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In addition to these moves in the regulation of blood, the Bureau quickly proposed revisions to the licensing standards for blood plasma, the source for various products including gamma globulins, antihemophilic factor, and serum albumin. Also, as mentioned earlier, previously only about 500 interstate blood banks were regulated by the federal government; the 6000-7000 intrastate blood banks operated with little to no oversight. The Bureau invoked authorities under the 1938 Food, Drug, and Cosmetic Act to apply to all blood collection and processing centers. Blood banks and other blood collection facilities now had to be registered and inspected. Plasmapheresis centers (sites where blood is collected, the plasma is separated from the red blood cells, the latter are returned to the patient, and the plasma either treated and returned or repurposed) had to be licensed and inspected. Nearly 6000 establishments were registered in the first 15 months, and Bureau and Bureau-trained field office personnel inspected about 1000. The Bureau trained FDA field investigators such that the latter were able to take over the inspection responsibilities of the nearly 250 plasmapheresis facilities by 1977. Two years earlier FDA for the first time revoked a biologics establishment license for cause, a recidivist plasmapheresis firm. In 1977 FDA pursued its first criminal prosecution of a plasmapheresis firm. In this case, the corporation was charged with providing false documents to FDA, intentional and non-intentional violations of the Food, Drug, and Cosmetic Act by adulterating and misbranding plasma, and violation of the Public Health Service Act by misbranding a biological product. A jury found the three charged officers of the firm guilty. Each was sentenced to 18-24 months in prison and their company fined $27,000. The plasmapheresis center and its ancillary facilities were enjoined and closed.

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Despite the 1988 voluntary agreement agency inspections of ARC facilities across the nation continued to present compliance failures, followed by formal regulatory notices and initiation of proceedings to revoke establishment licenses. In May 1993 ARC agreed to a consent decree, enforceable by court order, that stipulated a comprehensive series of changes to ensure the safety of the nation’s blood supply and the integrity of ARC’s blood program. Among the changes:  establishing a clear line of managerial control over quality control in all regions;  establishing a comprehensive quality control program;  enhancement of a training program to be required—along with an annual competency review—for all staff engage in blood programs, improvement of its computer system, records management, and its policies for following up on reporting errors, accidents, and adverse events; and annual performance audits of each of its 47 blood program regions.

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In July 1986 FDA licensed the first therapeutic monoclonal antibody, Muromonab CD-3, to treat acute rejection of transplanted kidneys.  The biologic bound to the T cell CD-3 antigen and rapidly dispatched the T lymphocytes.

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In 1990, CBER approved the use of live bacteria to treat bladder cancer. BCG Live (after bacillus Calmette-Guérin), a freeze-dried suspension, was delivered directly to the bladder via a catheter to treat pathogenic cells lining the inner surface of the organ—and thus a treatment designed for earlier stages of the illness. The patient retained the product for two hours before voiding, and the treatment would be repeated for the next several weeks or months.

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