By Jennifer Shutt
U.S. Food and Drug Commissioner Robert Califf told Congress Thursday that the infant formula shortage will likely begin to improve in the coming days, though he declined to explain to unhappy lawmakers why his agency didn’t act sooner on a whistleblower report that detailed safety issues at an Abbott Laboratories facility in Michigan.
“We have an ongoing investigation about the details of exactly what happened, you know, from point A to point B along the way,” Califf said at a tense U.S. House hearing. “Since it is ongoing, I can’t give extensive more details on that part of it.”
Democrats and Republicans on the U.S. House subcommittee in charge of the FDA’s funding were equally annoyed with that answer, pressing Califf to explain why it took months for the FDA to inspect the plant and for Abbott to issue a voluntary recall.
Georgia Democratic Rep. Sanford Bishop, the subcommittee chair, said during the hearing he was “disturbed by the length of time that it took for FDA to really start to address this problem” and for the “nonspecific and vague way” officials have implemented a plan to address the shortage.
The FDA received a whistleblower report in October 2021 alleging Abbott officials falsified records, released untested infant formula and hid information during a 2019 FDA audit.
Officials didn’t interview the whistleblower until late December and didn’t inspect the plant until Jan. 31, according to U.S. lawmakers.
For the complete story, see the Oregon Capital Chronicle.
Has this lack luster FDA performance been the standard level of process execution? Because I’m sure this isn’t the 1st time such a snafu has occurred at any food processing plant. What was so significant about this time at Abbott that resulted in this catastrophic loss of this vital food item?
Has there been any changed in the process of handling this type of situation? If so when, why and who is responsible for that short sightedness?
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