The FDA FINALLY admits delays in response to the shortage of infant formula

The Food and Drug Administration has finally acknowledged that its response to the shortage of infant formula in the United States was caused by a number of problems.

The agency said this included delays in processing a complaint by a whistleblower about bacterial-contaminated infant formula from the nation’s largest infant formula.

One report found that it failed to quickly route reports of contamination at a formula facility in Sturgis, Michigan, belonging to formula maker Abbot, due to a major disruption in the middle stages of the response process.

“The situation at the Abbott Sturgis plant highlighted how little authority the FDA has to force many companies to” do the right thing “without intervention,” FDA Commissioner Robert Califf said in a statement.

Such contamination is believed to have led to the illness of four children and the death of two.

The Food and Drug Administration acknowledged Tuesday that its response to the U.S. infant formula shortage was caused by a number of problems, including delays in processing a whistleblower complaint about bacterial-contaminated infant formula. from the nation’s largest infant formula factory

The agency’s 10-page report offers its first formal account of the factors that led to the ongoing shortage, which forced the United States to fly millions of pounds of formula powder from overseas.

The review focused on several key issues for the agency, including stale data sharing systems, inadequate staffing and training among its food inspectors, and poor visibility into formula supply chains and manufacturing procedures.

“For the things that are critical to public health, if you don’t have some understanding of how all the pieces fit together, then when you get into a crisis or shortage you have a real problem,” Califf told The Associated Press in an interview. “To a large extent that’s what happened here.”

Califf said the FDA will seek a new authority to compel companies to provide key information.

The massive shortage of baby formulas has left parents across the country paying exorbitant prices for standard formulas, struggling to produce homemade formulas, and criticizing President Biden for allowing American children to go hungry.

A 10-page report from the agency offers its first formal account of the factors that led to the ongoing shortage, which forced the U.S. to fly millions of pounds of formula powder from overseas.

A 10-page report from the agency offers its first formal account of the factors that led to the ongoing shortage, which forced the U.S. to fly millions of pounds of formula powder from overseas.

A consumer advocate said evaluation doesn’t go far enough to solve problems.

“This internal evaluation treats the symptoms of the disease rather than offering a cure,” Scott Faber of the Environmental Working Group said in a statement. “Nothing in this assessment addresses the fragmented leadership structure that has led to critical communication errors.”

The FDA report was overseen by a senior official who interviewed dozens of the agency’s staff members. It comes nearly eight months after the FDA closed Abbott’s Michigan plant due to safety concerns, quickly cutting in-house manufacturing within the highly concentrated formula industry.

A company whistleblower had tried to alert the FDA of problems at the plant in September 2021, but government inspectors did not investigate the complaints until February after four children fell ill, resulting in two deaths.

The FDA is still studying the links between those diseases and the formula.

The review focused on several key issues for the agency, including stale data sharing systems, inadequate staffing and training among its food inspectors, and poor visibility into formula supply chains and manufacturing procedures.

The review focused on several key issues for the agency, including stale data sharing systems, inadequate staffing and training among its food inspectors, and poor visibility into formula supply chains and manufacturing procedures.

The FDA report was overseen by a senior official who interviewed dozens of agency staff members

The FDA report was overseen by a senior official who interviewed dozens of agency staff members

The FDA had previously told Congress that the agency’s top officials were unaware of the complaint until February due to mail delays and the lack of escalation of employee Abbott’s allegations.

The new report said the FDA’s “inadequate processes and lack of clarity regarding whistleblower complaints” may have delayed the arrival of inspectors at the plant.

“Whistleblower complaints come to the agency in many different ways, from many different sources,” said Dr. Steven Solomon, an FDA veterinary medicine officer who oversaw the review. “One of the actions we have already taken is to make sure that no matter how they join the agency, they are selected and brought to the right levels of leadership.”

FDA inspectors collected bacterial samples from the facility for testing, but shipping issues from “third-party delivery companies” delayed the results, according to the report. The FDA has also faced challenges to increase its testing capacity for cronobacter, a rare but potentially deadly bacterium repeatedly linked to outbreaks in infant formula.

The FDA also noted that it had to reschedule its initial inspection of the Abbott plant due to cases of COVID-19 among company personnel. That delay added to previous missed inspections because the agency withdrew its inspectors from the field during the pandemic.

The report concluded by listing the new resources Congress would need to authorize to improve infant formula inspections and standards, including:

– Increased funding and hiring authority to recruit experts in the FDA’s food division;

– Improved information technology to share data on FDA inspections, consumer complaints and test results;

– New authority to oblige manufacturers to deliver samples and records on production supply chains, production quality and safety.

The massive shortage of baby formulas last spring left parents across the country paying exorbitant prices for standard formulas, struggling to produce homemade formulas, and criticizing President Biden for allowing American children to go hungry.

The massive shortage of baby formulas last spring left parents across the country paying exorbitant prices for standard formulas, struggling to produce homemade formulas, and criticizing President Biden for allowing American children to go hungry.

A company whistleblower had tried to alert the FDA of problems at the plant in September 2021, but government inspectors did not investigate the complaints until February after four children fell ill, resulting in two deaths.

A company whistleblower had tried to alert the FDA of problems at the plant in September 2021, but government inspectors did not investigate the complaints until February after four children fell ill, resulting in two deaths.

According to IRI, a market research firm, U.S. infant formula stocks have improved, hitting inventory rates above 80% last week. This is up from a low of 69 percent in mid-July.

The United States has imported the equivalent of more than 80 million bottles of formula since May, according to White House data, and the Biden administration is working to help foreign manufacturers stay in the long-term market to diversify supply. .

Califf commissioned a separate external review of the food division of the FDA citing “key questions about the structure, function, funding and leadership” of the program.

That review is led by former FDA commissioner Dr. Jane Henney, who led the agency during the last few years of the Clinton administration.

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