Formula Fail
Biden team didn’t learn key COVID lessons
WHO’S to blame for the baby-formula shortage and why is it taking so long to fix the problem? There are no easy answers, but there are a lot of important ones — and many of them ratchet all the way up to the Oval Office.
The shortage’s immediate cause was grossly inadequate safety protocols on the part of a major manufacturer, Abbott Nutrition. The Food and Drug Administration inspected the Michigan facility in February, uncovered inexcusable safety lapses and closed it — and rightly so.
The bad news is from February until now is not a long time in manufacturing remediation. Before the FDA could oversee corrective measures, the agency had to spend weeks identifying everything that needed remediation.
Abbott and the FDA had to develop a plan to address all the deficiencies — a few more weeks. Then they needed a plan to address the safety and quality issues. Finally, once that was in place, the hard work of fixing the problems — including Abbott’s culture of noncompliance — could begin.
The FDA made the right regulatory move. It then contacted the remaining large baby-formula manufacturers and asked them to ramp up production. That’s one reason the shortage isn’t worse.
But it should have also been developing a plan to allow for the importation of baby formula made in other countries — which the FDA has only just begun.
A key question is: What did the White House know and when did it know it? Considering that it took President Biden more than a year to appoint a new FDA commissioner, we can surmise that the agency and its many issues weren’t at the top of his or his team’s agenda. That’s an inexcusable mistake considering the FDA regulates about a third of the US economy and is a major player in our COVID-19 battle. Despite some light media coverage in February, it’s unlikely the president’s team even knew about the baby-formula situation before it became a national crisis.
An attentive White House should have recognized shortages were coming and communicated the situation to American parents while empowering the FDA to work with major retailers to avoid product panic buying by parents and hoarding by Internet price gougers (who should be named, shamed and hung up by their thumbs). Such advance warning would have allowed parents to better prepare and the go-to professionals (especially pediatricians) to get up to speed on the best advice of dos and don’ts.
The White House should have been transparent early and often about the shortages that were likely to come and what it was doing to address the situation. The first time parents became aware of the crisis was when they were confronted by empty shelves. Panic ensued.
This isn’t rocket science. One of the key COVID lessons is the need for regular and truthful communications with the public. This lesson went unheeded. The White House and the FDA could have stepped up and been seen as both teacher and expert on the job for the public health — an unfortunate missed chance to build trust and credibility.
What about the Defense Production Act? The White House say it’s “considering it,” but that’s a canard. You can’t insist that, say, milk plants begin producing baby formula. It’s not like having General Motors stop making cars and start making tanks.
Another question is why Abbott, no small-potatoes neophyte to FDA manufacturing regulations, allowed such a dismal state of affairs in the first place. Asked year after year to do more with less, it’s not surprising some manufacturers are letting their regulatory standards slide. Proper compliance is expensive. This isn’t an excuse, but it does point to a solution: more regular and robust (and surprise) FDA inspections.
Abbott’s situation was predictable according to the broken-windows theory of regulation. Infrequent oversight initially results in small breaches of good manufacturing practices. They accumulate and bad things happen. Will congressional hearings address this and increase the agency’s inspection budget? The White House should propose these solutions before hearings commence.
But there’s an even bigger issue here. Baby formula is a consolidated industry with only a handful of large players. When one plant goes offline, shortages follow. This is also true on the FDA’s drug and device sides for crucial products such as IV tubing, hospital sterile injectable products and insulin. The FDA must review all such consolidated products and develop a strategy should a major producer become unable to keep its plant open due to “act of God” circumstances such as storms, earthquakes — or acts of terrorism. The agency’s food side could learn a lot from the many steps other FDA centers have made to ensure quality and mitigate shortages.
Not surprisingly, the baby-formula shortage has devolved into a cudgel to beat both the FDA and President Biden. There’s plenty of blame to go around. That’s politics. But this is an opportunity to identify and fix bigger publichealth issues. Shortages happen. Shortages of planning must not.