On November 7, 2016, FDA announced in the Federal Register its plan to research methods for including risk information about pharmaceutical and medical device products in promotional Internet communications that have character space limitations, such as sponsored links and microblogs. This appears to be the latest step in FDA's plan to align drug promotion regulations with modern (or at least recently modern) communications technologies and platforms since releasing the draft guidance, Internet/Social Media Platforms with Character Space Limitations--Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (the "Social Media Guidance") in June 2014.
Confusion Surrounds the Social Media Guidance
FDA generated a significant amount of consternation in the life sciences industry when it released the Social Media Guidance because the Agency merely fitted the old rules for traditional communication platforms (e.g., print media, radio, and television) to newer technologies (e.g., the Internet and social media). The Social Media Guidance boiled FDA's position down to three main elements:
- "Benefit information should be accurate and non-misleading and reveal material facts within each individual character-space-limited communication (e.g., each individual message or tweet)."
- "Benefit information should be accompanied by risk information within each individual character-space-limited communication."
- "If a firm concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same character-space-limited communication, then the firm should reconsider using that platform for the intended promotional message."
Essentially, the draft guidance requires companies to include all relevant benefit and risk information in all Internet promotions, even if that communication has character limitations. The alternative according to FDA is don't use character space limited platforms to promote regulated products.
FDA's reasoning behind the procrustean solution of including all risk information in the primary communication has drawn many questions from the industry since links to the complete product risk information can be more easily included in shorter communications. FDA did mention links to "a more complete discussion of risk information about the product" in the Social Media Guidance, but only as an additional element to a promotional communication that includes full benefit and risk information.
FDA's Proposed Studies
FDA's announcement proposes four studies to gather data on participants' retention of risk information communicated through sponsored links and microblog posts. The four studies will present participant with different promotional communications about two fictional drugs:
- A sponsored link to a fictional weight loss drug embedded in Google search results related to weight loss
- A sponsored link to a fictional migraine drug embedded in Google search results related to migraine
- A promotional tweet for a fictional weight loss drug embedded in a Twitter search page related to weight loss
- A promotional tweet for a fictional migraine drug embedded in a Twitter search page related to migraine
In each study, FDA will tailor the promotional communication and participant instructions to gather data on circumstances that may affect the user's retention of provided risk information. First, each participant will be presented risk information either in the character-space-limited communication itself (i.e., in the sponsored link or tweet) or through a link provided in the communication. Second, each participant will be instructed either to browse information about weight loss or migraine or to perform directed searches for specific information.
FDA hypothesizes that in each case, users will be more likely to retain risk information and have a greater sense of relevant risks when the risks are presented within the primary promotional communication and when users are searching for specific information about conditions or treatments.
Given FDA's current focus on generating supportive data for policy positions, it is no surprise that the Agency has proposed studies to bolster its general stance on promotional communications that manufacturers must include all benefit and risk information in promotional communications of any type. And FDA's study proposal is a welcome change because the flow of information about FDA's social media policies essentially stopped at the release of the draft guidance. Indeed, OPDP, FDA's primary watchdog on promotional activities, has only released four untitled letters and one warning letter in 2016, and only one of those letters cited social media activity.
If the studies support FDA's theory, we can expect that the Agency will not allow exceptions to the benefit/risk information requirement, even as communication and social media platform technology evolves. However, if the studies show that risk information retention and perception of risk are statistically similar across some or all of the variables described above, then FDA will be forced to reconsider whether alternative methods of product risk communication might be acceptable. Either way, FDA's proposed studies will increase transparency on the rationale for FDA's position on social media promotions.
If you would like to comment on FDA's proposed studies, you can go to Docket# FDA-2016-N-3585 on Regulations.gov and submit a comment electronically.