Contact Your Congressional Office Regarding FDA Guidance on Tissue Availability

January 21, 2025

On January 6, 2025, the FDA released six guidance documents, including two final 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). These documents, issued without public comment, impose a demanding four-week implementation timeline, effective February 3, 2025.

AATB submitted a detailed letter to the FDA on January 15, 2025, outlining concerns about the operational challenges, insufficient clarity, and potential patient access issues stemming from these guidance documents. Read the full letter on the Government Advocacy Correspondences page of the AATB website.

Additionally, AATB, in collaboration with the Association of Organ Procurement Organizations and the Eye Bank Association of America, sent a letter to the Department of Health and Human Services (HHS) transition team for President-elect Trump on January 16, 2025. This joint correspondence calls for the immediate rescission of the Sepsis and Mtb guidance documents and emphasizes the need for public comment and practical timelines. View the joint letter here.

How You Can Help
AATB urges tissue establishments and stakeholders to contact their Congressional offices to support AATB’s request for the guidance documents’ rescission. This will help prevent disruptions in tissue availability and ensure a fair public comment process. If you contact your Congressional office, please copy Andrew Vogt, AATB’s Director of Governmental Affairs, at vogta@aatb.org.

Draft Email for Congressional Offices

Subject: Urgent Request to Rescind Two Recent FDA Mtb and Sepsis Guidance Documents

Dear [Name],

I’m reaching out today with an urgent request to please contact the Department of Health and Human Services or Food and Drug Administration to urge them to rescind or, at a minimum, delay implementation of the two guidance documents released on January 6 that could drastically limit the availability of safe tissue-based products for patients in need. 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 (starting February 3, 2025). President Trump’s January 20 Presidential Action “Regulatory Freeze Pending Review” does not require a 60-day implementation delay but gives the agency the option to do so, which they haven’t done to date. 

The American Association of Tissue Banks, Association of Organ Procurement Organizations, and Eye Bank Association of America wrote with this request to the Department of Health and Human Services transition team for President-elect Trump earlier this month, highlighting some of our key concerns. Had the documents been issued in draft form, many of the issues in the guidance documents could have been avoided. Unfortunately, they were not, so we would appreciate it if you could weigh in with the administration regarding this request.

Thank you for considering, and please let me know if you have any questions.

Sincerely,  
[Your Name]
[Your Title]
[Your Organization]