McClain Requests Transcribed Interviews from FDA Officials Related to Infant Formula Shortage

WASHINGTON—Subcommittee on Health Care and Financial Services Chairwoman Lisa McClain (R-Mich.) today is calling on the U.S. Food and Drug Administration (FDA) to make officials who have information relevant to the 2022 infant formula shortage available for transcribed interviews.

“The more the Oversight Committee uncovers in our investigation into internal failures at the FDA which led our nation into an infant formula crisis, the more questions we have for the FDA. Multiple former FDA officials have now come before our committee and testified that the infant formula crisis was exacerbated by dysfunction and slow responsiveness by the FDA. We believe where there is smoke, there is fire. We need to hear from more officials directly involved at the FDA about the lack of structures in place to prevent a crisis like this, and about actions that have or have not been taken to prevent a similar crisis from happening again. We are going to ensure agencies are held accountable and find solutions to better protect American families in the future,” said Chairwoman McClain.

Background:

• The FDA has consistently delayed in providing responsive documents to the Oversight Committee. The FDA only made former food safety director Dr. Mayne available for testimony at a public hearing after the committee requested her appearance for a transcribed interview.
• The FDA’s dysfunction and delay worsened the formula crisis. FDA officials have stated that the agency’s budget and resources prioritize the drug program over the food program.
• Affiliated parties at the FDA have still not been held accountable. Instead of removing or reassigning the individuals at fault for the poor response to this crisis, the FDA simply announced restructuring of the food and nutrition division.
• The FDA has failed to conduct an independent, objective review of the crisis. Former FDA officials have testified before the Subcommittee that then acting Commissioner Janet Woodcock ghost authored the crisis report.

Subcommittee Chairwoman McClain requests transcribed interviews with the following officials at the FDA:

• Ms. Elizabeth Mayer, National Expert
• Mr. Daniel Arrecis, Investigator
• Mr. William Weissinger, Division Director, OHAF-East Division 6, Office of Regulatory Affairs
• Mr. Lionel Carter, Director, Office of Security and Emergency Management
• Mr. Justin Green, Assistant Commissioner for Criminal Investigations, Office of Regulatory Affairs
• Dr. Andrea Lotze, Medical Director, Infant Formula and Medical Foods, Center for Food Safety and Applied Nutrition
• Dr. Judith McMeekin, Associate Commissioner for Regulatory Affairs
• Mr. Michael Rogers, Assistant Commissioner of Human and Animal Food Operations, Office of Regulatory Affairs

Related:

Hearing Wrap Up: FDA’s Food Safety Director Acknowledges ‘Less Than Ideal’ Slow Response to Formula CrisisHearing Wrap Up: Former FDA Official: Infant Formula Crisis Was “A Preventable Tragedy”