ABSTRACT
I. INTRODUCTION The pharmaceutical industry of the 1990s is facing increasing challenges. The race to new drug approval is now further complicated by increased cost-containment pressures and liability concerns. The expectation for pharmaceutical companies to “economically” develop safe and efficacious drugs that provide added value to the health care marketplace has caused pharmaceutical com panies to reevaluate their drug development process. Among the many trends and events that are shaping the future of new drug development, several are paramount. This chapter identifies and analyzes emerging cost-containment and product liability trends that have impacted on the drug development proc ess. It concludes with a look at how these factors might affect future drug development and patient access to new pharmaceuticals.
