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Unintended Consequences

Unintended Consequences

A frightening nationwide shortage of baby formula (and enteral nutrition supplies) is creating disruption and anxiety among the many people who rely on these products. On the surface it is another in a series of supply chain issues that seem to be everywhere these days. I see a parallel between baby formula and CPAPs and therein perhaps a different prism through which to view such issues. 

The baby formula shortage originated after the FDA closed an Abbott formula production facility in Michigan. Shuttering of the plant followed an incident where four infants were hospitalized and two of them died after getting a bacterial infection linked to formula produced in the plant. Abbott says that the same bacteria was found at the plant during the subsequent investigation, but not in areas where product is made. Extensive testing was done of finished product and none of it tested positive for said bacteria. 

In 2021 Philips announced a recall of certain CPAP machines based on the potential of negative health consequences associated with degradation of foam in the machines. The FDA drove the recall along with restrictions on Philips for the sale and distribution of new CPAP machines. While there have been complaints of various symptoms, according to Philips there have been no reports of serious harm or reports of death associated with these machine issues. This FDA action is resulting in replacement or refurbishing of CPAP machines and remediation of the potential impact of the degraded foam. Hundreds of thousands of people with sleep apnea are not using CPAP today because of an inadequate supply of CPAP machines in America. 

In both baby formula and CPAPs, the FDA took consequential actions in response to actual and potential heath exposures. Those FDA actions also made significant negative impacts on the supply chain. And the supply chain disruption also has negative health impacts. A classic case of unintended consequences. 

The truth is that our world is highly interconnected. All significant actions have multiple reactions. Some of the reactions are desirable, others are detrimental. It is true in FDA and regulatory matters, it’s also true in decisions we make daily in our businesses, organizations and communities. My take is that closing the Michigan formula plant and halting Philips from providing CPAPs were both bad decisions, all things considered. I accept that my point of view could be wrong. Regardless, it’s a good reminder to us all that as much as we desire simplicity, our big decisions have ripple effects and consequences, and we are all wise to be sure to think through those consequences before we act. 


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