The Food and Drug Administration has finally acknowledged that its response to the US infant formula shortage was caused by a number of issues.
The agency said this included delays in handling a whistleblower complaint about bacterially contaminated baby formula from the country’s largest formula factory.
One report found it failed to quickly process reports of contamination at a Sturgis, Michigan formula plant owned by formula maker Abbot due to a serious breakdown in intermediate steps in the reaction process.
“The situation at the Abbott Sturgis facility has highlighted how little authority the FDA has to compel many companies to ‘do the right thing,’ without intervention,” FDA Commissioner Robert Califf said in a statement.
This contamination is believed to have caused it the illness of four infants and the death of two.
The Food and Drug Administration on Tuesday acknowledged that its response to the US infant formula shortage was caused by a number of issues, including delays in handling a whistleblower complaint about bacterially contaminated baby formula from the country’s largest infant formula factory
The agency’s 10-page report offers its first formal account of the factors that led to the ongoing shortages that have forced the US to ship millions of pounds of powdered formula overseas.
The review focused on several key issues facing the agency, including outdated data-sharing systems, insufficient staffing and training of food inspectors, and poor visibility into formula food supply chains and manufacturing processes.
“With things critical to public health, if you don’t understand how all the pieces fit together, you have a real problem when you hit a crisis or shortage,” Califf told The Associated Press in an interview. “To a large extent, that’s what happened here.”
Califf said the FDA will seek new authority to compel companies to release critical information.
The massive shortage of baby food led to parents across the country paying exorbitant prices for standard formula, scrambling to make homemade formulas and criticizing President Biden for starving American babies.
A 10-page report from the agency offers its first formal account of the factors that led to the ongoing shortages that have forced the US to ship millions of pounds of powdered formula overseas
A consumer advocate said the assessment doesn’t go far enough to fix the problems.
“This internal assessment addresses the symptoms of the disease rather than offering a cure,” Scott Faber of the Environmental Working Group said in a statement. “Nothing in this review addresses the fragmented leadership structure that has led to critical communication failures.”
The FDA report was overseen by a senior official who interviewed dozens of agency employees. It comes nearly eight months after the FDA shut Abbott’s Michigan plant over safety concerns and quickly cut domestic production within the highly concentrated formula industry.
A company whistleblower had tried to warn the FDA of problems at the facility in September 2021, but government inspectors didn’t investigate the complaints until February, after four infants fell ill, resulting in two deaths.
The FDA is still investigating links between these diseases and the formula.
The review focused on several key issues facing the agency, including outdated data-sharing systems, insufficient staffing and training of food inspectors, and poor visibility into formula food supply chains and manufacturing processes
The FDA report was overseen by a senior official who interviewed dozens of agency employees
The FDA previously told Congress that senior agency officials only learned of the complaint in February because of delays in the mail and the Abbott employee’s allegations were not escalated.
The new report said the FDA’s “inadequate processes and lack of clarity regarding whistleblower complaints” may have prevented inspectors from coming to the facility.
“Whistleblower complaints come into the agency in many different ways and from many different sources,” said Dr. Steven Solomon, an FDA veterinarian who oversaw the review. “One of the actions we’ve already taken is to ensure that regardless of whether they come into the agency, they’re triaged and escalated to the right levels of leadership.”
FDA inspectors collected bacterial samples from the facility for testing, but shipping issues at “third-party shipping companies” delayed the results, the report said. The FDA has also faced challenges ramping up its testing capacity for Cronobacter, a rare but potentially deadly bacterium that has been repeatedly linked to outbreaks in baby food.
The FDA also noted that it had to postpone its initial inspection of Abbott’s facility due to COVID-19 cases among company employees. This delay came on top of previous missed inspections because the agency pulled its inspectors off the field during the pandemic.
The report concluded by listing new resources that Congress would need to authorize to improve infant formula inspections and standards, including:
– Increased funding and hiring capabilities to recruit experts for the Food Division of the FDA;
– Enhanced information technology to share data on FDA inspections, consumer complaints and test results;
– New power to force manufacturers to release samples and records of manufacturing supply chains, manufacturing quality and safety.
The massive baby formula shortages last spring caused parents across the country to pay exorbitant prices for standard formula, scramble to make homemade formulas and criticize President Biden for starving American babies
A company whistleblower had tried to warn the FDA of problems at the facility in September 2021, but government inspectors didn’t investigate the complaints until February, after four infants fell ill, resulting in two deaths
According to IRI, a market research firm, U.S. baby formula inventories have improved, taking inventories to over 80 percent last week. That’s up from a low of 69 percent in mid-July.
The US has imported the equivalent of more than 80 million bottles of formula since May, according to the White House, and the Biden administration is working to help foreign manufacturers stay in the market long-term to diversify supply.
Califf commissioned a separate external review of the FDA’s Food Division that identified “fundamental issues surrounding the structure, function, funding, and governance” of the program.
This review is led by former FDA Commissioner Dr. Jane Henney, who headed the agency in the final years of the Clinton administration.