Former HFA Board President Paul Brayshaw recently delivered a statement on behalf of our organization before the Food and Drug Administration’s Blood Product Advisory Committee (BPAC) regarding a proposed change to the policy on blood donations from men who have sexual contact with men. In this statement, Mr. Brayshaw stated that, while we do not support “inherently discriminatory processes,” the FDA must concurrently put into place a strict hemovigilance surveillance program to maintain the safety of the blood supply. For Mr. Brayshaw’s full statement, please keep reading.
My name is Paul Brayshaw and I am here speaking on behalf of the Hemophilia Federation of America, as the former President of the Board. HFA is a nonprofit that assist and advocates for those with bleeding disorders. I would like to thank the committee for the opportunity to provide the patient’s perspective on the proposed revision of the MSM donor deferral policy.
As end users of blood products and plasma protein therapies, it is vital to the health of those with bleeding disorders that all policies concerning the blood supply take patient issues into account first and foremost. That being said, HFA does not support inherently discriminatory policies and feels that there is an opportunity to revise the current deferral policy provided that a robust, comprehensive hemovigilance program is also implemented.
Those with hemophilia experienced first-hand the devastating effects of a tainted blood supply and many remain leery of the ability of those charged with protecting them to do so adequately. In conjunction with our APLUS coalition partners, we would like to stress the critical importance of a robust hemovigilance program as a component of any policy change. Without this system, it will be impossible to track and counter known and emerging infectious threats to the blood supply – whether they arise from a change in the MSM policy or occur more broadly.
In December 2013, and again in November of this year, the ACBTSA recommended the establishment of a Transfusion Transmitted Infections Monitoring Program, or TTI. We fully support this recommendation.
The benefits of a TTI include, but are not limited to:
- The monitoring of modified or new deferral criteria
- The monitoring of the impact of changes to the Donor History Questionnaire
- The monitoring of the impact of new screening strategies
- The comparison of TTI marker rates and risk factors as well as the pre and post-implementation of policy changes
- A scientific foundation for the consideration of any future revisions
In conclusion, we urge HHS to fully fund a robust TTI monitoring program to ensure that the ramifications of all present and future policy changes are tracked and based on sound scientific evidence. And while we support a revision of the current deferral policy for MSM donors, we believe that a comprehensive hemovigilance program must be implemented concurrent with such a change.
