Pharmacogenomics and Drug Development: the Impact of US FDA Postapproval Tracking on Clinical Pharmacology

Abstract

Severe adverse drug reactions to commonly prescribed drugs such as Vioxx have led to a call for increased scrutiny in deciding which patients are given which drugs, and how much drug they should receive. A personalized approach to medicine offers a larger variety of drugs and doses that would be prescribed only to a subgroup of patients. Pharmacogenomics could help divide patients into these subgroups based on variation in the genes either causing the disease or encoding the principle drug-metabolizing enzymes. Given the cost and infrastructure associated with assembling genetic data, drug sponsors, regulatory agencies and clinicians each play a role in the collection, storage and oversight of pharmacogenetic information. The 110th Congress is in the process of making changes to the drug-approval process and the role of genetics in that process.