The changing landscape of off-label prescription drug promotion: Opportunities to improve decision-making

Abstract

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.

Citation

Sarkees, M.E. and Fitzgerald, M.P. (2016), "The changing landscape of off-label prescription drug promotion: Opportunities to improve decision-making", International Journal of Pharmaceutical and Healthcare Marketing, Vol. 10 No. 2, pp. 148-160. https://doi.org/10.1108/IJPHM-08-2015-0042