Globalizing the FDA: Achieving safety,access,and transparency through a comprehensive Generic Drug User Fee Program *

Abstract

The globalization of drug manufacturing, supply and testing, and a growing workload that has far outpaced FDA’s resources has created new challenges. The US generic industry recognized the importance of working in partnership with FDA to increase critical agency capacity to address the need for globalization of the inspection process, and to speed the timely review of generic product applications and proposed a holistic user fee program to help the FDA obtain the additional resources needed to ensure all participants in the U.S. generic drug system, whether US-based or foreign, comply with FDA’s high-quality standards and to make certain Americans get timely access to more affordable, high-quality generic drugs. The Generic Drug User Fee Act proposal (GDUFA) agreed to by industry and FDA is focused on three key aims: safety, access, and transparency. GDUFA also will help accelerate the market entry of additional manufacturers of drugs currently in short supply and improve quality, consistency, and availability within the supply chain, further helping to mitigate drug shortages caused by interrupted access to raw materials such as active pharmaceutical ingredients. Based on the proposal that will be submitted to Congress GDUFA would officially begin on October 1, 2012 and generate a total generic drug user fee package of $299 million per year for 5 years. In exchange for these fees, the FDA is to strive to meet key metrics which the agency must report to Congress each year, in addition to a host of other goals, metrics and efficiencies.