Pharmacogenomics and drug development: the impact of US FDA postapproval tracking on clinical pharmacology. (March 2008)

• Record Type: Journal Article
• Authors: Farrell, Erin; Usuka, Jonathan
• Is Part Of: Personalized medicine. Volume 5:Number 2(2008)
• Page Start: 133
• Page End: 139
• Publication Date: 2008-03
• Subjects: adverse drug reaction -- biomarker -- pharmacogenomics -- SNP -- US Congress -- US FDA -- Vioxx®®; Pharmacogenomics -- Periodicals; Pharmacogenetics -- Periodicals; 615.19
• DOI: 10.2217/17410541.5.2.133
• Languages: English
• ISSNs: 1741-0541

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.