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Drug Benefits: Off-label Indication & Illegal Promotion

Gavel & Pestle Podcast host –Darshan Kulkarni, PharmD, MS, Esq – provides insight on Off-Label indication and illegal promotion of drugs. What […]

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February 09, 2017 Gavel & Pestle Podcast, Law of the Land

Gavel & Pestle Podcast host –Darshan Kulkarni, PharmD, MS, Esq – provides insight on Off-Label indication and illegal promotion of drugs. What you don’t know can get you thrown in jail or millions in fines.

Providing Coverage for Off-label Prescriptions
While off-label promotion is the purview of the Justice department, certain off-label prescribing is for all intents and purposes sanctioned by behemoth entities such as Medicare, and guided by national compendia. In 1993, a portion of the Omnibus Reconciliation Act legally required Medicare to cover an off-label use of a cancer drug if it is in the drug compendia, or is supported by peer-reviewed articles in certain journals outlined by Medicare.

References: BioWorld Perspectives

http://www.bioworld.com/content/label-use-fine-line-between-illegal-promotion-and-useful-information