title: How personalized medicine is changing the rules of drug life exclusivity.
abstract: Personalized medicine is premised on the notion that diagnostic techniques can improve safety or effectiveness of pharmaceutical therapies based upon individual genetic or proteomic make-ups. This article explains how diagnostic techniques and pharmaceutical therapies interact during the US Food & Drug Administration's approval of branded and generic drugs in the US, and how the same labeling requirement for generic drugs of the Hatch-Waxman Act can prevent generic drugs from entering the market when proprietary pharmacogenomic techniques are incorporated into the labeling of a branded drug.
authors.affiliation: King & Spalding LLP, 191 Peachtree St, Atlanta, GA 30303, USA. csullivan@kslaw.com
authors.forename: Clark G
authors.initials: CG
authors.lastname: Sullivan
mesh_terms: D016568:Drugs, Generic / Q000191:economics / Q000627:therapeutic use*; D006801:Humans; D007206:Individuality; D025202:Molecular Diagnostic Techniques / Q000191:economics / Q000639:trends*; D010597:Pharmacogenetics / Q000191:economics / Q000331:legislation & jurisprudence / Q000379:methods*; D010817:Physician-Patient Relations; D014481:United States
chemical_list: D016568:Drugs, Generic