Federally funded programs, productivity

This project has been funded in whole or in part with federal funds from the National Cancer Institute, National Institutes of Health, under Contract NOI-CO-I2400. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organization imply endorsement by the U.S. Government. This research was supported in part by the Developmental Therapeutics Program in the Division of Cancer Treatment and Diagnosis of the National Cancer Institute. 

NIH is a key element in a partnership that has thrived for decades and includes universities and academic health centers, independent research institutions, and private industry, where research programs and product development activities help make federally funded research findings more widely available. The partnership, which has produced many of the medical advances that benefit Americans today, also includes voluntary and professional health organizations, and the Congress, which consistently has supported this vast enterprise. 

Our purpose in preparing this paper and participating in this symposium is to increase productivity in federally funded R D programs and resultant commercialization. We feel that as the result of pointing out the problems and describing examples, the situation will be better understood by everyone and that existing practices will be modified. There are two major points that we would like to make. 

The clinical research tax credit (discussed in chapter 8), protocol assistance, and clinical research grants theoretically lower the cost of orphan drug R D the market exclusivity provision increases the expected revenues to such R D. In practice, the protocol assistance has had little effect, especially in recent years, and the tax credit and grants program represent, overall, a relatively small commitment of Federal funds to orphan products. This commitment may be critical for certain drugs, however, so it should not be discounted. 

---