The FDA and FTC need to crack down on TikTok and Instagram influencers pitching prescription drugs

In June, the Food and Drug Administration issued a warning letter about advertisements for the drug Recorlev for Cushing’s syndrome — its first in more than a year about webpages that make “false or misleading claims” about prescription drugs. More recently, in December the agency published guidance about TV and radio advertisements.

But the FDA is behind on something crucial: It needs to develop and clarify regulations to protect patients from potential harm and misleading information on social media platforms, particularly from influencers.

Influencers with no medical or pharmaceutical training regularly use these platforms to promote prescription drugs. Khloe Kardashian, for example, has posted ads on Instagram to promote a prescription migraine medication. So have Lady Gaga and gold-medalist Olympic athlete Aly Raisman, who recently endorsed a competing migraine medicine in an ad that began with her talking about Women’s Mental Health Month.

While these posts were clearly marked as ads in compliance with federal guidelines, simply disclosing that something was sponsored is not enough. In 2021, the FDA and Duke Margolis Center for Health Policy found that adolescents and those with chronic conditions are especially vulnerable to pharmaceutical social media direct-to-consumer advertising. This susceptibility and the lack of oversight for such ads could have adverse health consequences, especially for young adult patients.

Influencers, particularly “micro-influencers” with followers of 1,000 to 100,000, wield more power than one may realize. The smaller scale of their audience enables micro-influencers to foster closer connections with their following, creating a “parasocial relationship,” where followers develop a one-sided connection, perceiving the influencer as a trusted friend.

The trust bestowed upon influencers can be dangerous, particularly in the context of potential health misinformation and disinformation propagated through specific drug advertisements. This is especially alarming when messages overstate benefits or minimize harms. Even celebrities may not have the same power as influencers with similar “personally relevant” factors, which could account for the increasing utilization of micro-influencers by pharmaceutical companies. Examining the impact of influencers on their followers presents a regulatory gray area, diverging from the oversight applied to regulated advertisements.

According to FDA regulations, advertisements naming a drug (and what it is used for) must adhere to the principle of fair balance by providing information about important harms similarly to the presentation of information about benefits. Furthermore, advertisements must not be false or misleading. The FDA has recognized the need for further guidance on applying these rules to video-based social media platforms such as Instagram and TikTok. Clarifying statutory authority is crucial to FDA oversight of third-party advertising of prescription medicines, including intermediary agencies or influencers. It is also needed for comment sections where followers, who may or may not also be sponsored, add responses to a sponsored influencer’s content.

But the FDA has not updated its guidance since 2014 and has not held a public workshop regarding social media since 2009, well before the launch of TikTok in 2016. Beyond ads, there are no clear guidelines for regulating comment sections, direct messages, or intimate ways influencers can communicate with their followers about prescription medicines.

The Federal Trade Commission oversees the advertising of nearly all products except prescription medications. It frequently updates endorsement guidelines and hosts public events addressing concerns like safeguarding children from covert advertising on social media.

Now, the FDA needs to work with the FTC to come up with clear guidelines about what influencers can say (and how they say it) about prescription drugs — and not just in widely disseminated posts and videos.

Following past instances of successful collaboration on matters such as biosimilar misinformation, the FDA and FTC should formalize their partnership and jointly address the escalating impact of social media advertisements and influencer-driven promotions of prescription medications. Regulatory agencies should collaborate with independent patient organizations to provide guidance on appropriate disclosures and ethical practices for influencer-sponsored prescription advertisements. FDA and FTC could do a joint public meeting to debate issues and develop their response.

We need a consensus on appropriate sponsorship disclosures and whether the influencer has actually taken the medicine. Regulations should be established for comment sections where there is potential for micro-interactions that could bypass content warnings and influence young patients. Clarifying their oversight of third-party advertisers of prescription medicines and allocating additional funds to the FDA’s Office of Prescription Drug Promotion could enable a stronger Bad Ad Program (which allows people to register complaints about misleading prescription drug promotion), improving its effectiveness in addressing comments related to TikTok and Instagram or other social media platforms.

Influencers or others might object on First Amendment grounds, but tailored regulations addressing critical public health concerns should be permissible. False and misleading commercial speech can be banned under the First Amendment. Moreover, under the Central Hudson test created by the Supreme Court, the government can regulate commercial speech where necessary to directly advance a substantial government interest like protecting public health.

Some question the relevance of influencer endorsements since health care professionals are responsible for prescribing medications. However, physicians are more likely to prescribe medications that patients inquire about based on traditional direct-to-consumer advertisements. Research indicates that such advertising prompts patients to request a specific branded product rather than a more cost-effective generic alternative or non-drug alternative. This is even more troubling when noting the heightened impact that advertising in social media may possess due to a parasocial relationship, in contrast to traditional pharmaceutical advertisements.

The daunting open question is how regulators might effectively monitor the vast universe of social media posts for misleading drug promotion. A first step might be for content sponsors to list all sponsored influencers in a database maintained by the relevant regulators. Meta and TikTok could link to this database to create an open, comprehensive archive of posts to enable researchers and regulatory authorities to search current and past advertisements of particular therapeutics. They should extend the Meta Ad Library to ensure that the advertisements indexed include sponsored influencer posts and posts directly from the companies. Regulatory agencies could continuously sample random posts from these archives, possibly with AI support to supplement the current regulatory approach, which is complaint-driven. Ultimately, we will also need effective ways to educate influencers’ followers so they are less vulnerable to misleading messaging.

Given the current financial incentives of pharmaceutical companies, it is unlikely that they will willingly embrace stricter ethical standards concerning social media advertising. It is imperative that regulatory bodies, social media companies, and other stakeholders actively engage in meaningful discussions to safeguard the well-being of the present and future generations of patients.

Sneha Dave is the executive director at Generation Patient, a nonprofit representing young adults with chronic and rare conditions. Sydney Reed is the director of operations at Generation Patient, a nonprofit representing young adults with chronic and rare conditions. Steven Woloshin is a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice and director of the Lisa Schwartz Foundation for Truth in Medicine.