Off-label

An off-label use of a drug means using an FDA-approved drug for an unapproved use. It is estimated that

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))

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.

Background

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e) Off-Label Use The FDA policy of regulating drugs and not the practice of medicine has been consistent since the creation of the agency in 1983 by the enactment of the FDCA. This policy was noted by the FDA at the 1991 advisory committee. See Advisory Committees, infra, III(f). "The FDA's job and legal mandate is not to regulate the practice of medicine but simply to regulate the availability of medications to the practicing population at large." Transcript of Fertility and Maternal Health Drugs Advisory Committee, meeting, 46:17-20 (June 20, 1991). Allowing physicians to prescribe for off-label use "is an accepted and necessary corollary of the FDA's mission to regulate in this area without directly interfering with the practice of medicine." Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 350, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2001) (discussing FDA regulation of medical devices). Off-label activity has been defined by the FDA as a "use for indication, dosage form, dose regimen, population or other use parameter not mentioned in the approved labeling." Janet Woodcock, M.D., A Shift In The Regulatory Approach, PowerPoint, at slide 3 (June 23, 1997) at http://www.fda.gov/cder/present/diamontreal/regappr/sld003.htm) (last visited July 3, 2008). Off-label prescribing of drugs is both legal and ethical. The New Jersey Legislature declared "'off-label' use of an FDA-approved drug [to be] legal when prescribed in a medically appropriate way." N.J.S.A. 26:1A-36.9(e). The FDA has long acknowledged that undue restrictions on off-label use could have adverse health consequences. In 1982, the FDA Drug Bulletin informed the medical community that "[o]nce a [drug] product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling." 12 FDA Drug Bulletin 4, 5 (1982). The agency went on to state that 'unapproved' or more precisely 'unlabeled' uses may be appropriate and rational in certain circumstances, and may, in fact reflect approaches to drug therapy that have been extensively reported in medical literature .. . Valid new uses for drugs already on the market are often first discovered through serendipitous observations and therapeutic innovations. [Id. at 5.] Following the accepted medical standard of care, physicians frequently prescribe drugs for off-label or unapproved uses.

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Bailey v. Wyeth, Inc., 2008 N.J. Super. Unpub. LEXIS 3004, *17-19.

"even the FDA has acknowledged that off-label use of a drug may be appropriate and rational (see Use of Approved Drugs for Unlabeled Indicators, FDA Drug Bulletin (Public Health Service, Md.) April 1982, vol. 12, No. 1, 4-5)." Proctor v. Davis, 291 Ill. App. 3d 265, 295, 225 Ill. Dec. 126, 146, 682 N.E.2d 1203, 1223 (1997) (dissent).