The Food and Drug Administration’s (FDA) long awaited final guidance “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products” was issued in December. The permanent deferral of men who have a history of sex with other men since 1977 (MSM) has been eliminated and otherwise qualified donors with a history of MSM who have had no such sexual contact in the last 12 months are eligible to donate blood. What may appear to be a straightforward decision to implement revised donation procedures to accommodate the guidance is complicated by recovered plasma (RP).
The amazing work done in community blood centers is viewed as critical for supporting patients on a local and national level with blood components. But, this narrow focus can overlook the important contribution our donors make in supporting patients worldwide when their plasma is shipped to fractionators as RP for further manufacture into therapeutic products.Â
Life changing therapies such as Intravenous Immunoglobulin (IVIG) are derived from RP. The companies that manufacture these medicines are global, distributing products all over the world. A majority of countries in the European Union (EU) retain a lifetime MSM deferral, and other countries enforce deferrals longer than one year. Because of the variability in regulations, fractionator specifications often require adherence to the most stringent regulations. This means many of the fractionators to which blood centers provide RP will maintain longer deferral policies and may not accept our RP. As centers consider the new guidance, they must understand its acceptability to their fractionator.Â
Whether or not blood centers can apply the new deferral criteria to RP will depend on their contracted fractionator. At a minimum, most RP specifications require formal notification to the fractionator for changes like revisions to the donor history questionnaire. For centers contracted with a fractionator who cannot accept RP collected from newly eligible MSM donors because of global regulatory requirements, it is still possible to implement the new deferral criteria. This will require a process to segregate plasma from MSM donors and exclude it from RP shipments. This requires an additional donor question and computer code to manage the exclusion, as we already do for donors with corneal transplant to meet EU requirements.Â
Harmonization for this deferral may be a matter of time, for example France announced in November 2015 a 12-month deferral for MSM would be coming this spring. The International Plasma Fractionator’s Association (IPFA), with input from their working group on Regulatory Affairs (which includes Blood Centers of America), is working on a science-based position statement to present to the European Medicines Agency for removing MSM deferrals in their directives.
Jenny Ficenec, Senior VP, Plasma & Business Development, Blood Centers of America;Â jficenec@bca.coop