FDA won’t fire anyone over infant formula fiasco, chief says
The Food and Drug Administration (FDA) will undergo an overhaul in the wake of the nation’s formula shortage, but no one at the agency will be reassigned or fired, Commissioner Robert Califf said Tuesday.
Califf announced a “transformative new vision” for the agency that will bring together regulators responsible for food safety under a new “Human Foods Program”. However, this general restructuring of agency components of the FDA has not been accompanied by a specific plan to address issues identified by an internal FDA review that have hampered its response to the infant formula shortage. Additionally, when asked at a press conference, the commissioner said there were no plans to fire or reassign anyone involved in the agency’s failures.
Califf acknowledged there had been “changes in direction” – the FDA’s top food safety official, Frank Yiannas, resigned last week. In his resignation letter, Yiannas wrote that the structure of the food program “has significantly impeded the FDA’s ability to operate as an integrated food team and protect the public.”
“But the short answer is no one will be reassigned or fired because of the infant formula situation,” Califf told reporters, according to Politico.
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The FDA was widely criticized by lawmakers last year for its belated response to formula shortages and its handling of a bacterial outbreak at an Abbott Nutrition production facility in Michigan.
Abbott’s factory was shut down after the Cronobacter pathogen was detected in its formula and led to at least four childhood illnesses, including two deaths. Abbott has denied a causal relationship between its products and the diseases, but the company is now under criminal investigation by the Justice Department, The Wall Street Journal reported.
A whistleblower had tried to notify the FDA about problems at Abbott’s facilities in the fall of 2021, but government inspectors didn’t investigate the complaints until months later.
An internal review found that “inadequate processes and a lack of clarity” related to whistleblower complaints may have delayed the agency’s response, along with outdated technology.
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The report says FDA’s emergency response lacks clarity on the roles between programmatic and incident command standard operating procedures; the agency needed effective mechanisms to quickly engage with regulatory and public health partners to avoid confusion; its investigators have received limited training specific to infant formula; funding limitations had stalled the food program’s growth; record keeping practices were outdated and the FDA lacked the capacity to manage supply chain issues.
Califf told Congress that the FDA’s response was “too slow and there were suboptimal decisions along the way.” However, he blamed “mailroom problems” caused by the pandemic for the agency’s failure to respond to complaints from whistleblowers.
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The FDA chief’s reforms will generally address these and other issues raised by an external evaluation led by the Reagan-Udall Foundation by consolidating the FDA’s Center for Food Safety and Applied Nutrition, Office of Food Policy and response, and components of the Office of Regulatory Affairs. in a unified human food program. A new Deputy Commissioner for Human Foods will be hired to oversee the program and will report directly to the FDA Commissioner.
“The Deputy Commissioner will have decision-making authority over policy, strategic and regulatory program activities within the Human Food Program, as well as resource allocation and risk prioritization,” Califf said.
Additionally, the FDA will establish a Human Foods Advisory Committee comprised of outside experts to “advise on challenging and emerging issues in food safety, nutrition, and innovative food technologies.”
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“Creating a human food program under a single manager who reports directly to the commissioner unifies and elevates the program while removing redundancies, allowing the agency to oversee human food more effectively. and efficient,” Califf said.
Fox News’ Julia Musto contributed to this report.