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Off‑label use is the practice of prescribing a medication or using a medical device for a purpose other than that for which the medication or device is officially approved.  In the United States, off‑label use is legal and extremely common.  According to one recent study, over one‑fifth of all drugs are prescribed off‑label.¹  For cardiac medications, off‑label use is estimated at 46 percent.²  Other studies have indicated that the majority of cancer drug treatment is off-label³ and that 81 percent of AIDS patients are prescribed drugs off-label.⁴

But although off‑label use is legal, most types of off‑label promotion are prohibited.  The federal Food and Drug Administration (“FDA”) generally forbids manufacturers from marketing drugs and medical devices for unapproved uses.  The FDA does allow manufacturers to provide physicians with scientific and educational information about off‑label uses, but such information must comply with strict FDA guidelines.  Manufacturers engaging in illegal off‑label promotion can face enormous monetary and reputation damages, both from governmental actions and private law suits.

Part One of this white paper reviews current law and regulation with respect to off‑label marketing.  Part Two examines the potential liability that can result from off‑label promotion.  Finally, Part Three discusses best practices to manage the risks of off‑label activities.

¹ See Radley et al., Off‑label Prescribing Among Office‑Based Physicians, 166 Arch. Intern. Med. 1021 (2006).
² Ibid.
³ Woodside, Drug Product Liability (2009) § 8B.02.
⁴ “Patients Take Off-Label Drugs for Opportunistic Infections,” AIDS Weekly (Oct. 24, 1994.)