AATB Urges FDA Commissioner to Rescind Sepsis and Mtb Guidance Documents

As part of our continued advocacy efforts, AATB—alongside AOPO and EBAA—sent a joint letter today to newly confirmed FDA Commissioner Dr. Marty Makary urging the immediate rescission of two guidance documents issued as final on January 6, 2025:

• Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by HCT/Ps
• Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by HCT/Ps

While the FDA previously extended the implementation deadline from February 3 to May 4, 2025, our significant concerns remain unaddressed. These guidance documents, as written, introduce unclear directives, impractical expectations, and severe operational challenges that jeopardize the availability of safe, life-transformative musculoskeletal and ocular tissue products.

Today’s letter reiterates our call for the FDA to rescind or further delay implementation until the concerns raised by AATB and our partner organizations are fully considered and addressed. You can read the full letter and find all related advocacy communications on the Government Advocacy Correspondences page of the AATB website.