Abbott has announced that it has agreed to to a consent decree under which it would be allowed to reopen its Michigan baby formula plant if all goes according to plan. Former FDA Associate Commissioner Peter Pitts supports the propriety of the FDA’s actions in the Abbott case. He sets forth his views in a New York Post column here. Mr. Pitts is the president of the Center for Medicine in the Public Interest, a think tank founded by our friends at the Pacific Research Institute. He states in conclusory fashion that the FDA did the right regulatory thing. I take it that he relies on the “operational deficiencies” to which reference is made by the FDA in its current press release (quoted below).
In the complaint, filed by the U.S. Department of Justice on behalf of the FDA, the government alleges that powdered infant formula products manufactured at Abbott Nutrition’s Sturgis facility were adulterated because they were made under insanitary conditions and in violation of current good manufacturing practice requirements. On Jan. 31, the FDA commenced a for-cause inspection and identified Cronobacter sakazakii, a bacterium that can potentially cause severe foodborne illness primarily in infants, in the facility and observed significant operational deficiencies. While the agency’s inspection was ongoing, Abbott Nutrition voluntarily recalled certain powdered infant formula products and voluntarily shut down its facility to implement corrective actions that address issues raised by the FDA.
Abbott has posted its own press release that setting forth “Detailed Findings of Investigation.” One gets the impression from Abbott that the FDA has unnecessarily created a third-world crisis. The Abbott press release states that, after a thorough investigation by the FDA, the CDC, and Abbott, and review of all available data, there is no “conclusive evidence” to link Abbott’s formulas to what the four serious cases of bacterial infection that led to the February shutdown. The press release omits any of the evidence that might support the FDA’s action. Consistent with Pitts’s column, one can infer that such evidence exists and conclude that it makes sense to err on the side of safety if relevant evidence raised serious concerns.
Abbott’s press release nevertheless sets forth an interesting collection of bullet points. According to Abbott:
• CDC concluded its investigation with no findings of a link between Abbott formulas and infant illnesses.
• Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakiior Salmonella.
• All retained product tested by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter sakazakii and/or Salmonella. No Salmonella was found at the Sturgis facility.
• The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the facility and has not been linked to any known infant illness.
• Genetic sequencing on the two available samples from ill infants did not match the strains of Cronobacter sakazakii found in Abbott’s plant. Samples from ill infants did not match each other, which means there was no connection between the two cases.
• In all four cases, the state, FDA and/or CDC tested samples of the Abbott formula that was used by the child. In all four cases, all unopened containers tested negative.
• Open containers from the homes of the infants were also tested in three of the four cases; two of the three tested negative. The one positive was from an open container from the home of the infant, and it tested positive for two different strains of Cronobacter sakazakii, one of which matched the strain that caused the infant’s infection, and the other matched a strain found on a bottle of distilled water in the home used to mix the formula. Again, neither strain matched strains found in Abbott’s plant.
• The infants consumed four different types of Abbott formula made over the course of nearly a year and the illnesses took place over several months in three different states.
Following the last bullet point the Abbott press release adds this explanation:
Cronobacter sakazakii is naturally occurring and found nearly everywhere in the environment. Powdered infant formula manufacturers periodically detect it in their plants, and FDA, in issuing its infant formula Current Good Manufacturing Practices (cGMP) regulations, stated that, based on current technologies, it is not possible to produce a sterile powdered infant formula (79 Fed. Reg. 7987). However, Abbott has no tolerance for Cronobacter sakazakii in its production environment, and no Abbott product was distributed with Cronobacter sakazakii contamination.
One more point. In addition to Peter Pitts’s New York Post column linked above, a Post editorial takes up the predictable shortages that have ensued as a result of the Abbott plant shutdown. The Post editorial is “Go Rep. Stefanik: Biden owns our baby formula mess.”