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.
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.
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.
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.
