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FDA FINALLY concedes delays in response to baby formula shortage

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

The agency said these included delays in processing a whistleblower complaint about bacterially tainted baby formula from the nation’s largest formula factory.

A report found it failed to rapidly address reports of contamination at a formula facility in Sturgis, Michigan, belonging to the formula maker Abbot, because of a serious breakdown in intermediary steps in the response process.

‘The situation at the Abbott Sturgis facility has highlighted just 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.

That contamination is believed to have led to the illness of four infants, and the deaths of two.

The Food and Drug Administration acknowledged Tuesday that its response to the US infant formula shortage was caused by a number of problems, including delays in processing a whistleblower complaint about bacterially tainted baby formula from the nation’s largest formula factory

The 10-page report from the agency offers its first formal account of the factors that led to the ongoing shortage, which has forced the US to airlift millions of pounds of powdered formula from overseas.

The review zeroed in on several key problems at the agency, including outdated data-sharing systems, inadequate staffing and training among its food inspectors, and poor visibility into formula supply chains and manufacturing procedures.

‘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,’ 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 turn over key information.

Massive shortages of baby formula left parents across the country paying exorbitant prices for standard formulas, scrambling to make homemade formula, and slamming President Biden for allowing American babies 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 has forced the US to airlift millions of pounds of powdered formula from overseas

A 10-page report from the agency offers its first formal account of the factors that led to the ongoing shortage, which has forced the US to airlift millions of pounds of powdered formula from overseas

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 of the Environmental Working Group said in a statement. ‘Nothing in this evaluation addresses the fragmented leadership structure that led to critical communication failures.’

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

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.

The FDA is still investigating links between those illnesses and the formula.

The review zeroed in on several key problems at the agency, including outdated data-sharing systems, inadequate staffing and training among its food inspectors, and poor visibility into formula supply chains and manufacturing procedures

The review zeroed in on several key problems at the agency, including outdated 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 staffers

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

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 claims.

The new report stated that FDA’s ‘inadequate processes and lack of clarity related to whistleblower complaints,’ may have delayed getting inspectors to the plant.

‘Whistleblower complaints come into the agency in many different ways, from many different sources,’ said Dr. Steven Solomon, an FDA veterinary medicine official who oversaw the 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 collected bacterial samples from the plant for testing, but shipping issues by ‘third party delivery companies’ delayed the results, according to the report. The FDA also faced challenges ramping up its testing capacity for cronobacter, a rare but potentially deadly bacteria repeatedly linked to outbreaks in baby 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 staff. That delay came on top of earlier missed inspections because the agency pulled its inspectors from 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 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.

Massive shortages of baby formula last spring left parents across the country paying exorbitant prices for standard formulas, scrambling to make homemade formula, and slamming President Biden for allowing American babies to go hungry

Massive shortages of baby formula last spring left parents across the country paying exorbitant prices for standard formulas, scrambling to make homemade formula, and slamming President Biden for allowing American babies to go hungry

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

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

US inventors of baby formula have been improving, hitting in-stock rates above 80 percent last week, according to IRI, a market research firm. 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 White House figures, and the Biden administration is working to help foreign manufacturers stay on the market long term to diversify supply.

Califf has commissioned a separate external review of the FDA’s food division citing ‘fundamental questions about the structure, function, funding and leadership’ of the program.

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

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