Relationships Between Aspects of Pharmaceutical Regulation, Innovation, and Therapeutic Benefits

摘要

The first phase of a research project concerning the impact of regulation on pharmaceutical innovation is described. The project is based on comparisons of regulatory policies, innovation processes, and innovative output and drug benefits for different types of pharmaceuticals. A theoretical framework is presented which includes basic theories of scientific advance and industrial innovation, and a theory of the natural history of drug innovation within therapeutic classes. Useful and potentially useful variables for hypothesis building are defined in relation to aspects of innovation processes, regulatory and non-regulatory stimuli, innovative output, and therapeutic benefits. Preliminary observations are made of relationships between these variables. Also presented are preliminary inferences from work done to date and generic types of information on drug innovation/regulation relationships likely to be helpful to the Food and Drug Administration, industry, and Congress. Tentative hypotheses for future work are included.