Presenting testimony to the House Committee on Oversight and Accountability Subcommittee on Healthcare and Financial Services on March 28th, Frank Yiannas former Deputy Commissioner of the Food and Drug Administration cast doubt on the FDA “national strategy to ensure the safe and adequate supply of baby formula”.
Yiannas noted the “silo mentality” that existed in the FDA during early 2022 responsible for delay in action to avert the crisis in the supply of infant formula. He characterized the FDA plan to respond to a future crisis as “well intentioned”, but he observed that it was a vision and would depend on reorganization of the structure of the Agency yet to be implemented.
Yiannas noted that Cronobacter sakazakii that was present in the Abbott plant in Sturgis, MI. has also been isolated from other production facilities producing infant formula. Yiannas pointed to the age and lack of maintenance of equipment at the Sturgis facility noting, “We should no longer be producing food for infants using equipment that is showing its age and increasing the risk of potential problems.”
He concluded his testimony by stating, “In other words the nation remains one outbreak, tornado, flood or cyber attack away from finding itself in a similar place to that of February 17, 2022.” He maintains that the U.S. supply of infant formula is still vulnerable to safety concerns and could in the future be disrupted. He opined, “It is my view that the state of the infant formula industry today is not much different than it was in February 2022 when the recall by the FDA was announced and the plant was closed.”
The comments by Yiannas confirm the culture prevailing at the FDA that withheld the whistleblower report from the Deputy Commissioner who in any event had no executive authority. The Agency failed to act on the allegations for months. The FDA excuse that the delay was attributed to the “mailroom” is disingenuous given that copies of the report were hand- delivered by courier mail to responsible managers at FDA who took no action.
Testimony presented at this and similar hearings confirm that the FDA is failing in its responsibility to consumers. The inappropriate reorganization plan suggested by the Commissioner Dr. Robert Califf is indicative of the depth of problems at the FDA. Separation of food-related responsibilities from the FDA and the establishment of a Food Safety Agency is indicated by the frequency and severity of foodborne outbreaks, lack of proactive planning and demonstrated institutional incompetence.