FDA Provides Guidance to Pharma Companies for Correcting Social Media Misinformation

The guidance marks the first update from the FDA on social media misinformation since 2014—and there’s still a long way to go to combat bad health advice on the internet.

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Emma Yasinski
Emma Yasinski Senior Reporter

“My cousin in Trinidad won’t get the vaccine,” rapper Nicki Minaj tweeted in 2021, stating incorrectly that the COVID-19 vaccine caused impotency in a family friend, which led to a broken engagement. 

Inflammatory posts like this swarmed social media early in the pandemic, spreading false narratives about the vaccine, the disease, and appropriate treatment. While online misinformation—wrong information that is spread without malicious intent—may have reached a fever pitch around the COVID-19 pandemic, misleading health claims on the internet are nothing new.  

Experts have long known that misinformation—including misinformation about our health—proliferates rapidly on social media with few guardrails. This false information can lead people to make poor decisions about their health. The FDA has been charged with doing something about it, and the agency’s first step was issuing new draft guidance that updates recommendations made in 2014. The new guidance encourages—but does not require—drug companies to police misinformation on their own products.1 

New FDA Draft Guidance for Social Media Misinformation

The draft guidance describes best practices for pharmaceutical and medical device manufacturers to create messages that combat misinformation about their products online.

Who Should Pharma Companies Correct Online?

First, the guidelines describe the types of posts companies should consider addressing. For example, a drug company should not correct an individual who is sharing his or her own personal experience with a medication but should correct broad claims, such as “statins cause earlobe enlargement,” if there is no evidence that statins have such an effect.

In the case of Minaj’s tweet, the companies that make COVID vaccines should not have addressed Minaj’s post about her cousin’s friend’s individual experience, but they should have responded to the broader claims that circulated afterward suggesting clinical trials had proven the side effect was real.2

How Should the Pharma Company Correct Misinformation Online? 

The FDA recommends that the company create its own post on social media in response to the one that contains misinformation. In the new post, the FDA says a pharma company should identify and correct any and all relevant false statements in the original post and include specific descriptions of when and where the post appeared. The new post should include a disclosure stating that the information is being provided on behalf of the manufacturer and include a link to the drug’s label.

Most posts made by pharmaceutical companies are bound by specific advertising requirements. For example, any drug commercial must include a clear statement of the drug’s possible side effects, to help balance the claims of efficacy. These response posts do not need to include this type of information.

“It gives a little bit more freedom to the company to provide more accurate information,” explains Quan Xie, Ph.D., assistant professor of digital advertising at Southern Methodist University.

What the FDA Guidance is Missing

First, Xie points out that there’s no real way to ensure that people who saw the original post containing misinformation will see the new post correcting it. “I think that’s a very big gap in the guidance,” she adds.

Second, the pharma companies aren’t perfect conveyers of the truth: They have been known to spread misinformation themselves. The FDA is tasked with reprimanding companies when their ads don’t represent the truth or accurately balance a medication’s risks with its benefits. In online ads, which were already subject to regulation by the FDA, a Bloomberg Law investigation found that between 2017 and 2023, the FDA sent 40 letters warning companies of ad violations, seven of which were related to ads on Facebook, Instagram and YouTube.3

The investigation found similar problems among posts made by influencers paid by pharmaceutical companies. Journalists reviewed posts by social media influencers and found that many didn’t contain disclosures stating that the influencers were being paid, and that the FDA rarely took any action against the companies.

The absence of labeling may contribute to consumer confusion. More than two-thirds of adults reported that they weren’t able to tell whether health information they saw on social media was true or false, according to a 2023 survey.4  

FDA guidance is neither a rule nor a law. The documents only represent the FDA’s thinking on a certain topic; the agency cannot enforce these recommendations. While the guidance remains a draft, anyone can submit public comments on it. While the FDA does regulate paid advertisements on radio, television, and social media, the agency has emphasized that it does not regulate the free speech of individuals on social media or elsewhere.

FDA Commissioner Robert Califf told the House of Medicine in June 2023, “One thing we are NOT doing is to suppress free speech. The First Amendment is fundamental to the fabric of the U.S. But institutions can respond to misinformation, both to correct the record and to add to the vibrancy of public conversation.”

Instead, he said to the scientists in attendance, “We need to rebuild this trust. Then we can continue our efforts to convey the results of our scientific, public health and regulatory work in words that can be understood and embraced by the public.”