On November 7, 2016, the Food and Drug Administration (FDA) announced 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 move seems to be a step in line with the FDA’s plan to align drug promotion regulations with more modern communications technologies and platforms since releasing draft guidance in June 2014, “Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.”
When the FDA released the Social Media Guidance, it generated a significant amount of worry in the life sciences industry because it simply put the old rules for traditional communication platforms (i.e, print media, radio, and television) to the newer technologies (i.e., social media and other internet uses). Essentially, the Social Media Guidance required companies to include all relevant risk and benefit information in all internet promotions, even if that form of communication has character limitations. The FDA previously stated that the alternative is to not use the character space limited platforms to promote regulated products.
The FDA’s reasoning has long been questioned, 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.
The Proposed Studies
The announcement proposes four different studies to gather data on participants’ retention of risk information communicated through sponsored links and microblog posts. The four studies will present participants 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
The 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 in each study. Each participant will be presented with risk information either within the character-limited communication itself, or through a link provided in the communication. Second, each participant will then be instructed to either browse information about weight loss or migraine, or to perform directed searches for specific information.
It is the FDA’s belief 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.
The proposal is welcome, as the flow of information about FDA’s social media policies more or less stopped at the release of the June 2014 draft guidance. Only one OPDP letter issued in 2016 cited social media activity, leading to even further gaps and confusion.
If the studies support the FDA’s hypothesis, it is likely that the agency will not allow exceptions to the benefit/risk information requirement, even as communication and social media platform technology continues to evolve. However, if the studies show that risk information retention and perception of risk are statistically similar across some or all of the variables, the FDA will then be forced into reconsidering whether alternative methods of product risk communication may be acceptable.
If you have any comments on the proposed studies, you can go to regulations.gov, search for docket number FDA-2016-N-3585, and submit a comment electronically.