FDA Advisory Committees - FDA Center for Biologics Evaluation and Research (CBER) - Blood Products Advisory Committee (BPAC)
The Committee discussed and voted on the following topics:
· Bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion;
· Device classification of human leukocyte antigen, human platelet antigen, and human neutrophil antigen devices; and
· Strategies to reduce the risk of transfusion-transmitted Zika virus.
The Committee also heard information about the April 6, 2017 FDA public workshop on emerging tick-borne diseases and blood safety, as well as the Transfusion Transmissible Infections Monitoring System.
The Committee met to discuss Novo Nordisk’s Biologics License Application (BLA 125611), for Recombinant Human Coagulation Factor IX, GlycoPEGylated. The product is also referred to as nonacog beta pegol or N9-GP.
In a separate Tuesday afternoon session, the Committee heard 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.
On Wednesday, April 5, 2017, the Committee heard 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.
The Committee met by teleconference to discuss the research programs in the Laboratory of Plasma Derivatives in the Division of Hematology Research and Review, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA.
On Wednesday, May 13, 2015 the Blood Products Advisory Committee (BPAC) voted about strategies for implementation of serological and nucleic acid testing for Babesia microti in blood donors. In addition, the Committee heard update presentations on the following topics: 1) FDA considerations for Hemoglobin S Testing in blood donors; and 2) FDA considerations for a revised blood donor deferral policy for men who have sex with men. Following the update presentations, the Committee heard presentations on the research programs of the Laboratory of Cellular Hematology, Division of Hematology Research and Review, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA.
11 of 14 members voted that the scientific data support the concept of nation-wide, year-round testing of blood donors for Babesia-risk by an antibody-based test.
The Committee unanimously voted that nucleic acid based testing (NAT) should be performed for blood donations in certain high-risk states.
In particular, 8 of 14 members voted that NAT should be performed year-round, in addition to year-round antibody testing in blood donors in the nine highest endemic states. 6 of 14 members voted that both tests should be performed year round in 15 states plus the District of Columbia (DC). This grouping of states plus DC represents the largest risk capture with the smallest number of states.
The nine highest endemic states are: Connecticut, Massachusetts, Rhode Island, New York, New Jersey, Minnesota, Wisconsin, New Hampshire, and Maine.
The 15 states plus DC that represent the largest risk capture with the smallest number of states includes: Connecticut, Massachusetts, Rhode Island, New York, New Jersey, Minnesota, Wisconsin, New Hampshire, Maryland, Maine, DC, Virginia, Vermont, Pennsylvania, Delaware, and Florida.
Blood Products Advisory Committee (BPAC)
BPAC reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of the following
- products derived from blood and serum
- or biotechnology
which are intended for use in the diagnosis, prevention, or treatment of human diseases, and, as required, any other product for which the FDA has regulatory responsibility, and advises the Commissioner of Food and Drugs of its findings.