialty formulas that serve as the only source of nutrition for thousands of babies with metabolic disorders, the FDA said.
For the sake of expediency, FDA Commissioner Dr. Robert Califf said the best option was to enter into a consent decree agreement with Abbott, allowing the agency to oversee improvement and remediation of problems at the facility to get it back on line as soon as possible.
The consent decree was the only way for the FDA to have confidence in Abbott “where we literally have oversight of every single step,” Califf told the U.S. House of Representatives Commerce and Energy Subcommittee on Oversight and Investigations.
Abbott said on Tuesday it planned to reopen the plant on June 4.
The FDA conducted an inspection of the plant following reports of bacterial infections in babies potentially linked to baby formula, and a whistleblower complaint from a former employee at the plant in late October.
A COVID outbreak at the Sturgis plant delayed an FDA inspection until Jan. 31. A second baby’s death potentially linked to the plant was reported just after the factory was shuttered on Feb. 17.
“Frankly, the inspection results were shocking,” Califf said, noting that inspectors found cracks in vital equipment, a lack of adequate hand washing, evidence of previous bacterial contamination, and water leaks in areas were formula is produced, a risk factor for bacteria.
Califf was questioned about the FDA’s delay in interviewing the former employee who complained about issues at the plant.
“It was too slow and there were decisions that were suboptimal along the way,” he acknowledged.
Top FDA leaders, including then-acting Commissioner Janet Woodcock, only received the complaint on Feb. 14 because of pandemic-related mail routing issues, they said in written testimony. Califf also blamed a lack of resources and overworked staff for problems at the agency.
“We have to figure out what we need to do to make these inspections robust,” said Diana DeGette, the subcommittee chairwoman.
Califf said the agency’s attempts to address shortages of infant formula through additional funding from Congress had failed in the past.
“We did a number of things at FDA to try to deal with it with the resources that we cobbled together,” he said.
