Wednesday’s House vote of contempt for the head of the Food and Drug Administration was a result of months of delays in investigating the problems at the nation’s largest baby formula plant, which led to an ongoing shortage.
Robert Califf, FDA Commissioner, outlined a series setbacks in congressional testimony which slowed his agency’s response. These included a COVID-19 epidemic at the plant and an FDA whistleblower complaint that was lost in the mail.
Califf gave evidence before a House subcommittee that was investigating the shortage. This has turned into a national political controversy, and the U.S. military had to start airlifting supplies from Europe.
The main cause of the shortage is Abbott’s Michigan plant. This facility was closed by FDA in February because of contamination. Califf, who was under fire from Congress, parents, and the media, gave Wednesday’s first detailed account of how his agency spent months inspecting and closing the plant, despite discovering potential problems in September.
Califf stated that the FDA responded by saying, “Too slow and there was a lot of suboptimal decisions along the way.”
The FDA and President Joe Biden are under increasing pressure from the political world to explain why they did not intervene earlier to stop the supply crisis.
“Why did it take an inundation of national media attention for Biden’s administration to act with the urgency required to address a shortage of infant formula?” asked Rep. Morgan Griffith (R-Virginia), the ranking Republican on the committee.
Califf stated that the agency tried to monitor formula supply since 2020, when COVID-related disruptions were first discovered. However, regulators only have limited visibility into companies’ supply chains.
Three formula manufacturers were also represented by the House panel, including an Abbott Nutrition executive who apologized for the shortage to parents.
“We let you down,” stated Christopher Calamari, vice president of Abbott. “We are deeply sorry.”
Calamari repeatedly dodged questions about whether employees were fired or disciplined for the problems at the plant. These included standing water and a leaky roof.
The FDA began monitoring Abbott’s plant last autumn and tracking multiple bacterial infections among infants who had received formula from the facility. Four cases were reported between September and January and resulted in hospitalizations and two deaths.
According to Califf’s testimony, the FDA intended to start inspecting the Sturgis plant in Michigan on December 30. Abbott rebutted that approximately 12 employees of the plant had tested positive to COVID-19, and asked for a delay. The FDA did not begin inspections until January 31.
After testing positive for a rare but dangerous bacteria in several parts of the plant’s structure, the FDA shut down the facility. Abbott announced that a massive recall was being made of its formula on February 17.
Califf said that while we knew that stopping plant operations would cause supply problems, it was impossible to avoid the insanitary conditions.
