FDA safety warnings and trends in testosterone marketing to physicians.

Abstract

In response to study findings showing the risk of cardiovascular adverse events associated with testosterone therapy, the FDA issued safety warnings in 2014 and modified testosterone labeling in March 2015 to indicate the increased risk of stroke and heart attack. It is unknown whether there were changes in testosterone marketing practices by pharmaceutical companies following the FDA label warning. Both primary care physicians (PCPs) and non-PCPs prescribe testosterone and are targeted by pharmaceutical marketing representatives to encourage testosterone prescribing. Likewise, pharmaceutical marketing occurs in both urban and rural areas. Our study is the first to examine testosterone marketing practices around the period of the testosterone label warning by physician specialty and rural vs urban primary care service area. In this study, we found that testosterone marketing efforts such as marketing spending per encounter, quarterly marketing spending per physician, and quarterly number of encounters per physician increased among non-PCPs and urban physicians for 4 quarters following an FDA boxed warning in 2015 on testosterone prescriptions. After the black box warning, off-label testosterone advertisements stopped. This reduction in advertising could have made it more attractive for pharmaceutical companies to increase their marketing spending targeting non-PCPs and physicians in urban areas. Understanding responses of pharmaceutical companies to FDA guidelines is important and can help inform future guideline initiatives.