FDA releases internal report on its response to the infant formula crisis


The Food and Drug Administration’s internal report provides a comprehensive look at how much work the FDA and Congress have to do to get the agency’s troubled food program back on track. The report focuses on the crisis that led to parents scouring supermarket shelves for infant formula and specialty foods during the spring and summer, but goes much deeper and sheds a self-critical light on the many issues that have plagued the agency from updating outdated technology have to recruit and train qualified employees. The report provides 15 wide-ranging recommendations to improve the agency’s work and addresses existing agencies and resources the FDA will need from Congress to enable real reform.

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The basic conclusion of the report is: “[t]Here there is no single action to explain the events that occurred, rather the report identifies a confluence of systemic vulnerabilities.” While this conclusion is undoubtedly correct, the report is so thin on detail that it is difficult to make sense of what actually happened. For example, the report concludes that “[c]Conditions observed at the Abbott Nutrition facility were not consistent with a strong food safety culture,” but does not provide details, although some descriptions of the conditions at the facility have appeared in press coverage. Similarly, the report mentions that “[a] Complaint sent by mail and other delivery systems from a confidential informant to agency officials on FDA’s White Oak campus was not served on addressees,” but does not make clear what the basis for the complaint was or to whom the notice was addressed was why the communication was not forwarded or whether remedial action was taken.

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Even without clearly stating the actual basis of the deficiency, the report suggests that the FDA made a sincere attempt to learn from these events and identifies a number of practical remedial actions to prevent a recurrence. Many of these recommendations will take years to implement, but this is a solid start. These include, first and foremost, resources for a dedicated Food Safety Authority staff to oversee the infant and specialty foods supply chain and — although the report takes a light-hearted approach here — the power to require manufacturers to notify the FDA of circumstances leading to a shortage could lead. Congress should take these calls seriously, including by submitting a pending User Fee Reauthorization Bill to the agency, which could give the FDA additional tools to identify and address potential formulation bottlenecks.

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Peter G. Lurie, MD, MPH, was the FDA’s Deputy Commissioner for Public Health Strategy and Analysis from 2014 to 2017, where his responsibilities included overseeing the agency’s response to drug shortages.



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