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

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• 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.

FDA Research related to Blood and Blood Products

The FDA Bureau of Biologics research into cytomegaloviruses (CMV), beginning in 1973, aimed to promote further safety in the blood supply. The presence of CMV in those receiving large volume transfusions suggested that these might reside in the leukocytes of some donors. A recent study found that two out of 35 specimens of donor leukocytes had CMV. Though the Bureau had not yet confirmed this finding, routine testing for CMV could lessen risk in the blood supply.

In addition, the FDA Bureau of Biologics investigated the impact of phthalates leached from plastic bags used to store blood on human blood lymphocytes during the three-week storage period. No notable chromosomal damage was found, such that it could be concluded that phthalate did not produce a significant increase in chromosomally aberrant cells that could be transfused in humans.

In 1978, the Bureau of Biologics approved a preservative for whole blood and red blood cells that significantly lengthened the shelf life of these products. Previously, these could be stored for only up to 21 days, but the new preservative, citrate phosphate dextrose adenine (CDPA-1) extended that by more than two-thirds, to 35 days.  

Three tests to detect HTLV-1, a retrovirus associated with both Adult T-cell Lymphoma and tropical spastic paraparesis received licenses in 1988. Since this virus appeared to be transmitted through the blood supply, these tests offered another valuable tool to blood collection and processing facilities to screen donated blood.