By Cara Murez HealthDay Reporter
HealthDay Reporter
WEDNESDAY, Sept. 21, 2022 (HealthDay News) – In a report issued Tuesday, the U.S. Food and Drug Administration acknowledged numerous shortcomings in its response to the infant formula shortage earlier this year.
“For things that are critical to the public health, if you don’t have some understanding of how all the pieces fit together, then when you get into a crisis or a shortage you have a real problem,” FDA Commissioner Robert Califf told the Associated Press. “To a large extent, that’s what happened here.”
The report highlighted several problems, including outdated data-sharing systems and low staffing levels for food inspectors. Poor insight was also provided by the agency into infant formula supply chains and manufacturing processes.
The 10-page report comes eight months after the agency closed Abbott’s infant formula plant in Michigan amid safety concerns and reports of illness in infants. The agency interviewed approximately 60 employees during the review.
Although a whistleblower had tried to warn the FDA about problems in September 2021, the agency didn’t investigate until the following February.
Four infants had fallen ill by that time, and two of them had already died. FDA continues to investigate whether the formula and these infants are connected. AP reported.
“Whistleblower complaints come into the agency in many different ways, from many different sources,” Dr. Steven Solomon, director of the Center for Veterinary Medicine and the person who oversaw the review, told the AP. “One of the actions we’ve already taken is to make sure that however they come into the agency, they get triaged and escalated to the right leadership levels.”
Mail delays were one of the reasons the FDA didn’t learn about the complaint earlier, according to information the agency gave Congress. Another reason was the failure to escalate whistleblower claims.
The FDA’s “inadequate processes and lack of clarity related to whistleblower complaint” likely contributed to delays, according to the report.
Shipping issues experienced by “third party delivery companies” further caused delays in testing bacterial samples and the agency struggled with its testing capacity for the rare but potentially deadly CronobacterThe infant formula outbreak was caused by bacteria.
Continued
Further problems were also caused by the pandemic. This was both because the agency missed inspections when it removed inspectors from the field, but also because of COVID infections among agency staff.
FDA intends to seek new authority to require companies to submit samples and records about manufacturing supply chains, quality, safety and quality.
The report asked Congress for funding to improve standards and inspections of infant formula. This would increase funding and hiring authority for new experts in the FDA’s food division, as well as improve technology to share data on FDA inspections, consumer complaints and testing results.
Still, the report doesn’t go far enough, Scott Faber, of the Environmental Working Group, said in a statement.
“This internal evaluation treats the symptoms of the disease rather than offering a cure,” Faber said. “Nothing in this evaluation addresses the fragmented leadership structure that led to critical communication failures.”
The February problem at Abbott resulted in significant formula shortages. In the end, the United States was able to airlift approximately 80 million formula bottles from foreign countries.
Additional information
More information can be found at the U.S. Centers for Disease Control and Prevention. Cronobacter .
