FDA needs to modernize for future crises

The Food and Drug Administration on Tuesday acknowledged it was ill-equipped to deal with the baby food crisis that erupted in the spring, and lacked the technology, manpower and authority to address the situation.

Why it matters: Several babies died from suspected Cronobacter bacterial contamination, leading to a massive recall of Abbott Nutrition’s formula and a widespread shortage of formulas, prompting parents to scramble to meet their babies’ nutritional needs.

  • While Abbott came under fire over conditions at its Sturgis, Michigan factory, the FDA also faced scrutiny for failing to act quickly to prevent the crisis from spiraling out of control.
  • Abbott did not immediately respond to Axios’ request for comment.

Driving the news: The FDA released a report documenting its handling of the crisis and said it lacked the resources and expertise to take effective action.

  • “Put simply, 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.
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What they found: The crisis has exposed a variety of shortcomings at the FDA, Solomon noted in the report, including:

  • “Outdated” systems with “lack of coordination” for tracking product issues, making it difficult to “quickly identify emerging safety and quality issues.”
  • Whistleblower complaints were “not served” on their addressees because there were “inadequate processes and ambiguities” about how to deal with them.
  • “Limited Infant Formula Specific Training” for FDA investigators.
  • A lack of powers to address shortages of critical food products.
  • “Scientific gaps in understanding Cronobacter contamination and disease hampered FDA response throughout the incident.”
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Yes but: The agency blamed Abbott for creating the crisis, saying conditions at the company’s Sturgis, Michigan plant were “inconsistent with a strong culture of food safety.”

  • However, “The FDA does not have the authority to require or require manufacturers of infant formula or certain medical food products to notify them if they become aware of a circumstance that could result in a shortage of those products for US consumers to put those risk management plans in place,” Solomon noted.

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

  • But he also reiterated that “we continue to believe there is no conclusive evidence to link our formulas to infant diseases and deaths” attributed to Cronobacter.
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Worthless: The report did not attempt to address whether industry consolidation — four companies control about 87% of the market — or other factors beyond its control contributed to the crisis.

  • The Federal Trade Commission has opened an investigation into reports that infant formula sellers have engaged in fraudulent practices, price gouging, or other illegal tactics.

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