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

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Blood banks and blood products were regulated through the NIH DBS Laboratory of Blood and Blood Products. In the 1950s, the NIH Blood Bank was part of the Laboratory of Blood and Blood Products. Much of the important research completed by the Laboratory was done hand in hand with the NIH Blood Bank. At some point in the late 1950s or early 1960s, the blood bank (which was located in the basement of the NIH Clinical Center) was administratively separated out from the Laboratory of Blood and Blood Products and became part of the Clinical Center (Department of Transfusion Medicine). When the DBS transitioned administratively from the NIH to the Food and Drug Administration (FDA), the Laboratory of Blood and Blood Products’ regulatory role continued in the Division of Blood and Blood Products.

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Dive class grid-col-3 Image Added Dive class grid-col-6 Image Added Dive class grid-col-3 Image Added Center Span class caption Clinical Center Blood Bank Whole Blood Group, Rh, VDRL and Titre Record Donor Book 1953–54. Inscription inside cover identifying the book as belonging to the Clinical Center Blood Bank by Dr. Paul J. Schmidt. Schmidt became the second blood bank director in 1955 and stayed until he retired in 1975. He formulated policies and procedures for the new department (the Clinical Center opened to patients in 1953) and did research as well. Span class credit Office of NIH History & Stetten Museum

Other court cases against blood banks soon followed:

• 1963 - Paterson, NJ blood bank had to surrender its Federal license after an outbreak of hepatitis from its donors.
• 1964 - Newark, NJ, the president of the Paterson Blood Bank, Inc. was charged for falsely labeling blood beyond the 21-day expiration and selling it to hospitals in NJ and NY. The blood bank was also convicted on 20 charges.
• 1968 - Dallas Blood Bank, Charles and Maxine Blank were charged with 27 violations of the Food, Drug and Cosmetic Act, the Public Health Service Act, and two conspiracy statutes. They mislabeled units of whole blood and red blood cells, including changing the blood group, stating results of tests not completed, and extending the date on the blood. On an appeal., Maxine Bank’s conviction was reversed, and the Court of Appeals said that citrated whole blood and red blood cells were not products analogous to a therapeutic serum. Leaving a paradox where blood was considered a drug, but not a biologic. The amendment in 1970 to Section 351 took care of this by adding “blood, blood components and derivatives” to the act. This is the only direct evidence of a Congressional mandate for a Federal regulatory agency to license, inspect, and otherwise regulate blood banks.

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