Obsolete to Useful to Obsolete Once Again: A History of Section 507 of the Food, Drug, and Cosmetic Act

George Maliha


Section 507 of the FDCA regulated antibiotic approval and production for decades. This paper explores the history of Section 507 and places it into the context of the history of antibiotic development. The paper also addresses the central paradox of Section 507. On one hand, Section 507 was one of FDA’s first forays into regulating effectiveness, and it helped foster acceptance of broader pharmaceutical regulation. On the other, advances in medicine and science rendered the enactment anachronistic. In fact, FDA repurposed the program to facilitate generic development and drug testing, potentially delaying the provision’s eventual repeal in 1997.