title: DNA, drugs and chariots: on a decade of pharmacogenomics at the US FDA.
abstract: Over the past 10 years, the US FDA has become a strong pharmacogenomics advocate as part of its mission to both protect and advance public health by enabling innovations that make medicines safer to use and more effective. The agency has evolved its advocacy cautiously on a foundation of science-based information from novel programs, such as the Voluntary Genomics Data Submission initiative, and on careful regulatory assessment of the extraordinary advances in clinical pharmacogenomics that have supported the update of drug labels with genetic information. This commentary goes into detail on the evolution of these achievements. However, many challenges remain for pharmacogenomics, and they will continue to evolve, and all stakeholders must work together. As the decade draws to a close, we have presented four major areas that need to be addressed collectively to assure that pharmacogenomics continues to mature over the next 10 years into a science that is essential to the practice of medicine.
authors.affiliation: Office of Clinical Pharmacology, Center for Drug Evaluation & Research, US FDA, HFD-850, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. lawrence.lesko@fda.hhs.gov
authors.forename: Lawrence J
authors.initials: LJ
authors.lastname: Lesko
authors.forename: Issam
authors.initials: I
authors.lastname: Zineh
mesh_terms: D004247:DNA / Q000235:genetics*; D004348:Drug Labeling / Q000639:trends; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000378:metabolism / Q000592:standards*; D010597:Pharmacogenetics / Q000379:methods* / Q000639:trends; D057285:Precision Medicine / Q000379:methods* / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations; D004247:DNA