AATB Commends Representatives Dingell and McCormick for Urging FDA to Reconsider Sepsis Screening Policy

AATB commends Representatives Debbie Dingell (D-MI) and Rich McCormick, MD (R-GA) for writing to Acting FDA Commissioner Kyle Diamantas regarding the agency’s policy on screening human tissue donors for sepsis. The bipartisan letter encourages the Food and Drug Administration (FDA) to consider screening for systemic infection, rather than relying on sepsis diagnosis, prior to finalizing the draft guidance document “Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).”

Over the past two years, AATB has actively engaged extensively with FDA and policymakers on this issue through advocacy, research, and stakeholder outreach efforts, including:

• Publishing the initial AATB Physicians Council Sepsis Working Group Sepsis Pilot Study Report in September 2024, based on the review of 486 de-identified donor records across seven tissue establishments
• Requesting in January 2025 that the HHS Trump Transition Team rescind the sepsis guidance document issued as final for immediate implementation on January 6, 2025
• Requesting in April 2025 that FDA rescind that same sepsis guidance document 
• Releasing an updated Sepsis Pilot Study Report in December 2025 using standardized statistical methods to provide additional clarity and rigor to the study findings
• Submitting comments to FDA in July 2025 regarding the agency’s draft sepsis guidance document
• Sending a December 2025 letter to FDA regarding sepsis-related FDA 483 observations issued to an AATB-accredited tissue establishment
• Meeting with lawmakers and congressional staff during AATB’s 2026 Capitol Hill fly-in to advocate for improvements to FDA’s approach to sepsis screening
• Submitting comments to FDA in March 2026 urging the agency to rescind the classification of sepsis as a relevant communicable disease agent or disease (RCDAD) in the 2007 donor eligibility guidance

AATB appreciates Representatives Dingell and McCormick for their leadership on this important issue and looks forward to continued collaboration with Congress, FDA, and stakeholders to support policies that protect patient safety while preserving access to safe life-enhancing tissue allografts.

The full text of the congressional letter can be found here.