On Oct. 31, 2016, the FDA issued a Notice on its intent to conduct studies into the topic of “Character-Space-Limited Online Prescription Drug Communications.” The studies seek to find out “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.” (See simplified visual of the study design below.) The deadline to submit comments to the FDA was Jan. 6, 2017.

Intouch invited clients and colleagues to weigh in on this important matter for the Industry. We also partnered with Kulkarni Law, a firm specializing in pharmaceutical advertising compliance and other regulatory concerns. Together, we articulated our opinions on the proposed studies into one document and submitted them to the FDA along with 10 other commenters.

Following is an overview of our response and highlights from other responses submitted to the FDA.

Intouch Solutions-Kulkarni Response Highlights
Intouch experts and partners reviewed the study design in detail and also obtained and reviewed a copy of the study questionnaire. Our response focused on optimizing the proposed study design and stimuli. Recommendations included:

  • Removing extraneous variables from the study stimuli and making questionnaire instructions clearer and more likely to elicit user engagement with the content presented
  • Applying design best practices to the landing pages that included Important Safety Information to ensure they’re easily read and understood by study participants
  • Making hypothetical ads more engaging through stronger calls to action and leveraging typographical treatments and other available methods for calling out safety language in those ads that provide risk information within character-space-limited communications
  • Using responsive-design methodology to enable study participants to browse the study stimuli within their preferred devices and browsers, so as to replicate their real-life browsing behaviors as closely as possible

Overall, Intouch supports the effort to study the effects of communicating risk information within character-space-limited ad formats vs. via a link to a landing page with the Important Safety Information. This study may present an opportunity for the FDA to revisit its position on the One-Click Rule and open up more opportunities for marketers to engage with consumers.

However, we also expressed our concern with the study as it’s currently proposed, in that it may not adequately reflect consumers’ current online behaviors and digital best practices.

Different Voices, United Themes
A range of entities submitted comments to the FDA, including:

  • Pharmaceutical industry: AbbVie, Eli Lilly and Pharmaceutical Research and Manufacturers of America (PhRMA)
  • Digital communications industry groups: Interactive Advertising Bureau (IAB), Digital Health Coalition (DHC)
  • Life-sciences-focused marketing agencies: Intouch Solutions, LiveWorld, Klick
  • Private individuals

Responses from members of the Industry had several uniting themes:

  • Belief that prescription drug communications have a beneficial impact on public health and that the pharmaceutical industry has an important role to play in engaging in those communications within search and social spaces – especially to combat health misinformation published by entities not regulated by the FDA
  • Concern that the study as proposed does not reflect the reality of prescription drug communications within character-space-limited formats and the behaviors of patients consuming health information
  • Suggestions that the FDA consider the full range of communication methods afforded by these platforms, such as Twitter cards, images, videos, etc.

Key Takeaways
Overall, the industry appeared aligned about the need to be able to engage with consumers on the platforms they use to search for and discuss health information. However, the proposed study would need to be modified in multiple ways in order to fairly represent realistic conditions and to have practical utility.

Our Commitment: Providing Truthful, Balanced Content
Intouch will continue to pursue critical opportunities to engage with the FDA on matters affecting our clients’ ability to communicate with their customers in the digital channel. We believe the missions of the FDA and pharmaceutical industry intersect at a crucial point in patients’ journeys toward better health. We therefore consider it a matter of utmost importance to continue exploring methods of communicating health information in the ways that most effectively convey truthful and balanced content.The FDA’s current position on the One-Click Rule within character-space-limited platforms is a significant obstacle in providing such communications at the time and place where patients are looking for and discussing health information. We support every effort to study the benefit-risk communication in these platforms as the way to further our collective understanding of patient needs and how the industry can best serve them in the way that ultimately helps improve health outcomes.

Download a PDF of our complete submission, or our Industry Brief, for more information.