EBAA submitted comments to FDA last week on recent guidances that address HCT/P donor eligibility and recommendations to reduce the risk of HIV, hepatitis B virus and hepatitis C virus transmission by HCT/Ps.
The comments support FDA’s commitment to evolving policies that result in new, evidence-based recommendations using the same risk-based donor eligibility questions for all HCT/P donors and removing unnecessary time-based deferrals.
The HIV, HCV, and HBV comments request clarification as to the definition of a “new sexual partner” and the risk assessment for a secondary sexual partner. As written, the recommendations result in an inconsistent eligibility determination of certain donors based on sexual contact with individuals who are themselves eligible to donate.
We have asked FDA to consider discontinuation of the HBsAg testing requirement and shared data on the alarming increase in ocular donors with positive HBsAg test results and negative HBV NAT results.
The comments also request an extended implementation period of at least 6 months to allow facilities to focus on successful implementation of these complex changes.
These comments are available below:
Contact Jennifer DeMatteo with any questions.
