FDA Guidance Seeks to Catch-Up to the Instagram and TikTok Era
The laws governing marketing prescription drugs have been well established for many years. Consumers are accustomed to hearing a slew of warnings and conditions at the end of a television commercial for a prescription drug or seeing the fine print at the bottom of a magazine advertisement. Often the disclaimer includes a note that the consumer should ask his/her doctor or medical provider if the drug is right for them. But in the digital age, marketing prescription drugs is much more than a commercial on television or a print ad. Social media and the use of influencers have completely changed the way consumers are introduced to prescription drugs, and the Food and Drug Administration (FDA) is trying to catch up to present day technology. This presents a dilemma nearly unique to the FDA, as the United States is only one of two countries (the other being New Zealand) that permit prescription drug marketing through social media.
Take, for example, the 2015 warning letter to Kim Kardashian regarding her Instagram post claiming a drug gave her relief from morning sickness, or the warning letter to her sister Khloe after her interview on talk show The View in 2021 was published to YouTube and made claims of a drug’s ability to aid in weight loss. The FDA’s concerns in both circumstances included issues that were not addressed by current guidance. Although Kim’s post included a URL to the company’s website, the website lacked required risk and benefit information. In Khloe’s situation, the casual nature of speaking with a talk show host about a range of lifestyle issues became an unintended advertisement.
The Kardashian sisters are not the only influencers considering drug advertising partnership opportunities today. The FDA last updated its guidance on marketing prescription drugs on social media in 2014—years before the Instagram platform became influencer driven and around the time TikTok came on the scene under a prior name. The guidance speaks mainly to the use of blogs and Facebook as the guidepost for marketing on social media platforms, leaving room for inconsistent interpretation and application from drug companies, marketing agencies, and influencers alike.
WHAT DOES THE CURRENT GUIDANCE SAY?
The FDA is responsible for the regulating prescription drug promotion under the Food, Drug, and Cosmetic Act. See 21 U.S.C. 352(n),(q)-(r).Under the current regulations drugmakers must present a fair balance of risk and benefit information to consumers. But uniquely, social media platforms limit the amount of space, time, and characters that can be used in a post or communication.
The 2014 draft guidance regarding social media marketing suggests drugmakers include: (1) risk information in the body of the communication, rather than just providing a link to the risk information; and (2) a link to a page with risk information only. When communicating the benefits of a prescription drug, an advertiser should: (1) ensure that the benefit information is accurate and non-misleading, and includes all material facts within each individual post; (2) ensure that the benefit information is accompanied by risk information within each post; and (3) reconsider using the social media platform if it cannot communicate all benefit and risk information adequately in one post. When disclosing the risks of a prescription drug, an advertiser should: (1) present risk information with benefit information in each post; (2) include in each post the most serious risks associated with the product, (3) use a mechanism like a hyperlink to allow direct access to a more complete discussion of risk information, and (4) ensure that the prominence of risk information is comparable to that of the benefit information. While the FDA has not issued any final guidance, it currently relies on this draft guidance and states that it represents the agency’s position on social media marketing at this time.
GAPS IN GUIDANCE FOR 2023 SOCIAL MEDIA
The current guidance only addresses “static” posts like those that were published then on blogs, Facebook, or Twitter. But, unlike a static Facebook post, an Instagram story can continue into multiple posts, include “swipe up” links, involve non-scripted and live video, and is limited to the amount of words that would fit on the initial screen. Moreover, since the guidance was published in 2014, all forms of social media have expanded to include video, including video that exists only for a brief period of time and is then deleted automatically. The nine-year-old guidance that currently governs advertisements clearly was not promulgated with an eye toward the interactive and versatile nature of today’s social media.
So what should a drugmaker do when the post is an Instagram story or TikTok video instead of a static post? Who is liable for the failure to comply with unclear guidance? How can third party marketing agencies insulate themselves from the uncertainty that occurs when contracting with influencers? How does the FDA account for the difficulties marketers face to monitor influencer posts that may be in video format and may exist for only 24 hours or even less? The guidance provides no clear answer.
WHAT IS THE FDA DOING ABOUT IT?
The FDA is clearly aware of the dangers of social media advertising today. In September 2022 it issued a notice cautioning consumers from engaging in trendy online challenges involving over the counter drugs. On the prescription drug front, in 2022 it commissioned four scientific studies of the health and safety impact of drug promotion on social media, to examine the effectiveness of (1) including substantive risk information in social media posts versus only providing a link to risk information and (2) including risks and benefits versus only risks on the linked landing page. The results of the research highlight the many tradeoffs of using landing pages to list risk information. Notably, the study showed that (1) including the risk in the post increased the likelihood that participants would recognize the risk after the first and second viewings; (2) after the second viewing, including the risk decreased the likelihood that participants would click the landing-page link, and decreased the number of landing-page-only risks recognized; and (3) including the drug’s benefit on the landing page increased benefit recognition without negatively affecting risk recognition or risk perceptions. FDA has not announced its next steps, but studies like this one often lead to new or updated rules or guidance.
BEST PRACTICES IN THE INTERIM
Until new guidance is issued, it is safest for companies to continue using static posts to promote prescription drugs. This will allow drug manufactures, marketing agencies, and influencers to work together to script compliant dialogue before finalizing a post. Another option is to submit marketing material to the FDA prior to posting. Although the FDA does not provide approvals for proposed advertisements, it will inform submitters that their submissions are noncompliant prior to issuing a warning letter or seeking other administrative action. The FDA created the pre-post submissions process to “provide opinions on proposed advertisements and labeling pieces before use.” Therefore, pre-post submissions can help demonstrate an advertiser’s desire to create compliant marketing material. Advertisers may also want to seek legal advice from an experienced attorney to assist with any innovative marketing ideas that are not already addressed by current guidance.