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Regulation of the biologics marketplace can take many different forms and must be equipped to pivot quickly to address countless threats to public health. For example, Congress appropriated $300,000 for FDA to hire 48 temporary investigators to help prevent the diversion of DBS-cleared lots of licensed Salk polio vaccine from legitimate distribution channels—those used by the six producers to ship vaccine to the states and then to public and private distributors. FDA provided the training, oversight, and on-site assistance for the temporary staff. Though unclear how long this program would last, the agency did not encounter any missing vaccine. A case from 2003 illustrated another turn the regulation of biologics could take. FDA’s Office of Criminal Investigations, established only shortly before, announced the discovery of counterfeit Procrit (epoiten alfa) in the marketplace. Some samples were contaminated with bacteria, and FDA laboratories found others completely lacking in active ingredient. Both the manufacturer and FDA alerted healthcare providers and patients as well to the problem and the lot numbers in question. Four months later Criminal Investigations criminal investigations announced three convictions in this case, though it was unclear if patients had been injured by the counterfeit product.

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FDA issued the first license for human leukocyte typing sera in 1975, making it broadly available for use in identifying potential donors for organ transplants and transfusions.  The following year the Bureau established a histocompatibility testing laboratory to provide quality assurance testing and to create reference standards for anti-human leukocyte typing serums proposed for commercial release.  In In 1982 the Bureaus of Biologics and the Bureau of Medical Devices agreed, and the FDA Commissioner approved that leukocyte typing sera would be delicensed and regulated as an in vitro diagnostic under the Medical Device Amendments of 1976.

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