By Ricardo Carvajal –
In an unusual “Early Alert,” the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) publicly took FDA to task for allegedly lacking “an efficient and effective food recall initiation process that helps ensure the safety of the Nation’s food supply.” The alert describes that finding as preliminary, and as the result of an ongoing audit that is expected to yield a more comprehensive report. Nonetheless, the alert was somewhat startling, and prompted FDA to issue public statements in response (see here and here).
In brief, OIG’s preliminary finding was based on a “judgmental sample” of 30 recalls conducted in a two-and-a-half year period. A footnote in the alert explains OIG’s approach to sampling: “We selected recalls by considering certain risk factors, including but not limited to the recall classification, length of time for the firm to initiate a recall, and length of time for the FDA to classify a recall.” In other words, OIG’s sampling was intentionally biased toward selection of the most complex recall situations – precisely those situations that would be most likely to show apparently inordinate delays. Nowhere does the OIG’s alert acknowledge that underlying complexity, nor does it acknowledge that FDA effectively supervised thousands of recalls during the time frame in question. Instead, the alert implies that FDA may have unnecessarily placed consumers “at risk of illness or death” as the result of the agency’s lack of “policies and procedures that instruct its recall staff to establish set timeframes for (1) FDA to request that firms voluntarily recall their products and (2) firms to initiate voluntary food recalls.”
For its part, FDA states that the delays identified by OIG are “unacceptable,” and expresses appreciation for OIG’s input. However, FDA also provides some of the contextual information lacking in OIG’s alert, and concludes that a one-size-fits-all approach to establishing timeframes and deadlines is the wrong remedy. FDA’s conclusion should be obvious to anyone who has witnessed how a recall decision can hinge on the evaluation of disparate and sometimes conflicting information, which now can include the results product and environmental testing, whole genome sequencing, and epidemiologic investigation. FDA’s conclusion should also be obvious to anyone with a passing familiarity with instances where an outbreak was attributed to the wrong product. As FDA notes, “to request a recall without evidence risks recalling the wrong product and leaving consumers vulnerable to contaminated food that is still on the market.” It also risks wrongly inflicting hefty economic damage that a business might not survive, and for which there may be little chance of recovery from the government.
One can hope that OIG will adopt a more complete and nuanced view of how recalls unfold in the real world before issuing its more comprehensive report, and will understand the need for accuracy as well as speed in evaluating potential recall situations. Even so, FDA’s statements make clear that the agency is pushing to speed up its response to such situations, and industry should take heed.