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Off‐Label Use of Drugs and Medical Devices: A Review of Policy Implications
Author(s) -
Stafford R S
Publication year - 2012
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2012.22
Subject(s) - food and drug administration , clinical pharmacology , off label use , product (mathematics) , business , drug , medicine , pharmacology , health care , risk analysis (engineering) , political science , law , geometry , mathematics
“Off‐label use” occurs when the use of a medication or device deviates from what is mentioned in its US Food and Drug Administration (FDA) product label. Off‐label use is common, legal, and an important source of innovation; however, it can be costly, and strong evidence of the efficacy and safety of such use may be lacking. 1 Given the contradictory and unresolved expectations of major stakeholders, off‐label use remains problematic. It requires a new policy paradigm that can successfully balance the need for innovation against the imperatives of evidence‐based practice and finite health‐care resources. Clinical Pharmacology & Therapeutics (2012); 91 5, 920–925. doi: 10.1038/clpt.2012.22