The legislative history leading to the codification of the 1902 Biologics Control Act into the 1944 Public Health Service Act included a proposal that biological products have ‘efficaciousness’ in addition to the safety, potency, and purity requirements already in the statute. However, the proposed additional requirement of efficaciousness was not carried into the 1944 Act. In March 1972, the Government Accounting (later called Accountability) Office (GAO) reported that DBS had not required effectiveness of biological products despite the fact that they were also ‘drugs’ under the statutory definition, and drugs had to be effective as well as safe under the 1962 Amendments to the Food, Drug, and Cosmetic Act. In the same month, NIH announced its intention to review all of its biological products and issued a call for substantial evidence of effectiveness, the standard that was applied to drugs. During a May 1972 Congressional hearing, Department of Health, Education, and Welfare (DHEW) Secretary, Elliott Richardson, announced that DBS should be transferred to FDA, which was carried out the following month.

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When the NIH staff of nearly 270, including more than 100 scientists and health professionals, were transferred officially to the FDA on July 1, 1972, the core work of biologics regulation and research remained the same:  licensing both manufacturers and their products, creating the physical and written standards and carrying out the necessary research to apply to biological products, inspecting manufacturing facilities to confirm compliance with standards, testing product samples prior to their commercial distribution, and monitoring experiments involving new biological materials (investigational new drugs).

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.

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