title: A review of public policy issues in promoting the development and commercialization of pharmacogenomic applications: challenges and implications.
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.
authors.affiliation: Department of Pharmacy, University of Washington, Seattle, Washington 98195, USA. lgarrisn@u.washington.edu
authors.forename: Louis P
authors.initials: LP
authors.lastname: Garrison
authors.forename: Rick J
authors.initials: RJ
authors.lastname: Carlson
authors.forename: Josh J
authors.initials: JJ
authors.lastname: Carlson
authors.forename: Patricia C
authors.initials: PC
authors.lastname: Kuszler
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Meckley
authors.forename: David L
authors.initials: DL
authors.lastname: Veenstra
mesh_terms: D003257:Consumer Product Safety; D017277:Drug Approval; D016527:Drug Costs; D015195:Drug Design; D033141:Genetic Determinism; D030661:Genetic Privacy / Q000331:legislation & jurisprudence; D005820:Genetic Testing / Q000191:economics / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D006801:Humans; D007258:Informed Consent; D007349:Insurance, Health, Reimbursement; D008389:Marketing of Health Services / Q000191:economics / Q000331:legislation & jurisprudence*; D010597:Pharmacogenetics / Q000191:economics / Q000331:legislation & jurisprudence*; D011640:Public Policy; D014481:United States