When one thinks of FDA’s Office of Prescription Drug Promotion (OPDP) there is a likely tendency to think of the regulatory action letters – Warning Letters or Untitled Letters -issued by that office to pharmaceutical companies about their promotional communications.
But there is another activity in which OPDP is highly engaged – one which informs that process – research. Each year OPDP executes a research agenda and publishes the results of the studies that it undertakes. And prior to engaging in research, the agency posts in the Federal Register a notice about each effort, soliciting input and comment from stakeholders.
The aim of the research efforts is of course centered on some shedding evidence-based light on various aspects of promotional language, formats and practices in pharmaceutical marketing. The goal is to provide a body of research by which FDA can assess the impact of promotion on the perceptions among target audiences with particular respect to understanding benefits and risks associated with a medicine.
But despite the mass migration by the consumers of healthcare information into digital information – along with the fact that increasing numbers of viewers are streaming away from commercial television, FDA’s OPDP – very late to the grasping the impacts of digital on communications overall – has mainly kept its research focus on the examination of very traditional communications vehicles. This has most particularly focused on Direct-to-Consumer (DTC) advertising on television. For example, in the “Completed Research” section of the OPDP site, some of the most recent projects completed in 2018 include
- Market Claims in DTC Prescription Drug Print Ads
- Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in DTC Prescription Drug Ads
- Hearing, Aging, and DTC Television Ads
- Content Analysis of Accelerated Approval Prescription Drug Direct-to-Consumer Websites
But there is an important exception to the largely DTC focus in the current line up. Of the one dozen projects listed in the Research in Progress category is one that stands out – Character Space Limited Online Prescription Drug Communications. This research is to examine fair balance presentation in the confined space of Twitter (without saying Twitter) and other space-confined venues. In 2017, FDA published results from some very limited research on the promotion of prescription drugs on mobile devices.
Digital and social media has been a particular challenge for OPDP for a long time and there has never been a complete response to the framework of questions posed by the agency in the initial public hearing that was called to inform guidance development in this important area. The issue of character space limitation is an important one, not only because of the ubiquitous use of platforms like Twitter. Rather, space limitation also applies to small screens – such as mobile phones (not being addressed in this research). In 2014, five years after the initial public meeting on regulating digital and social media, FDA did issue a guidance document “Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices” that provided a construct for how companies might address risk information presentation when benefit claims are made. The new research will take a closer look. According to OPDP’s description, the research project “is designed to address the question of whether substantive risk information in the character-space-limited communications is effective in communicating risks when benefit claims are made, or whether a link to the risk information is sufficient.”
OPDP states that they will manipulate various scenarios to assess ability to include sufficient risk information in the context of a link. This is one to watch closely. While branded twitter feeds are not all that common, and product benefit mentions rare if not non-existent in that setting, the findings from the research project should be informative of how the office intends to respond, not only on twitter, but perhaps even in the context of a site that has been optimized for mobile viewing. And given the lack of specificity on digital by the agency, we have take any tea leaves we can get.