How personalized medicine is changing the rules of drug life exclusivity.
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.
Sullivan
Clark G
CG
King & Spalding LLP, 191 Peachtree St, Atlanta, GA 30303, USA. csullivan@kslaw.com
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
D016568:Drugs, Generic