It's Time to Shine the Light on Direct-to-Consumer Advertising

Abstract

Pharmaceutical marketing is undergoing a transition as the business, delivery, and consumption of health care have increasingly become part of a growing digital landscape. Changes in pharmaceutical promotion also coincide with federal "sunshine" regulations newly implemented under the Affordable Care Act that require disclosure of certain marketing and industry payments to physicians. Collectively, these trends could lead to fundamental shifts in physician-directed and direct-to-consumer advertising (DTCA) that have yet to be adequately identified or explored. In response, we advocate for greater DTCA transparency, especially in the emerging digital forms of DTCA, to complement forthcoming sunshine transparency data. This will allow more robust study and understanding of changes in overall pharmaceutical marketing trends and their impact on health care consumption and behavior. This can also lead to more targeted state and federal policy interventions leveraging existing federal transparency regulations to ensure appropriate marketing, sales, and consumption of pharmaceutical products. BACKGROUND Over the past few decades, US pharmaceutical marketing has evolved in new and unexpected ways, as the business of health care has become part of a growing "eHealth" landscape. Increasingly, patients and other consumers, clinicians, and the industry have started to embrace emerging forms of digital technology (eg, the "health Internet," mobile health applications, self-tracking devices, and social media) that can influence health care information sourcing, consumption, and delivery. As an indication of this shift to "all things digital," the Pew Research Internet Project reports that 72% of surveyed US adults looked for health information online within the past year, 69% track at least 1 health indicator such as weight, exercise, symptoms, blood pressure, or sleeping patterns (with 21% of respondents using a form of technology to do so), and 52% of smartphone users use their devices to search for medical/health information. 1With consumers increasingly using information technology to deal with health issues, and with pharmaceutical manufacturers using directto-consumer advertising (DTCA) on the Internet, in social media, and through mobile applications (collectively "eDTCA"), [3][4][5][6] traditionally dominant forms of pharmaceutical marketing, which include physician-directed promotion and advertising in traditional media (eg, television, radio, print, and outdoor advertisements) might also be changing. 8 This led to a proliferation of drug advertisements on TV and in print to which the vast majority of Americans were exposed, likely prompting patients to request a promoted drug from their physician. 9,10 After hitting a peak of $5.89 billion in 2006, DTCA began to decline, with spending estimated to be $4.37 billion in 2010. This decrease has largely been attributed to dwindling drug pipelines, blockbuster patent expirations, and the recent global economic slowdown, 11-13 although certain subcategories (eg, t...

Digital Direct-to-Consumer Advertising: A Perfect Storm of Rapid Evolution and Stagnant Regulation Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters"

“…13 Yet this marketing medium remains highly controversial given the rising costs of prescription drugs, a point underscored by a recent vote by the American Medical Association in support of a DTCA ban. 39 Despite eDTCA's rapid growth and maturation, regulatory responses seem to be several steps behind industry activities, who can no longer afford to wait for FDA to give them sufficient guidance on how to engage with their patients online.…”

“…11 This means that continued growth in US national prescription drug spending will likely fuel further spending on DTCA, especially given increased scrutiny to physician-directed promotion due to transparency requirements enacted as part of the ACA. 6,12,13 Within the overall category of DTCA, a recent study found that Internetbased DTCA was the only subcategory that experienced rapid growth (an estimated 109% increase) from [2005][2006][2007][2008][2009]. 2 Yet, the ascendance of eDTCA should come as no surprise, with surveys conducted by the Pew Research Center showing that 72% of Internet users actively search for health information online.…”

Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: Teaching Drug Marketers How to Inform Better or Spin Better? Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters"

“…Nevertheless, given that DTCA is legally permissible in the United States and it is unlikely that this will be reversed, Kim's recommendation for more comprehensive guidelines for online prescription drug promotion needs to be heeded. The increasing pervasiveness of digital communication will mean drug marketers will continue to adopt innovative e-DTCA tactics 12 and guidelines must be flexible enough to keep abreast of and adequately account for developments in online drug promotion. For this to be achieved, more will need to be known about how pharmaceutical companies are adapting DTCA to the online environment.…”

“…For this to be achieved, more will need to be known about how pharmaceutical companies are adapting DTCA to the online environment. As Mackey and Liang 12 have noted, here lies the most urgent challenge in ensuring that DTCA is more productive than problematic, compelling pharmaceutical companies to be more transparent about what they are doing and spending when 'informing' consumers.…”

In This Issue: Policy and Practice

“…13 An essay identifies potential impending shifts in both physician-directed and direct-to-consumer advertising due to new federal "Sunshine" regulations that require disclosure of certain marketing and industry payments to physicians. 14 This issue contains a disquieting study that delineates the limited availability of physicians in rural areas who can prescribe buprenorphine for opioid use disorder. 15 The study addresses issues of rural health care delivery, opioid addiction, and creating a rational and effective health care workforce, that have been addressed with rigor and perspective over many years by the lead author, Roger Rosenblatt.…”