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In February 1973 FDA finalized plans to conduct a systematic efficacy review of all licensed biological products, modeled on its review of over-the-counter drug products that had been launched the previous year.  Commissioner Charles Edwards appointed six advisory panels of experts that would review the evidence and assign each biological product to one of the following categories:  safe and effective; unsafe and/or ineffective;  requiring further study but to remain available in the interim;  and lacking sufficient data to be determined safe and effective and recommended for market removal.  Much as the case with new drugs, the proof of effectiveness would be expected to derive from adequate and well-controlled investigations.  And much like the case with drugs, the review lasted decades.  Along the way, though, some licenses have been revoked, such as in 1977 when FDA announced its intention to revoke the licenses of eight skin tests for tuberculosis, diphtheria, and other diseases and conditions.

Center for Biologics Evaluation and Research

The FDA Center for Biologics Evaluation and Research (CBER) is the home of biologics regulation today. When DBS was administratively transferred from the NIH to the FDA, it was called the Bureau of Biologics. During the 1980s and 1990s there was significant organizational change in biologics at the FDA. In 1982, the Bureau of Biologics merged with the Bureau of Drugs to form the National Center for Drugs and Biologics (NCDB). In 1983, the biologics component was renamed the Office of Biologics Research and Review (OBRR) within the Center for Drugs and Biologics (CDB). In 1988 more changes happened when the CDB separated into two centers: the Center for Biologics Evaluation and Research (CBER), which was formerly the OBRR, and the Center for Drug Evaluation and Research (CDER). CBER has remained the name for the biologics regulation team at the FDA ever since. In 2002, some functions of CBER were transferred to CDER, to allow CBER to focus on regulating vaccines, gene therapy, tissue transplantation, and blood safety. FDA’s review of new pharmaceutical products, which had been partially done by both CBER and CDER in the past, would be consolidated to CDER.

Architectural Documentation

Historic American Buildings Survey (HABS) architectural documentation of Buildings 29 and 29A at the NIH is part of the efforts to mitigate the adverse effects of the planned demolition of the buildings. The survey and fieldwork were completed July 12–14, 2021. The HABS materials will be available on the Library of Congress website in addition to portions of them being presented in this exhibition. This online exhibition on Buildings 29 and 29A and the research conducted there is also a part of the mitigation process.

The FDA Center for Biologics Evaluation and Research (CBER) moved from the NIH to the FDA White Oak Campus in 2014. This move completely vacated Buildings 29, 29A, and the circa-1994 Building 29B. Building 29B has been reoccupied by NIH staff, following moderate renovation. NIH completed feasibility studies and determined in 2020 that it is not viable to reuse Buildings 29 and 29A, and demolition is planned. As these are historic buildings on Federal property, Section 106 of the National Historic Preservation Act (NHPA) and its implementing regulations (36 CFR §800) must be followed. A Memorandum of Agreement (MOA) was entered into between the NIH and the State Historic Preservation Office, the Maryland Historical Trust (MHT), since demolition of buildings is an adverse effect to historic properties. This online exhibition and the aforementioned HABS architectural documentation are the result of that agreement. While Buildings 29 and 29A are no longer in use, their legendary staff and their important work lives on.

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