Generation Patient is a nonprofit organization created by and for young adult patients—i.e., young adults with chronic medical conditions such as lupus, inflammatory bowel disease, Lyme disease, rheumatoid arthritis, and more. As young adults, we are at a pivotal life stage: navigating the transition to adulthood while simultaneously managing unpredictable health conditions and our personal, educational, professional, and psychosocial needs. To address our community's unique challenges, Generation Patient provides peer-support programming and drives systemic change through policy work, leadership programming, and evidence generation. We aim to amplify young adult patient voices in critical conversations where real change can occur. Through this strategy, we envision a future where young adults with chronic medical conditions can live with greater quality of life, access, dignity, and fulfillment.
As an organization, we do not accept funding from private healthcare, including pharmaceutical and insurance industries. We are guided entirely by the lived experiences of young adult patients, including this community-drafted comment.
Today’s young adult patients face unprecedented misinformation, disinformation, and misleading content. While some come from influencers without direct financial ties to the industry, we are particularly concerned about the misleading information driven by industry-supported messaging. To address this, we urge the FDA and industry leaders to collaborate with young adult patients, ensuring that information is shared with integrity and accuracy.
We are deeply concerned by misinformation from influencers and micro-influencers over the past few years, especially with the popularity of platforms like TikTok. Earlier this year, we published an article in STAT News emphasizing the need for the FDA to collaborate with the FTC. The FTC regularly issues endorsement guidelines, and direct coordination between the two agencies could lead to more relevant and timely updates to combat misinformation and disinformation.
These updates are long overdue—current guidelines were released over a decade ago when many of us were in middle or high school. Now, as young adults, we are witnessing a dramatic increase in online influence, leaving patients exposed to a constant stream of misleading information. While we appreciate the additional details in the recent guidance, it’s important to note that these guidelines are not legally binding for the industry. We believe there is an urgent need for stronger enforcement of industry accountability, particularly when direct financial ties are involved.
Instances of the FDA’s attempts to combat misinformation have been cited in the guidance, but more needs to be done, particularly in developing and promoting comprehensive resources. For instance, despite being active in combating misinformation, many of us were unaware of tools like the Rumor Control website, and we believe such platforms fail to effectively reach our demographic. We strongly recommend the FDA collaborate with young adult patients to develop more relevant and accessible sources of information. Rather than telling young people what to think, we recommend that the FDA focus on creating resources to educate our generation on how to think about information online. This process creates more trust, especially since, in many cases, misinformation is not straightforward.
We also recommend Commissioner Califf and other FDA representatives speak to the broader public more frequently. Conferences cited in the guidance, such as FDLI, do not reach communities like ours. Moreover, these conferences are often prohibitively expensive, making them inaccessible to members of the public who may want to attend. More authentic and accessible efforts to reach the public are urgently needed.
Additionally, our community of young adult patients would appreciate further additions or clarifications on several aspects of the guidance:
Clarify the meaning of “Independent Third Party”: For example, does "independent third party" include entities with any past or present financial relationship with the manufacturer, even if that relationship is unrelated to the ad or post in question?
Directly Address Micro-Interactions: The guidance lacks clarity on how misinformation spread through comment sections, direct messages, or other micro-interactions between influencers and followers should be handled. These exchanges, as identified by our community of young adults with chronic medical conditions, are often the most impactful and misleading. We recommend addressing the speed of dissemination of the advertisements (“virality”). We’ve seen ads with misinformation rack up millions and millions of views thanks to their virality; ignoring that factor is a big missed opportunity.
Clarify Applicable Organizations and Individuals: The guidance needs to be more specific on the types of organizations and individuals subject to these regulations. Both organizations and paid individuals must be held to the same standards of accountability when sharing false or misleading information. Without clear guidelines, paid promoters may evade the scrutiny that larger organizations face.
Provide Data on the Benefits of FDA Actions: While the FDA has outlined its actions to combat misinformation, data on the effectiveness of these efforts needs to be included. For example, resources are spent on initiatives like the FDA’s Rumor Control, but we need to know if they are making a measurable impact or if resources could be better allocated.
How is “Widespread Misinformation” Measured? If a firm has to, at minimum, identify at least one communication, how is the rest of the harmful misinformation dealt with? Which party is responsible for that? “When a firm identifies widespread misinformation, the firm should, at a minimum, clearly identify at least one internet-based, independent third-party communication that contains the misinformation the firm is addressing. For example, a firm might do this by noting the date and specific location within the internet-based setting where the independent third-party communication was posted. A firm can also note that the identified misinformation appears on other social media platforms” (p 14).
We believe that “applicable FDA labeling/advertising requirements” cover this, but we would want to ensure that if firms enlist the help of an influencer to convey the firm’s message, it is clearly indicated as an advertisement on social media and to disclose by whom they are being paid to say what they are. “That might include, for example, enlisting the help of HCPs through promotional communications directed to that audience; reaching the general public through a TV advertising campaign; enlisting an influencer to convey the firm’s message in internet-based settings; or any combination of these techniques. If the resulting promotional communication is consistent with applicable FDA labeling/advertising requirements, there are no special considerations created by the fact that the promotional communication addresses misinformation” (p 19).
We recommend clarity on the following section by answering these questions: “Are influencers or other personalities paid to make statements like that? If so, how is that disclosed? Who creates and publishes “help-seeking” communications?” “Finally, communications, sometimes characterized as help-seeking or institutional, represent another option firms have to address misinformation. These are communications that (1) do not name any specific medical product or make representations or suggestions that are associated with a specific medical product and (2) are separate and distinct from promotional communications about any specific approved/cleared medical product. Such communications are often used to provide information to raise awareness about diseases or general classes of available treatments. This information may be helpful in addressing false, inaccurate, or misleading information on these topics.”
We commend the wording here, on page 17: “FDA recommends that when firms choose to voluntarily address misinformation, they prioritize (1) misinformation that has current relevance (e.g., misinformation that is trending or actively spreading on internet-based platforms) and (2) misinformation that is being spread by independent third parties that have large follower bases or hold positions of trust because those users may have a wider range or a higher degree of influence. For example, a post by a social media personality with a large follower count will generally reach a broader group of users compared to a user with a small follower count.”
We are concerned that the guidance excludes television and radio advertisements, even when those ads are distributed, such as through streaming services. TV ads often feature celebrities promoting medical products, and many of these celebrities also use their social media platforms to push the same products. This creates a crossover between TV and social media that amplifies misinformation, yet TV ads are notably excluded from this guidance. We believe this omission overlooks a critical component of how misinformation spreads, particularly given the role of celebrity endorsements in both mediums.
We would like to reiterate that developing pathways for misinformation education cannot be done without the people most impacted being involved in direct development, especially those voices and experiences independent of private healthcare industry funding. We greatly look forward to supporting the FDA’s efforts through our collective and deeply informed young adult patient community. Thank you for including our perspectives in the finalization of this guidance.
Sincerely,
Sneha Dave
Executive Director
Generation Patient
Sydney Reed
Director of Operations
Generation Patient
Rosa Kelekian, MSW
Program Manager
Generation Patient
Casey Doherty
2024 Health Policy Scholar
Generation Patient
Peyton Miles
2024 Health Policy Scholar
Generation Patient
Correspondences can be directed to admin@generationpatient.org.
