115th meeting of the FDA Blood Products Advisory Committee

On April 4, PPTA staff attended the 115th meeting of the FDA Blood Products Advisory Committee in Silver Spring, Md. In the morning, the Biologics License Application of Novo Nordisk's Recombinant Human Coagulation Factor IX, GlycoPEGylated, was discussed. Committee comments focused on the safety of the product, including risks in the intended population, particularly in the pediatric and elderly populations, and in the setting of life-time administration, and whether monitoring—particularly of neurologic function—should be provided for the safety of patients or study subjects.

In the afternoon, the Committee heard an update presentation on a summary of responses to Docket FDA-2016-N-1502: Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products. In December 2015, FDA changed its blood donor deferral policy for men who have had sex with men (MSM) from indefinite to 12 month, among other changes. FDA requested comments—supported by scientific evidence—regarding potential deferral policy options to reduce the risk of HIV transmission, including alternatives to time-based deferral policies and feasibility of individual risk assessment strategies, and design of potential scientific studies on feasibility and effectiveness of alternative deferral options. Of the 670 responses in the docket, 517 were against further change in the deferral policy. The policies suggested in the docket covered a broad spectrum from no further change (or return to an indefinite deferral) to no deferral for low-risk MSM and a 2 to 3 week deferral for MSM determined to be high-risk. FDA also shared progress on the Transfusion-Transmissible Infections Monitoring System (TTIMS) and discussed the Agency's future plans. On April 5, the Committee heard overview presentations on the research programs in the Laboratory of Emerging Pathogens in the Division of Emerging Transfusion-Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA.