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Abstract
This article reviews the regulatory, social, policy, and other issues that will shape the development of pharmacogenomics applications. We identify and analyze 19 key public policy issues, ranging from the economic incentives for linked diagnostic-drug development, to the regulation of tests and drugs, and to privacy and informed consent. Challenging technical, business, and policy-related issues might either hinder progress in the field of pharmacogenomics or potentially accelerate it, depending on how they are addressed and resolved. How well the numerous important stakeholders—both private and public—address these issues will be critical for pharmacogenomics to deliver on its promise.
| ABBREVIATIONS | ||
| ASR: | = | Analyte-specific reagent |
| BRCA: | = | Breast cancer |
| CDC: | = | Centers for Disease Control and Prevention |
| CFR: | = | Code of Federal Regulations |
| CLIA: | = | Clinical Laboratory Improvement Act |
| DNA: | = | Deoxyribonucleic acid |
| DTC: | = | Direct-to-consumer |
| EGAPP: | = | Evaluation of Genomic Applications in Practice and Prevention |
| EAG: | = | External Advisory Group |
| FDA: | = | Food and Drug Administration |
| HIPAA: | = | Health Insurance Portability and Accountability Act |
| IAG: | = | Internal Advisory Group |
| PGx: | = | Pharmacogenomics |
| PharmD: | = | Doctor of Pharmacy |
Acknowledgments
Internal Advisory Group: Karen Edwards, Kelly Fryer-Edwards, Patricia Kuszler, Scott Ramsey, Mark Rieder and Ken Thummel. External Advisory Group: Finley Austin, Eiry Roberts, Wayne Rosenkrans, Brian Spear, and Christopher Webster. Research support was provided by an unrestricted grant by Pharmaceutical Research and Manufacturers of America to the University of Washington. Special thanks are due to Randy Burkholder, the sponsor's project officer.