Digital platforms have revolutionized how information is disseminated to consumers. In the United States, the typical user spends approximately 2.5 hours on social media per day. Consequently, the pharmaceutical industry has increasingly turned to social media over print, television, or other traditional advertising channels to advertise their drug products. In 2021, the pharmaceutical industry spent nearly 14 billion dollars on digital advertising, and that figure is projected to reach nearly 20 billion by 2024.
The FDA’s Office of Prescription Drug Promotion (OPDP) regulates promotional speech of prescription drugs. In 2014, OPDP released two guidance documents related to social media advertising— one concerning how to present risk and benefit information on platforms with character or space limitations, and the other on how to correct independent third-party misinformation about prescription drugs and medical devices. These documents state that advertisements must be balanced— if companies decide to advertise benefits of their products on a platform with space or character limitations, they must also prominently incorporate risk information about their product within the same communication. Advertisements must also be accurate and not misleading.
These guidelines leave much to interpretation. To comply, companies must make value judgments as to what constitutes fair balance or a “prominent” presentation of risks. Some companies don’t provide risk information in the body of the advertisement at all, and opt to provide risk information on a linked landing page. This is concerning, as research suggests that a very small percentage of people actually click through the links on advertisements.
Additionally, these documents largely focus on “static” posts like those on traditional blogs, Twitter, and Facebook. In 2023, users are more commonly exposed to short form videos on Instagram and TikTok that incorporate dynamic and interactive features such as “swipe up” links and disappearing “stories” or video. The FDA has not made sufficiently clear how fair balance is achieved in these contexts. Is including risk information in the “swipe up” link sufficient? Is including risk information at the end of a long caption (where the user must tap to “open” to see the entire caption) “balanced” against the benefits more prominently displayed at the top? In addition to formalizing the 2014 guidance, the FDA should address these issues.
It is difficult to overstate the importance of regulating prescription drug promotion in the age of social media. Consumers are increasingly using social media platforms such as TikTok and Instagram to obtain health-related information. Even physicians are influenced by the marketing campaigns of social media. The original guidance on prescription drug advertising was drafted with traditional advertising in mind, in media such as print and television.1 The FDA has updated their guidance periodically since then, but to an inadequate degree. Social media has and continues to drastically change how patients consume information, and some manufacturers are willing to push the boundaries created by FDA’s outdated guidelines.
Of course, it is not feasible to expect the FDA to monitor every single post. However, given the rapidly changing landscape of social media and digital advertising, OPDP should provide guidance on this issue at a greater frequency than once per decade. The FDA could also create an advisory committee to implement periodic regulatory policy changes as the landscape continues to evolve. Lastly, while OPDP has commissioned several studies related to drug promotion on social media, they should continue to develop and implement a research agenda reflective of real-time issues and need. To do so, it is imperative that OPDP is adequately staffed with experts in not only medicine and pharmacology but also in behavioral research, particularly consumer behavior, and digital media. By conducting a more robust research agenda and working with experts, the FDA can and should address these questions formally for the ultimate benefit of patient health and safety.
[1] Peter Barton Hutt et. al., Food and Drug Law 1141-42 (5th ed. 2022).