The FDA’s updated guidance on online prescription drug misinformation, titled “Addressing Misinformation About Medical Devices and Prescription Drugs,” is a welcome first step in tackling the dangerous and under-regulated world of direct-to-consumer marketing of pharmaceutical products. However, this guidance alone is not nearly enough to address this serious problem.

To really protect patients from the harm of misinformation, the FDA’s guidance needs to better account for the unique features of social media and the agency needs to prepare actions to actually enforce its guidance.

Generation Patient recommends five immediate steps the FDA can take to bolster its guidance:

Provide greater clarity on what an "independent third party" is. 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 between influencers and followers. There is no mention of how to handle misinformation spread through comment sections, direct messages, or other micro-interactions. Generation Patient’s community of young adults with chronic medical conditions has identified these exchanges as the most impactful and potentially misleading.
Directly address the advertising strategy of following TikTok trends. 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.
Provide greater clarity on what kind of organizations this guidance applies to. The guidance lacks explicit mentions or examples of the kinds of organizations this applies to. Organizations and paid influencers alike should be held to the same accountability standard for sharing false/misleading information.
Provide data on the benefits of the FDA’s actions. While FDA has outlined some of its public actions to combat misinformation, we need data on the benefits of the FDA’s actions, especially for websites like FDA’s Rumor Control which require resources to produce. Could these resources be better spent elsewhere?

As the FDA goes further into its new oversight over this space, it is essential that they engage young adult patients and bring them in to co-create material, assess health information, and inform regulation. No one knows the danger of this content better than us.