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Pharmacogenomics and drug development: the impact of US FDA postapproval tracking on clinical pharmacology
Erin Farrell1, Jonathan Usuka1
1Group Research Information, F Hoffmann-LaRoche Ltd, A5-4, 3431 Hillview Ave, Palo Alto, CA 94303, USA. jonathan.usuka@roche.com.
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.
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