title: Pharmacogenomic Biomarkers: an FDA Perspective on Utilization in Biological Product Labeling.
abstract: Precision medicine promises to improve both the efficacy and safety of therapeutic products by better informing why some patients respond well to a drug, and some experience adverse reactions, while others do not. Pharmacogenomics is a key component of precision medicine and can be utilized to select optimal doses for patients, more precisely identify individuals who will respond to a treatment and avoid serious drug-related toxicities. Since pharmacogenomic biomarker information can help inform drug dosing, efficacy, and safety, pharmacogenomic data are critically reviewed by FDA staff to ensure effective use of pharmacogenomic strategies in drug development and appropriate incorporation into product labels. Pharmacogenomic information may be provided in drug or biological product labeling to inform health care providers about the impact of genotype on response to a drug through description of relevant genomic markers, functional effects of genomic variants, dosing recommendations based on genotype, and other applicable genomic information. The format and content of labeling for biologic drugs will generally follow that of small molecule drugs; however, there are notable differences in pharmacogenomic information that might be considered useful for biologic drugs in comparison to small molecule drugs. Furthermore, the rapid entry of biologic drugs for treatment of rare genetic diseases and molecularly defined subsets of common diseases will likely lead to increased use of pharmacogenomic information in biologic drug labels in the near future. In this review, we outline the general principles of therapeutic product labeling and discuss the utilization of pharmacogenomic information in biologic drug labels.
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research,U.S. Food and Drug Administration, Silver Spring, Maryland, USA. Robert.Schuck@fda.hhs.gov.
authors.forename: Robert N
authors.initials: RN
authors.lastname: Schuck
authors.affiliation: Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research,U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Grillo
mesh_terms: D001688:Biological Products / Q000378:metabolism / Q000592:standards*; D015415:Biomarkers / Q000378:metabolism; D004348:Drug Labeling / Q000379:methods / Q000592:standards*; D006801:Humans; D010597:Pharmacogenetics / Q000379:methods / Q000592:standards*; D057285:Precision Medicine / Q000379:methods / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*
chemical_list: D001688:Biological Products; D015415:Biomarkers
keywords: Pharmacogenomics; biomarkers; precision medicine