Comer & McClain Press FDA on Infant Formula Crisis Response

Renew request for communications between FDA, HHS, and White House staff

WASHINGTON—House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) and Subcommittee on Health Care and Financial Services Chairwoman Lisa McClain (R-Mich.) are calling on the U.S. Food and Drug Administration (FDA) to provide documents and communications related to the FDA’s response to the United States’ infant formula crisis, reiterating serious concerns over the Biden Administration’s failure to respond to the nationwide shortage.

“The Committee on Oversight and Accountability is continuing its investigation into the U.S. Food and Drug Administration’s (FDA) response to the infant formula shortage and its restructuring of the food and nutrition division in response to the infant formula shortage. The Reagan-Udall Foundation’s report titled ‘Operational Evaluation of the FDA Human Foods Program,’found that there was ‘little motivation, and no requirement,’ to ‘facilitate critical thinking and proactive decision-making’ 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’s response to the infant formula shortage. We request documents and communications to understand the FDA’s response to the infant formula shortage,” wrote the lawmakers.

Last year, nearly 43 percent of infant formula was out of stock in stores across the country, leaving American parents and caregivers struggling to keep their children fed. Department of Health and Human Services Secretary Xavier Becerra had ample notice of the unfolding crisis, yet the FDA delayed taking steps to address the crisis and reopen a critical U.S. manufacturing facility. In multiple letters last Congress, Chairman Comer requested information from former White House Chief of Staff Ron Klain to understand what the Biden Administration knew and what actions were being taken to alleviate the burden on parents.

“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’s restructuring is a superficial attempt—rather than a real effort—to bring accountability and make meaningful changes,” continued the lawmakers.

The letter to FDA Commissioner Robert Califf can be found here.