FDA needs to modernize for future crises

The Food and Drug Administration on Tuesday acknowledged that it was poorly equipped to handle the baby formula crisis that erupted in the spring, lacking sufficient technology, personnel and authority to address the situation.

Why it matters: Several babies died of suspected Cronobacter bacterial contamination, triggering a massive recall of Abbott Nutrition formula and widespread shortages of formula that sent parents scrambling to meet their babies’ nutritional needs.

  • While Abbott came under fire for conditions at its factory in Sturgis, Michigan, the FDA also faced scrutiny for failing to act quickly to prevent the crisis from getting out of control.

What they’re saying: Abbott said in a statement that “we meet and exceed regulatory requirements for infant formula testing” and maintain “a zero-tolerance policy for Cronobacter,” testing regularly for it and eliminating it “if/when we find it.”

Driving the news: The FDA released a report documenting its handling of the crisis, saying that it lacked the wherewithal and know-how to take effective action.

  • “Simply put, if the FDA is expected to do more, it needs more,” the report’s author, Center for Veterinary Medicine director Steven Solomon, said in a note accompanying the document.

What they found: The crisis exposed a variety of shortcomings at the FDA, Solomon noted in the report, including:

  • “Outdated” systems with a “lack of coordination” tracking product problems, making it difficult to “rapidly identify emerging safety and quality issues.”
  • Whistleblower complaints were “not delivered” to their addressees due to “inadequate processes and lack of clarity” on how to handle them.
  • “Limited infant formula-specific training” for FDA investigators.
  • A lack of authority to address shortages of critical food products.
  • “Scientific gaps in understanding Cronobacter contamination and illness hindered the FDA’s response throughout the incident.”

Yes, but: The agency faulted Abbott for triggering the crisis, saying conditions at the company’s plant in Sturgis, Michigan, “were not consistent with a strong food safety culture.”

  • Yet “the FDA does not have the authority to require manufacturers of infant formulas or certain medical foods to notify it when they become aware of a circumstance that could lead to a shortage of these products for U.S. consumers, or to require manufacturers to put in place risk management plans,” Solomon noted.

The other side: Abbott Nutrition executive Christopher Calamari told families in prepared congressional testimony in May that “we let you down” and “we are deeply sorry and are committed to making sure that a shortage like this never happens again.”

  • But he also reiterated that “we continue to believe that there is no conclusive evidence to link our formulas” to infant illnesses and deaths blamed on Cronobacter.

Worth noting: The report did not seek to address whether industry consolidation — four companies control about 87% of the market — or other factors outside of its control contributed to the crisis.

  • The Federal Trade Commission has launched a probe into reports that baby formula sellers engaged in deceptive practices, price gouging or other illegal tactics.

Editor’s note: This article has been updated with comment from Abbott.