The US FDA Develops Strategy to Prevent Infant Formula Shortages

Congressional Subcommittee Hearing on the Infant Formula Crisis of 2022

The US Congress has recently convened a subcommittee hearing on the infant formula crisis of 2022. Witnesses included Frank Yiannas, former FDA Deputy Commissioner, and Peter Lurie, President and Executive Director for the Center for Science in the Public Interest. During the hearing, Yiannas spoke about the factors that led to the previous shortage of infant formula and pointed out the ineffective management from the top that continues to plague the agency. He praised Congress for holding the hearing and urged lawmakers to heighten regulations on manufacturers and enhance organization within the FDA to prevent another shortage.

Criticism of FDA Commissioner Robert Califf

Committee Chair Lisa McClain criticized FDA Commissioner Robert Califf for failing to send a whistleblower report about the infant formula crisis to appropriate officials in a timely manner. Members of the committee put blame for the crisis on Abbott Nutrition but also asked pointed questions about how the situation could have been better handled by the Food and Drug Administration. Problems at the FDA included a fractured chain of command, internal mailroom problems, and silos without effective communication or coordinated efforts.

US FDA Releases Strategy to Ensure Safe and Resilient Infant Formula Market and Supply

In response to this crisis, the US FDA has released a strategy aimed at increasing the resiliency of the infant formula market and supply in America while ensuring that it is safe and nutritious. The goal is to mitigate future supply disruptions with key elements including developing redundancy risk management plans and enhancing inspections of manufacturers. There will also be an expedited review process for premarket submissions of new infant formula products aimed at preventing shortages in future.

Warning About Another Infant Formula Shortage

Frank Yiannas warns lawmakers about another possible infant formula shortage. The factors that led up to the previous shortage are still “elusive,” and the infant formula industry still lacks “resiliency.” Yiannas calls for heightened regulations on manufacturers and greater organization within the FDA to prevent another shortage. He presents a dozen recommendations to prevent future shortages, including making Cronobacter sakazakii bacterial infections a nationally notifiable disease.

Porter Notes Monopolistic Nature of the Industry

Porter notes the monopolistic nature of the infant formula industry in which four companies control 90% of the US market. This concentration creates problems with supply chain management due to a lack of competition. According to Porter, this puts consumers at risk and makes it difficult for them to access other brands that are not part of government programs.

Long-term National Strategy

The US FDA is also developing a long-term national strategy to improve preparedness against infant formula shortages. This strategy aims to improve information-sharing, recommend measures for protecting the integrity of the infant formula supply chain, and preventing contamination. The agency will work closely with government partners to sustain safe, continuous production of infant formula while improving consumer education materials on FDA.gov. They will also engage with healthcare providers and professionals to expand their consumer education program.

In conclusion, the US FDA is taking steps toward ensuring a safe and resilient infant formula market and supply in America. While concerns about possible future shortages continue, lawmakers and industry experts alike are working together to prevent such an event from occurring again. By implementing new regulations on manufacturers, enhancing organization at the FDA, and expanding consumer education efforts, these stakeholders are working toward a stronger and more stable infant formula market in America.

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