title: Regulatory approval for new pharmacogenomic tests: a comparative overview.
abstract: Pharmacogenomics is the study of how genetic variants affect the way in which an individual or subgroup responds to drugs. This developing field aims to inform individual drug therapy and to minimize adverse drug reactions (ADRs). It also promises great benefits in the drug development process. Innovation in pharmacogenomics and its translation into clinical practice is desirable, but appropriate regulation of the safety and effectiveness of pharmacogenomics testing is necessary. This article will describe the current regulatory framework applicable to pharmacogenomic tests in Canada, the United States and Europe. In particular, it will examine the different regulatory pathways for pharmacogenomic tests marketed as test kits and for laboratory-developed tests (LDTs). Recent and upcoming changes to the regulation of pharmacogenomic tests will also be discussed. For example, FDA's proposal to regulate LDTs could have a major impact on the development and availability of pharmacogenomic tests. This review will lead to an evaluation of the issues raised by the regulatory framework and the impact of regulatory changes in relation to meeting the goals of ensuring public safety and promoting the advancement of pharmacogenomics. Regulatory policies which successfully achieve the dual objectives of ensuring public safety and promoting innovation in health technology are imperative in order to reap the benefits of this emerging field.
authors: Centre for Genomics and Policy, Faculty of Medicine, McGill University.
authors: Yann
authors: Y
authors: Joly
authors: The Centre for Genomics and Policy, Faculty of Medicine, McGill University.
authors: Georgia
authors: G
authors: Koutrikas
authors: Centre for Genomics and Policy, Faculty of Medicine, McGill University.
authors: Anne-Marie
authors: AM
authors: Tassé
authors: Program in Personalized Medicine & Targeted Therapeutics, University of Houston, USA.
authors: Amalia
authors: A
authors: Issa
authors: Pharmaceutical Outcomes Programme, BC Children's Hospital, University of British Columbia, Vancouver, Canada.
authors: Bruce
authors: B
authors: Carleton
authors: Department for Medical Genetics, University of British Coumbia, Vancouver, Canada.
authors: Michael
authors: M
authors: Hayden
authors: Department of Paediatrics, Children's Hospital at London Health Sciences Centre, London, Canada.
authors: Michael J
authors: MJ
authors: Rieder
authors: Centre for Genomics and Policy, Faculty of Medicine, McGill University.
authors: Emma
authors: E
authors: Ramos-Paque
authors: Centre for Genomics and Policy, Faculty of Medicine, McGill University.
authors: Denise
authors: D
authors: Avard
mesh_terms: D002170:Canada; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D015195:Drug Design; D055808:Drug Discovery / Q000191:economics / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis / Q000517:prevention & control; D005060:Europe; D005820:Genetic Testing / Q000331:legislation & jurisprudence* / Q000379:methods; D006801:Humans; D010597:Pharmacogenetics / Q000331:legislation & jurisprudence*; D013678:Technology, Pharmaceutical / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D002945:Cisplatin