House Oversight and Accountability Committee Chair James Comer (R-KY) and Health Care and Financial Services Subcommittee Chair Lisa McClain (R-MI) are calling for the FDA to provide documents and communications between the FDA, Department of Health and Human Services, and White House staff related to the response to the formula shortage to the committee by April 4.
The Republicans in their letter explained:
The Reagan-Udall Foundation\u2019s report titled \u201cOperational Evaluation of the FDA Human Foods Program,\u201d found that there was \u201clittle motivation, and no requirement,\u201d to \u201cfacilitate critical thinking and proactive decision-making\u201d during the infant formula shortage. Despite this report, and the acknowledged need for a major overhaul, you stated that there would be no reassignments nor firings over the administration\u2019s response to the infant formula shortage.
Formula shortages began in the summer of 2021 as global supply chains were disrupted by the COVID-19 pandemic. As the administration scrambled to contain the issue, families across the nation were presented with the question of how they would feed the infants in their families and communities. Now, instead of removing or reassigning the individuals at fault for the poor response to this crisis, the announced restructuring of the food and nutrition division simply requires certain offices and personnel to report to the newly created position of Deputy Commissioner for Human Foods. The Committee is concerned that the FDA\u2019s restructuring is a superficial attempt\u2014rather than a real effort\u2014to bring accountability and make meaningful changes. [Emphasis added.]
Baby formula shortages began during the first half of the coronavirus pandemic and further progressed in the summer of 2021 when the global supply chains were disrupted further by the pandemic.
Then, in February 2022, Abbott Laboratories shut down the company\u2019s largest formula factory, which produces roughly one-fifth of U.S. formula, because of safety concerns, in addition to recalling various infant formulas from the plant. This inevitably triggered empty store shelves, higher prices, and retailers limiting sales of scarce products. As of May 2022, a study found that 43 percent of formula products are still out of stock nationwide.
The press release accompanying the letter also acknowledged that, at the time, former President Donald Trump\u2019s HHS Secretary, Xavier Becerra, had plenty of notice of the shortage unfolding but that the FDA delayed taking the steps it needed to have done in order to address the crisis.
The committee has also scheduled a hearing next week on the issue, according to the Wall Street Journal, including testimony from Frank Yiannas. This former FDA official was involved with the formula recall.<\/p>\n\n\n\n