ABSTRACT
The history of antibiotic* regulation demonstrates the interplay between regulatory schemes, which are artifacts of history, and the scientific/regulatory constraints and marketing conditions in which they operate. Largely an outgrowth of a narrow legislative fix of a scientific and regulatory need, the antibiotic regulatory scheme grew to unwieldy proportions as the market for such drugs increased. Accordingly, the U.S.
Food and Drug Administration (FDA), within the statutory mandate, increasingly revised the regulatory requirements governing antibiotic drugs, gradually eliminating them in successively more radical revampings of its drug approval requirements. This window into FDA rule and policymaking finally closed in 1997, when Congress enacted the Food and Drug Administration Modernization Act (FDAMA), which finally and unambiguously put an end to the particular-and peculiar-requirements for antibiotic drugs.
