Should the FDA have done more months ago about an impending baby formula shortage?
Steve Kelman asks whether any well-placed Food and Drug Administration officials could have anticipated the current baby formula shortage.
Blog readers will know I am the opposite of a fed basher. I start with the assumption that civil servants are conscientious and dutiful, though of course I accept that in a specific case it can be proven otherwise.
I am asking myself whether the infant formula shortage is an example of "proven otherwise."
Abbott Labs produces 48% of the infant formula sold in the US, of which about half is produced at their Sturgis, Michigan facility. As has been widely reported in the media, in February Food and Drug Administration inspectors investigated complaints and reports of several infants becoming severely ill after drinking infant formula from the facility. After the inspections, Abbott closed the facility. Several months later, with the loss of the Michigan plant supply, significant formula shortages were reported and became a big news story.
I am assuming—though I don't know for sure—that there was at least one person among those working for the FDA on infant formula (I believe they have nine employees working on infant formula in total) who knew, because their job was to monitor the industry, that the Michigan facility was the source of almost a quarter of U.S. formula supply.
So one would have wished to see this employee realize that it was only a matter of time till the shutdown would create a supply problem. Doing that wouldn't have required any extra work or investigation, just a bit of forethought. And one would have liked it if that employee then asked the follow-up question, "What should the FDA do now to avoid this problem in a few months?" The employee might have known an answer to that question just based on their existing knowledge—it turns out that the U.S. already imports formula from an Abbott facility in Ireland, and that Chile, Mexico and the Netherlands have infant formula production capacity that could supply the U.S. market.
The next step would probably have been beyond the scope of the employee's job—actually requesting an assignment to figure out how to get more supply from foreign manufacturers or, more likely, working to get this assignment passed to a more appropriate person.
Apparently, none of this happened. Nobody at the FDA sounded an alarm that in a few months the country would have a predictable crisis on its hand.
I hope blog readers, including those who are feds themselves, will agree that some folks at FDA failed to take some simple steps that could have averted this crisis.
As a non-basher, I think it is appropriate to blame whoever did this. It would appear that they had such a narrow idea of their job responsibilities that if their job description didn't explicitly say "report supply disruptions that can affect product availability," they felt no responsibility to do so. (If this was somehow in their job description, it's even worse of course.)
The larger problem this raises is the extent to which federal employees will not take modest steps to go beyond their job descriptions to serve the public. I of course hope that the kind of behavior we saw here would be very unusual, but the problem here occurred in an agency with a strong public health mission, and I fear this would occur more often than we would wish.
This incident should lead feds to look inward and honestly ask themselves what they would do – and how we can do better.