DRUG INNOVATION, REGULATION AND COSTS (HLTH9508)
2 credits. Seminar.

This seminar will examine the process and rationale for the regulation of drugs and medical devices and current issues about the impact of the regulatory scheme. Topics to be covered include whether speeding up drug approval increases safety risks, what lessons are provided by Vioxx, and when comparative efficacy testing of drugs is warranted. Attention will be given to matters that can affect the cost of drugs including the standards for approval of generic drugs, non-patent regulatory protections, and OTC switches. FDA’s role with respect to innovative drugs such as those for human enhancement will be examined.

While there is no prerequisite for the seminar, a course in Food and Drug law is recommended.