The Food and Drug Administration acknowledged Tuesday that its response to the U.S. infant formula shortage was slowed by delays in processing a whistleblower complaint and test samples from the nation’s largest formula factory.
The agency’s 10-page report provides the first official account of what caused the continuing shortage. This has led the United States to fly millions of pounds worth of powdered formula to other countries.
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This review focused on key issues at the agency such as outdated data-sharing and inadequate training for its inspectors and lack of visibility into manufacturing processes and formula supply chains.
“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,”Robert Califf, FDA Commissioner, spoke to The Associated Press during an interview. “To a large extent that’s what happened here.”
Califf stated that the FDA would seek additional authority to force companies to disclose key information.
One consumer advocate said the evaluation doesn’t go far enough to fix the problems.
“This internal evaluation treats the symptoms of the disease rather than offering a cure,”Scott Faber from the Environmental Working Group made this statement. “Nothing in this evaluation addresses the fragmented leadership structure that led to critical communication failures.”
An FDA senior official overseen the report after interviewing dozens of staffers. It comes nearly eight months after the FDA shuttered Abbott’s Michigan plant due to safety concerns, quickly slashing domestic production within the highly concentrated formula industry.
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A company whistleblower had tried to warn the FDA of problems at the plant in September 2021, but government inspectors didn’t investigate the complaints until February after four infants became sick, resulting in two deaths. FDA still investigates the possible link between those diseases and the formula.
The FDA previously told Congress that top agency officials didn’t learn about the complaint until February because of mail delays and a failure to escalate the Abbott employee’s allegations. The new report stated that FDA’s “inadequate processes and lack of clarity related to whistleblower complaints,”An inspector may not have been able to reach the plant in time.
“Whistleblower complaints come into the agency in many different ways, from many different sources,”According to Dr. Steven Solomon of FDA, a veterinary medicine officer who oversaw this review. “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.”
FDA inspectors took bacterial samples from the plants for testing. However, shipping concerns were not addressed by them. “third party delivery companies”According to the report, delays caused by cronobacter result delayed. FDA faced difficulties in increasing its testing capabilities for cronobacter. Cronobacter is a deadly, rare bacteria that has been repeatedly linked with baby formula outbreaks.
Also, FDA noted that its original inspection of Abbott had to be rescheduled due to COVID-19-related cases in company employees. This delay was in addition to earlier missed inspections due to the fact that the FDA pulled inspectors out of the field during the Pandemic.
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In conclusion, the report listed new resources Congress should authorize in order to increase infant formula inspections.
— Increased funding and hiring authority to recruit experts to FDA’s food division;
— Improved information technology to share data on FDA inspections, consumer complaints and testing results;
— New authority to compel manufacturers to turn over samples and records on manufacturing supply chains, manufacturing quality and safety.
The U.S. stockpiles of baby formula are increasing and reached in-stock rates over 80% last Wednesday, according IRI, an independent market research firm. That’s up from a low of 69% in mid-July. Based on White House data, more than 80 million formula bottles have been imported by the United States since May. According to the Biden administration, foreign companies are encouraged to stay in the US market over the long term, diversifying supply.
Califf has commissioned a separate external review of FDA’s food division citing “fundamental questions about the structure, function, funding and leadership”The program. Jane Henney (ex-FDA commissioner) is leading the review. Jane Henney was the former director of FDA during Clinton’s final years.
This article was contributed by the Associated Press
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