FDA Releases Final Guidance on MSM Deferral Policy

The Food and Drug Administration (FDA) released its final guidance (Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products: Guidance for Industry) for industry on reducing the risk of HIV transmission through blood and blood products today.

In the guidance, the FDA changed the lifetime deferral to a 12 month deferral for men who have sex with men (MSM). The FDA noted that because there are a number of countries that continue to have a permanent or indefinite deferral policy, there may be some manufacturers of Source Plasma that will not be able to implement the 12 month donor deferral policy for MSM. PPTA and its member companies will begin to assess the impact of the FDA's Final Guidance on global business operations so that patients worldwide continue to access lifesaving plasma protein therapies