LAW 980

Issues in Drug Development and Pharmaceutical Innovation

In this course we will examine innovation in the current drug development and approval ecosystem as a part of pharmaceutical policy.  First we will look at an overview of the drug development and approval process, both the standard paths to approval and some of the fast tracks to approval intended to incentive certain types of drugs.  In addition to examining literature on drug innovation, we will discuss examples of drugs that illustrate some features of the current development ecosystem, and research information about drugs from recent FDA novel drug lists.  We will examine the results of this research critically in light of the concerns raised in the literature that suggests innovation may be slowing down, and questioning whether current incentives are producing socially optimal outcomes.  Finally, we will look at proposals about how to improve the costs, quality, and/or social utility of the types of drugs developed and the ways they may impact innovation going forward.

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