FDA, Reform, and the Well-Characterized Biologic

摘要

When is a drug not treated like a drug? When it's a biotechnology pharmaceutical product. Confused? You're not alone. Medical products that could be considered drugs fall into at least two categories under Food and Drug Administration (FDA) regulations, under which they have been governed by two different sets of rules. The question with which FDA is now grappling is this: Are these regulatory differences justified given the sophistication of modern analytical techniques? For most people, the answer is "no", and FDA seems to agree, although people in the biotechnology industry are uncertain about where FDA stands. The two categories for these products are "drugs", such as aspirin, which are regulated by the Center for Drug Evaluation and Research (CDER), and "biologies", vaccines and the newer biotechnology products, most of which are regulated by the Center for Biologies Evaluation and Research (CBER). The regulatory framework that governs traditional synthetic Pharmaceuticals—common prescription and over-the-counter medications—was established in the 1938 Food, Drug, and Cosmetics Act. Biotechnology products such as tissue plasminogen activator (TPA), which is used for the treatment of blood clots; erythropoietin (EPO), which is used in the treatment of kidney disease; and the interferons (antiviral agents) are regulated under the 1944 Public Health Service Act, as are vaccines and blood products. The confusion does not end there, however, because some biotechnology pharmaceutical products, such as re-combinant insulin and human growth hormone, are regulated by CDER.