chapter  6
12 Pages

FDA’s Antibiotic Regulatory Scheme: Then and Now

WithIrving L. Wiesen, Esq.

INTRODUCTION An antibiotic is a drug containing any quantity of any chemical substance produced by a microorganism and which has the capacity to inhibit or destroy microorganisms in dilute solution (1). AQ 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 FDA, within the statutory mandate, increasingly revised the regulatory requirements governing antibiotic drugs, gradually eliminating them in successively more radical revamping 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, which finally and unambiguously put an end to the particular, and peculiar, requirements for antibiotic drugs.