Biologics Regulation and ResearchThe People and Work of Buildings 29 & 29A

Jay S. Epstein, M.D. (dates unknown)

Dr. Jay Epstein received his bachelor’s degree from Harvard University in 1969 and his medical degree from the State University of New York, Medical College at Downstate in 1976. Epstein completed training in internal medicine and clinical infectious diseases at the George Washington University Hospital in 1981. He was a Food and Drug Administration (FDA) staff fellow in virology research from 1981 to 1985. He served as a Public Health Services commissioned officer from 1985 to 1988.

Headshot of Jay Epstein

World Health Organization (WHO)

When the Division of Biologics Standards (DBS) was transferred administratively from the National Institutes of Health (NIH) to the FDA in 1972, there were several organizational name changes. Biologics was renamed the Center for Biologics Evaluation and Research (CBER). Epstein has been the director of the Office of Blood Research and Review at the FDA’s CBER since 1995.

He was the primary individual responsible for scientific review, policy development, and regulation relevant to the safety, efficacy, and availability of blood components for transfusion, plasma derivatives (e.g. albumin, clotting factors, immune globulins, etc.), analogous recombinant plasma proteins, and drugs and devices related to manufacture of these products. Under his leadership, the FDA implemented safety controls for human immunodeficiency virus (HIV), human T-lymphotropic virus (HTLV), hepatitis C, hepatitis B, hepatitis A, syphilis, cytomegalovirus (CMV), West Nile virus, Chagas disease, human parvovirus B19, transmissible spongiform encephalopathies (TSE) agents, Ebola virus, and Zika virus and established standards for approval of AIDS-related diagnostic tests. He licensed or approved more than 100 biologics products and devices based on determinations of their safety and clinical efficacy, and established control programs including biological reference reagents, to assure their purity, potency, and manufacturing consistency.

Epstein is the author of more than 150 peer-reviewed scientific papers and numerous review articles and book chapters in the field of blood-safety regulation.

He has received numerous accolades throughout his career including awards from the FDA, the Department of Health and Human Services, and patient stakeholder honor awards. In 2019, he received the Richard K. Davey Award at the NIH Clinical Center Department of Transfusion Medicine’s 38^th Annual Immunohematology and Blood Transfusion Symposium. He is also a member of the World Health Organization Advisory Panel on Biological Standardization, serving as a Senior Advisor for International Blood Regulatory Affairs.

Dr. Epstein worked in Building 29, Room 324, and in the FDA’s Woodmont Building in Rockville, Maryland.