AATB Leads Effort to Address FDA Mtb and Sepsis Final Guidance Documents with Trump Administration HHS Transition Team

January 16, 2025

AATB has led the drafting of a letter to the Department of Health and Human Services Transition Team for President-elect Donald Trump, joined by AOPO and EBAA, to urge the immediate rescission of two FDA guidance documents released on January 7, 2025. These documents, Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by HCT/Ps (Sepsis guidance) and Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by HCT/Ps (Mtb guidance), were issued without public comment and impose an impractical four-week implementation timeline.

The letter outlines significant concerns, including operational challenges, unclear directives, and the potential reduction of the availability of musculoskeletal and ocular tissue products.

Read the full letter here