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An '''off-label''' use of a drug means using an [[FDA]]-approved drug for an unapproved use. It is estimated that
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An '''off-label''' use of a drug means using an [[FDA]]-approved drug for an unapproved use.  
    
Estimates are that 21% of all prescriptions are off-label, and an even higher percentage of 36.2% of medications in intensive care units are off-label.  "One study estimated that 21 percent of drugs prescribed by office-based physicians were for off-label uses." See U.S. Gov't Accountability Office, Medicare Part D: Plan Sponsors' Processing and CMS Monitoring of Drug Coverage Requests Could be Improved, GAO 08-47, 15 n.26 (2008) (citing D. Radley, et. al., Off-Label Prescribing Among Office-Based Physicians, 166 Archives of Internal Med. (May 8, 2006))<ref>http://www.gao.gov/new.items/d0847.pdf.  Bailey v. Wyeth, Inc., 2008 N.J. Super. Unpub. LEXIS 3004, *19.</ref>
 
Estimates are that 21% of all prescriptions are off-label, and an even higher percentage of 36.2% of medications in intensive care units are off-label.  "One study estimated that 21 percent of drugs prescribed by office-based physicians were for off-label uses." See U.S. Gov't Accountability Office, Medicare Part D: Plan Sponsors' Processing and CMS Monitoring of Drug Coverage Requests Could be Improved, GAO 08-47, 15 n.26 (2008) (citing D. Radley, et. al., Off-Label Prescribing Among Office-Based Physicians, 166 Archives of Internal Med. (May 8, 2006))<ref>http://www.gao.gov/new.items/d0847.pdf.  Bailey v. Wyeth, Inc., 2008 N.J. Super. Unpub. LEXIS 3004, *19.</ref>
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