“Corporate greed and dereliction of duty”: FDA commissioner slammed over infant formula shortage

20 May 2022 --- US Food and Drug Administration (FDA) Commissioner Dr. Robert Califf was grilled by lawmakers during a House Appropriations subcommittee hearing, where he was slammed over the agency’s handling of the escalating infant formula shortage.

“We need to get to the bottom of the FDA’s slow response, which contributed to products staying on the shelf and in the homes of families the country over, potentially putting babies at risk and forcing parents to play a game of Russian Roulette that they did not know they would be playing,” said committee chair Rosa DeLauro in her opening statement.

The situation has led US President Joe Biden to invoke the Defense Production Act, a wartime tool the state can use to prioritize the production of specific products.

Califf was accused of inaction leaving parents scrambling to find formula amid empty shelves and price gouging now proliferating the market. Bodies such as the FDA and the American Academy of Pediatrics strongly warned against watering down baby formula or homemade recipes due to risks of seizure as parents become increasingly desperate. 

“The shortage was caused in large part by the lack of action by the FDA and by corporate greed and consolidation. In this case, Abbott putting profits and production over people,” DeLauro underscores.

Doctors fear deficiencies stemming from loss of nutrition could be very serious.Concentrated industry
The US produces 98% of the baby formula for its population, limited to a pool of four main manufacturers – Abbott, Mead Johnson Nutrition, Nestlé and Perrigo. 

“This crisis has shown us the impact of having a single manufacturer cease production for a brief period. Unless we strengthen the resilience of our supply chain, we could be one natural disaster, quality mishap or cyber-attack from being here again,” Califf told lawmakers.

“The US was facing infant formula supply chain stress even before the Abbott Nutrition recall that began in February. Pandemic, the war in Ukraine and labor supply issues have all had an impact, and I can assure you the FDA has been working tirelessly to address this issue.”

Earlier this week, Abbott announced it reached an agreement with the FDA to reopen its Sturgis facility in around two weeks, in a bid to tackle the problem.

Whistleblower reveal on deaf ears
Lawmakers also accused the FDA of inaction surrounding a whistleblower complaint. Agency officials received a document from a whistleblower in October, detailing poor safety practices at Abbott’s Sturgis facility, and accusations of intentionally hiding things from FDA inspectors.

The whistleblower was interviewed in December.

“If the allegations are true, the company has lied, cut corners, falsified records to cover up their misdoings at the risk of infant health and retaliate against employees who tried to correct the problems they were seeing. They knowingly put a contaminated product on the market. That is plain wrong,” DeLauro said.

Since then, two infants have died, and a number have been hospitalized. Abbott voluntarily recalled its potentially affected products, including Similac, Alimentum and EleCare powdered formulas manufactured at its Sturgis facility in Michigan.

A subsequent investigation carried out in April by the FDA revealed damning observations, including the absence of a process control system that could ensure infant formula does not become adulterated. Additionally, Abbott failed to ensure that all surfaces in contact with infant formula were maintained to protect the product from being contaminated by any source, according to the FDA. Five environmental subsamples were found positive for Cronobacter sakazakii, the investigation revealed.

The market is dominated by a handful of companies.

Silence unwelcome
Pressed by lawmakers on the delayed action by the FDA, Califf evaded giving concrete answers, pending an investigation. 

“We have an ongoing investigation about the details of exactly what happened, you know, from point A to point B along the way. Since it is ongoing, I can’t give extensive more details on that part of it.”

Congressman Mark Pocan described Califf’s silence as unacceptable. “It’s not acceptable to say that you can’t comment on it. The public wants to know.”

“How many more illnesses and deaths were caused due to the FDA ‘slow response?” DeLauro questioned. “Why was there no reaction? It makes me question which side the FDA is on. Are they on the side of Abbott and industry, or are they on the side of the American consumer, in this case babies and their moms and dads?”

Bills attempt to salvage problem
Nestlé also announced it partnered with the US administration in a bid to expedite the import of formula. Specifically, the company will bring 132 pallets of Alfamino Infant and Alfamino Junior, and 114 pallets of Gerber Good Start Extensive HA to the US. 

“This will add the equivalent of approximately 1.5 million 8-ounce bottles of formula into the market for babies. We prioritized these products because they serve a critical medical purpose as they are for babies with cow’s milk protein allergies,” Nestlé outlines.

As part of Biden’s Operation Fly Formula, commercial aircraft are authorized to fly formula supplies that meet federal standards from overseas to the US. Under the Defense Production Act, suppliers of formula manufacturers have to fulfill orders from those companies before other customers. 

On Wednesday, the US passed two bills to boost infant formula supply. The supplemental funding bill provides the FDA with resources to help address the infant formula shortage, increase the number of FDA inspection staff, provide resources for personnel working on formula issues, help the agency stop fraudulent and unsafe baby formula from entering the marketplace, and improve data collection on the formula market.

The Access to Baby Formula Act provides flexibility so that low-income families can continue purchasing safe infant formula with benefits during a crisis, such as a supply chain disruption.

Retailers and pharmacies across the US, such as Target, Walmart, CVS and Walgreens, have implemented restrictions on the amount of formula parents can buy in an attempt to ensure continued supply. 

By Andria Kades