Richard L. Schilsky, MD

Richard L. Schilsky, MD, Chief of Hematology/Oncology in the Department of Medicine and Deputy Director of the University of Chicago Comprehensive Cancer Center, discusses the impact that sequestration had on the FDA.

In addition to drug shortages, sequestration has recently begun to impact the FDA and other government industries in other ways. The FDA has encountered problems with staffing and sending representatives to scientific meetings.

Schilsky says that an FDA official informed him that the administration used to send 30-40 officials to the American Society of Clinical Oncology Meeting, but only sent three in 2013. This can have a negative impact as the physicians responsible for determining what drugs go to the market cannot even attend meetings to hear data about various drugs.

In addition to drug shortages, sequestration has recently begun to impact the FDA and other government industries in other ways

The FDA has encountered problems with sending representatives to scientific meetings, including the ASCO Annual Meeting

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Richard L. Schilsky, MD, from the University of Chicago Comprehensive Cancer Center, discusses the impact that sequestration had on the FDA.

The Impact of Sequestration

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.

70% of all generic drugs in the world are made by three manufacturers

80% of all generic drugs are made by five manufacturers

Generic drug user fees will hopefully give resources to the FDA to reduce application review times

View all coverage from the 2013 ASCO Meeting

Richard L. Schilsky, MD, from University of Chicago Comprehensive Cancer Center, explains the benefit to generic drug user fees.

Richard L. Schilsky, MD | Authors

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The Impact of Sequestration

The Benefit of Generic Drug User Fees