Generics study

Executive Summary

Office of Management & Budget clears FTC request to conduct study on Hatch/Waxman's effects on competition between branded and generic drug manufacturers; OMB approval was not deemed clear-cut, since former Eli Lilly exec Mitch Daniels heads the office. FTC will issue special orders to 30 innovator companies and 70 generics firms questioning impact of Hatch/Waxman's 180-day marketing exclusivity and 30-month stay provisions on innovation; firms must reply within 60 days. Study was first proposed last fall (1"The Tan Sheet" Oct. 16, 2000, p. 13)