Pharmacogenetics adds value with improved clinical markers and increased ability to predict efficacy with greater clarity. This should lead to individualized and simplified dosing, improved efficacy with specific treatment, and enhanced safety. Improved patient response should lead to enhanced patient compliance. Many challenges remain ahead including ethical issues related to patient confidentiality and banking of DNA. Regulatory issues and guidelines need to be discussed to establish reasonable boundaries. There is also a need for review of diagnosis and treatment combinations and Food and Drug Administration review of the process. Legal issues including patents and commercial issues concerning patient, physician, and managed care acceptance must be addressed.