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Evidence of Pharmaceutical Innovation and Therapeutic Enthusiasm

Evidence of Pharmaceutical Innovation and Therapeutic Enthusiasm EDITORIAL HEALTH CARE REFORM Evidence of Pharmaceutical Innovation and Therapeutic Enthusiasm Strategies for Patent Extension N THIS ISSUE OF THE ARCHIVES,DOWNING ET AL gest that manufacturers who seek approval for a new for- present a case report about how a pharmaceu- mulation or dose of an approved drug should first be tical manufacturer successfully avoided ge- required to resolve outstanding patent infringement law- neric competition for one of its blockbuster drugs suits. Laws might be rewritten to permit generic switch- I for more than a decade. The use of patent in- ing at bioequivalent doses. Patients and payers can chal- fringement lawsuits to delay generic competition, a prac- lenge the high price of trade drugs when generics are tice called “evergreening,” is common and perhaps well available, and physicians can take responsibility for pre- known. scribing clinically meaningful treatments. In other words, the success of Abbott’s fenofibrate did not depend solely on novel methods of avoiding generic substitutions: it See also page 724 required tacit acceptance among the manufacturer and payers, patients and physicians, professional societies and However, for fenofibrate, Abbott Laboratories devised guideline committees. a novel and especially clever approach: the manufacturer Therapeutic enthusiasm for lipid-lowering treat- reformulated http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Internal Medicine American Medical Association

Evidence of Pharmaceutical Innovation and Therapeutic Enthusiasm

JAMA Internal Medicine , Volume 172 (9) – May 14, 2012

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Publisher
American Medical Association
Copyright
Copyright 2012 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
2168-6106
eISSN
2168-6114
DOI
10.1001/archinternmed.2012.382
pmid
22493408
Publisher site
See Article on Publisher Site

Abstract

EDITORIAL HEALTH CARE REFORM Evidence of Pharmaceutical Innovation and Therapeutic Enthusiasm Strategies for Patent Extension N THIS ISSUE OF THE ARCHIVES,DOWNING ET AL gest that manufacturers who seek approval for a new for- present a case report about how a pharmaceu- mulation or dose of an approved drug should first be tical manufacturer successfully avoided ge- required to resolve outstanding patent infringement law- neric competition for one of its blockbuster drugs suits. Laws might be rewritten to permit generic switch- I for more than a decade. The use of patent in- ing at bioequivalent doses. Patients and payers can chal- fringement lawsuits to delay generic competition, a prac- lenge the high price of trade drugs when generics are tice called “evergreening,” is common and perhaps well available, and physicians can take responsibility for pre- known. scribing clinically meaningful treatments. In other words, the success of Abbott’s fenofibrate did not depend solely on novel methods of avoiding generic substitutions: it See also page 724 required tacit acceptance among the manufacturer and payers, patients and physicians, professional societies and However, for fenofibrate, Abbott Laboratories devised guideline committees. a novel and especially clever approach: the manufacturer Therapeutic enthusiasm for lipid-lowering treat- reformulated

Journal

JAMA Internal MedicineAmerican Medical Association

Published: May 14, 2012

References