Off-Label Drug Promotion: The False Claims Act and Anti-Kickback Statute

June 2012Articles Compliance Today
Physicians sometimes prescribe a drug or medical device for a use that has not been approved by the Food and Drug Administration, a so-called “off label” use. A great deal of focus has been placed on pharmaceutical manufacturers’ off-label promotion of drugs and the compliance issues confronting those manufacturers. Often absent from that discussion is any recognition of the compliance issues challenging the recipients of those promotional activities, specifically, the health care industry. Health care companies must be alert to the unique compliance questions facing them (e.g., preventing their employees from bowing to the pressure and accepting some form of remuneration in exchange for increasing the use of a particular drug—even when the drug may have been illicitly promoted for non-approved, off-label uses).

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