Liability Issues in Pharmacogenomics

Abstract:     
Liability concers involving toxicogenomics inevitably raise broad issues of ethics and policy. The first of these issues, often called "genetic exceptionalism" deals with wether genetic is so unique that is should be considered seperately from other medical information. In other words, is there something different about pharmacogenomics as opposed to any other pharmaceutical research discipline? Is there something unique about drug development strategies and drug regulation involving pharmacogenomics compared with traditional drug development strategies and regulation? Is there something different about liabilty issues for manufacturers and health care providers involved with this technology? These question will inform our analysis of pharmacogenomics.

Number of Pages in PDF File: 8

Keywords: genetics, genomics, pharmacogenomics, products liability, negligence, pharmaceuticals, FDA, direct to consumer advertising, off-label uses

JEL Classification: K31, K32

Accepted Paper Series