The Biden administration is pulling every lever to expedite the delivery of baby formula across America. Invoking the Defense Production Act and sourcing supplies overseas through its “Operation Fly Formula” initiative will hopefully bring cans to store shelves over the next few weeks. For worried families, it can’t happen fast enough.
Abbott Nutrition issued a recall of certain lots of three powdered formulas and suspended operations at its Michigan-based plant back in February when four incidents of bacterial infection were potentially linked to the products. Two infants died. The plant was shut down for nearly three months as the U.S. Food and Drug Administration (FDA) conducted its investigation.
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The availability of formula brands was already dwindling due to global pandemic-related supply chain issues. With Abbott Nutrition controlling nearly 40 percent of the U.S. formula supply before the recall, the FDA — led by recently-confirmed Commissioner Dr. Robert Califf — should have predicted what would happen next.
All it took was the Michigan facility going offline to push a stressed formula industry to the brink and put the survival of millions of infants at risk. The warning signs were there — and for months the FDA did little, if anything, to get in front of it. Making matters worse, an understaffed FDA apparently ignored a complaint from a whistleblower last October alleging safety violations and failures in testing procedures at the Abbott facility.
We trust our elected leaders to ensure competition exists across every industry so that the interests of Americans are best served. This year Congress has been aggressively pursuing the tech industry to prevent one company from having greater market control over others. Why was the baby formula industry — a lifeline for many American families — given permission to operate this way?
Sen. Cory Booker (D-N.J.) and others are now demanding answers as to why the manufacturing of baby formula in the United States is dependent on such a small number of companies and facilities that produce it, and are exploring ways to address it.
The immediate need to boost American production of infant formula is obvious — but it cannot come at the expense of public safety. The FDA had been investigating Abbott’s Michigan facility for nearly three months since the recall went into effect — but it was only days after the formula shortage became a full-blown crisis that the FDA arrived at an agreement with Abbott to bring the Michigan plant back online.
Was this timing a coincidence, or was the pressure so intense on the FDA to reach a resolution with Abbott that it did so before completing its thorough investigation into the bacterial infections and deaths that led to the plant’s shutdown in the first place? How can the FDA help restore confidence in its inspection processes?
Parents are desperately awaiting cans of formula to appear at their local stores. But they must be certain these products will be safe for their children to consume. The FDA can regain this trust — but only if it communicates, clearly, the corrective actions Abbott took to ensure the problems that led to the recall won’t be repeated.
The FDA needs proper resources to manage this problem. Yet when elected leaders in Congress try to politicize the situation by voting against FDA funding to help the agency deal with this crisis, it sends the wrong message.
Government leaders must learn from this experience by anticipating how market variables can affect our nation’s most vulnerable populations, and taking action before they erupt into full-blown public health emergencies. Longer-term competition must be fortified so that the closure of one plant doesn’t put us in this same predicament again. At a minimum, we must have contingency plans in place to ensure ready food supplies exist so that American children are not at risk of dying from either unsafe manufacturing or faults in the supply chain.
We can all agree on that.
The U.S. Centers for Disease Control and Prevention estimates nearly 20 percent of infants under two consume baby formula to supplement their early nutrition. These innocent children are entirely reliant on the collective responsibility we share to make decisions that protect their wellbeing. We failed them. We can, and must, do better.
Lyndon Haviland, DrPH, MPH, is a distinguished scholar at the CUNY School of Public Health and Health Policy.