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Wednesday, June 29, 2022

FDA chief fires for slow response to baby formula issue

WASHINGTON — The head of the Food and Drug Administration faced bipartisan fury from House lawmakers on Wednesday over months delaying an investigation into problems at the nation’s largest baby formula plant that prompted ongoing shortages.

FDA Commissioner Robert Califf struck a number of setbacks in congressional testimony that slowed his agency’s response, including a COVID-19 outbreak at the plant and a whistleblower complaint that did not reach FDA leadership because it Was apparently lost in the mail.

Calif testified before a House subcommittee investigating the shortage, which snowballed into a major political controversy and forced the US to begin airlifting products from Europe.

The FDA’s response was: “Very slow and there were decisions that were suboptimal along the way,” Calif told lawmakers.

The FDA and President Joe Biden face mounting political pressure to explain why they didn’t intervene earlier to tackle the supply crisis.

“Why did it receive national media attention for the Biden administration to act with the sense of urgency needed to address an infant formula shortage?” Representative Morgan Griffith, R-Virginia, asked the ranking Republicans on the committee. The panel is also going to hear from three formula manufacturers, including Abbott Nutrition.

The shortage comes mostly from Abbott’s Michigan plant, which the FDA closed in February due to contamination issues. Calif gave the first detailed explanation of why his agency took months to inspect and shut down the plant, despite learning of potential problems in early September.

“We knew that shutting down plant operations would cause supply problems, but we had no choice given the unhygienic conditions,” Calif said in preliminary testimony.

FDA staff began honing in at Abbott’s plant last fall while tracking multiple bacterial infections in babies who ingested formula from the facility. Four cases occurred between September and January, leading to hospitalizations and two deaths.

According to California testimony, the FDA plans to begin inspections of the Sturgis, Michigan, plant on December 30. But Abbott warned that about a dozen of its employees had tested positive for COVID-19 and requested a delay. As a result, the FDA did not begin its inspection until January 31.

World Nation News Desk
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