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After the administrative transfer of the DBS from the NIH to the Food and Drug Administration (FDA) in 1972, Dr. Lewellys Barker moved from the Laboratory of Virology & Rickettsiology to the Division of Blood and Blood Products where he worked from 1973 to 1978. Dr. Barker researched the Hepatitis B virus and its test and vaccine. Dr. John Finlayson and Madge Crouch also worked in Blood and Blood Products.During the late 1990s, the Division of
Blood and Blood Products
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By 2000, there was both the Division of Blood Application and the Office of Blood Research and Review at the FDA’s Center for Biologics Evaluation and Research (CBER).
Blood and Blood Products: Hemophilia
An early blood research project in the FDA Bureau of Biologics concerned provisioning increased supplies of antihemophilic factor through two sources, antihemophilic factor concentrate (AHF) and cryoprecipitated antihemophilic factor (CAF). For example, staff evaluated the possibility of producing the latter from fresh frozen single donor plasma that was beyond its date by assaying samples of donor frozen plasma at different time periods. The Bureau also contracted with the American Red Cross to investigate the harvestability of AHF from blood stored up to about a week. These studies were ongoing.
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The Center for Biologics Evaluation and Research (CBER) licensed Monoclate late in 1987, the first blood product purified by biotechnological techniques, an antihemophilia factor. This was produced from normal human plasma with monoclonal antibodies to extract Factor VIII:C from plasma. This treated hemophilia A, which affects more than 20,000 patients at that time.
The development and licensing of recombinant Factor VIII in 1992 and 1993 eliminated the possibility that the nation’s 10,000 suffering from hemophilia A would have to face the possibility of the transmission of hepatitis or AIDS. Recombinate was the first, licensed in Dec. 1992, and Kogenate received its license in the following February.
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Initial results of a 1999 Bureau of Biologics analysis of a recombinant antihemophilia factor. |
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FDA History Office |
During the late 1990s, the Division of Blood and Blood Products no longer appeared in telephone directories. It may have been reorganized under Hematology or the Division of Blood Application.
By 2000, there was both the Division of Blood Application and the Office of Blood Research and Review at the FDA’s Center for Biologics Evaluation and Research (CBER).
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