FDA Announces Availability of Clinical Pharmacogenomics Guidance


  • January 28, 2013

By Nick Fleischer, R.Ph., Ph.D.

Pharmacogenomics is recognized as a significant tool for the optimization of drug therapy as well as improving the drug development process. The FDA identified approximately 100 drug labels that contain pharmacogenomic biomarker information which can be relied on to improve the opportunity for maximizing efficacy while reducing the occurrence of potential adverse events when a drug is prescribed.

In today’s Federal Register, the FDA announced the availability of a guidance for industry entitled “Clinical Pharmacogenomics: Premarket Evaluation in Early- Phase Clinical Studies and Recommendations for Labeling.” This guidance is a revision of a previous guidance on this topic which was revised based on comments submitted to the FDA as well as the increased regulatory experience and evolution of the science of pharmacogenomics. The revised guidance describes when pharmacogenomics studies are warranted and further elaborates on targeted sample collection, sample retention, genotyping approaches, pooled analyses, dedicated prospective pharmacogenomics studies, genetic substudies and safety pharmacogenomics. This guidance is referenced in another recent draft guidance from the FDA, “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” recommending the use of genomics for the identification of a responder population which can enhance the benefit–risk relationship of a drug by avoiding exposure and potential toxicity in people who cannot benefit from the drug.

Nick Fleischer, R.Ph., Ph.D. is Vice President at  The Weinberg Group, the world’s leading food and drug consulting firm. If you have any questions or thoughts on this blog post or others, please contact us.