Richard L. Schilsky, MD, from University of Chicago Comprehensive Cancer Center, explains the benefit to generic drug user fees.
Richard L. Schilsky, MD, Chief of Hematology/Oncology in the Department of Medicine and Deputy Director of the University of Chicago Comprehensive Cancer Center, explains the benefit to generic drug user fees.
In the world, 70% of all generic drugs are made by three manufacturers and 80% are made by five manufacturers. Schilsky points out that these manufacturers have a very thin profit margin on many drugs and have tough decisions to make when problems arise.
One reason generic drug user fees are so important to the FDA is that there is a huge backlog of applications to review. The hope is that generic drug user fees will give resources to the FDA to help reduce review times.