The history of regulatory system for plasma fractionation products in the United States

Abstract

In Japan, biologics have been described as special sorts of medicines in the Pharmaceutical Affairs Law and are regulated by the Ministry of Health, Labour and Welfare (MHLW). In contrast, in the United States, some of the regulatory laws for biologics are different from other medicines and the relevant regulatory agencies have been changed historically. We reviewed the histories of the laws and changes in regulatory agencies for biologics, especially focusing plasma fractionation products in the United States, which may give suggestions and advice for the regulation of biologics in Japan. In the earliest stage, biologics were regulated by the Biologics Control Act (BC Act) of 1902 and as parts of the Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938. The effectiveness of these regulations was not equivalent to that of other drugs; therefore, Congress passed some amendments to the FD&C Act, in which biologics were treated in the same way as other drugs. In 1972, the authority for biologics control was transferred from the National Institutes of Health (NIH) to the Food and Drug Administration (FDA). Thereafter, in order to achieve the most efficient regulation under the rapidly evolution of biologics, the biologics regulating sections in the FDA have changed several times. At present, some biologics that are used in ways similar to other drugs (e.g., cytokines, monoclonal antibodies and immunomodulators) are regulated by the Center for Drug Evaluation and Research (CDER), and other biologics (e.g., vaccines, blood products and cellular products) are regulated by the Center for Biologics Evaluation and Research (CBER) of the FDA. PMID: 25799842 [Indexed for MEDLINE]