On April 2, 2020, in the morning, the BPAC will meet in open session to discuss and make recommendations on strategies to reduce the risk of ZIKV transmission by blood and blood components. The committee will discuss whether universal testing of blood donations for ZIKV is an appropriate strategy considering the decline of ZIKV cases in the United States and worldwide. In the afternoon, the committee will meet in open session to hear an update on the TTIMS. Sponsored by the FDA, the National Institutes of Health National Heart, Lung and Blood Institute,and the Department of Health and Human Services Office of the Assistant Secretary for Health, TTIMS collects incidence, prevalence and risk factor data for certain transfusion-transmitted infections, including human immunodeficiency virus, in U.S. blood donations.

On April 3, 2020, the committee will meet in open session to discuss and make recommendations on testing for hepatitis B surface antigen (HBsAg) in blood donations. The committee will discuss whether testing for HBsAg can be discontinued considering the sensitivity of hepatitis B virus nucleic acid testing and hepatitis B anti-core testing of blood donations in the United States.

Update: On March 11, 2020, the FDA postponed this meeting until further notice. The Agency stated, “The FDA, like other government agencies, is taking the necessary steps to ensure the agency is prepared to continue our vital public health mission in the event that our day-to-day operations are impacted by the COVID-19 public health emergency. Therefore, we are canceling or postponing all non-essential meetings through the month of April. We will reassess on an ongoing basis for future months. Where possible the agency will leverage technology to host meetings allowing for remote participation.”

In the afternoon, the committee met in open session to hear an overview of the research programs in the Laboratory of Biochemistry and Vascular Biology in the Division of Blood Components and Devices, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA.

On March 21, 2019, the committee met in open session to discuss blood donation policies regarding men who have sex with men (MSM). The committee heard presentations on the current epidemiology of HIV in the United States; global developments in MSM blood donor deferral policies; and data on HIV incidence and prevalence among blood donors from the Transfusion-Transmitted Infection Monitoring System. The committee discussed a proposed HIV risk questionnaire study. In addition, the committee discussed a proposal for the use of pathogen reduction technology as an alternative procedure to a time-based deferral for MSM.  

On the first day of the meeting, the Committee will provide advice regarding bacterial risk control strategies to enhance the safety and availability of platelets for transfusion. On the second day of the meeting, the Committee, supplemented with members from the Microbiology Devices Panel of the Medical Devices Advisory Committee, will function as a medical device panel to provide advice and recommendations to the Agency on classification of devices.

In the morning open session, under Topic 1, the Committee will hear presentations on the research programs in the Laboratory of Emerging Pathogens (LEP), Laboratory of bacterial and TSE Agents (LBTSE), and from the Laboratory of Molecular Virology (LMV) in the Division of Emerging Transfusion-Transmitted Diseases (DETTD), Office of Blood Research and Review (OBRR), Center for Biologics Evaluation and Research (CBER), FDA. After the conclusion of the open session, the meeting will be closed to permit discussion where disclosure would constitute an unwarranted invasion of personal privacy in accordance with 5 U.S.C 552b(c)(6). In the afternoon, in open session, under Topic II, the Committee will hear presentations on the research program in the Hemostasis Branch (HB), in the Division of Plasma Protein Therapeutics (DPPT), Office of Tissues and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER), FDA. After the open session, the meeting will be closed to the public to permit discussion where disclosure would constitute an unwarranted invasion of personal privacy in accordance with 5 U.S.C 552b(c)(6).

The BPAC and the Microbiology Devices Panel of the Medical Devices Advisory Committee met on Thursday, March 22, 2018. The Wednesday, March 21, 2018 meeting date was cancelled due to inclement weather.

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 reviewed topics related to the safety of donated blood.

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.