TY - JOUR AB - Purpose Off-label drug prescribing by healthcare providers is a growing practice. Yet, the US Food and Drug Administration bans the marketing of drugs for off-label uses. In recent years, legal challenges by the pharmaceutical industry have chipped away government restrictions on off-label drug promotion. Although the changing legal landscape has been discussed, this paper aims to examine how key stakeholders and policy-makers might interact to provide a more transparent marketing environment for off-label drug discussions in the patient–provider relationship.Design/methodology/approach Drawing on a variety of sources, the authors assess the current marketing landscape of off-label drugs and some of the issues that challenge the healthcare provider–patient relationship. The authors then examine opportunities to improve the off-label promotion environment and the relevant decision-making theories that key stakeholders need to consider when formulating marketing efforts and policies.Findings The authors suggest that fewer restrictions on truthful, non-misleading off-label drug promotion provide an opportunity to improve drug knowledge and, importantly, healthcare provider and consumer decision-making. Key stakeholders should consider, among other solutions, criteria for defining truthful information on off-label drugs, alternative methods of approval of off-label uses and ubiquitous icons to identify off-label prescribing to all stakeholders.Originality/value Rather than rehash the legal landscape of off-label drug promotion, this paper focuses on how the healthcare provider–patient relationship is impacted and how stakeholders can improve information flow in this changing environment. VL - 10 IS - 2 SN - 1750-6123 DO - 10.1108/IJPHM-08-2015-0042 UR - https://doi.org/10.1108/IJPHM-08-2015-0042 AU - Sarkees Matthew E. AU - Fitzgerald M. Paula PY - 2016 Y1 - 2016/01/01 TI - The changing landscape of off-label prescription drug promotion: Opportunities to improve decision-making T2 - International Journal of Pharmaceutical and Healthcare Marketing PB - Emerald Group Publishing Limited SP - 148 EP - 160 Y2 - 2024/04/25 ER -