| | 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> |
| − | As of September 25, 2022, a total of 2,719 decisions (2,250 federal) have referenced the term "off-label". Of those, only 231 decisions (196 federal) discuss the FDA in proximity with the "off-label" term, and many of those cases are class action product liability cases. | + | As of September 25, 2022, a total of 2,719 decisions (2,250 federal) have referenced the term "off-label". Of those, only 231 decisions (196 federal) discuss the FDA in proximity with the "off-label" term, and many of those cases are class action product liability cases, qui tam actions under the [[False Claims Act]], and disputes over laws against promoting off-label uses. |