‍The FDA's New Guidance on Misinformation and What it Means for Industry‍

The pharmaceutical landscape is no stranger to the challenges of misinformation. In an era where digital communication dominates, the rapid spread of false or misleading information about medical products can have serious implications for public health. To address this growing concern, the U.S. Food and Drug Administration (FDA) has recently released updated draft guidance to help companies tackle misinformation about medical devices and prescription drugs. This new directive offers both a challenge and an opportunity for pharmaceutical manufacturers to take a more proactive stance in ensuring accurate, reliable information reaches patients and healthcare providers.

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The Challenge of Misinformation

The FDA’s new guidance recognizes the unique challenges posed by the digital age, where misinformation can spread quickly and widely. The guidance emphasizes the agency’s desire for pharmaceutical companies to more proactively address false claims, specifically outlining two primary avenues to do so: “Tailored Responsive Communications” and “General Medical Product Communications.”

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The guidance describes Tailored Responsive Communications as highly specific, internet-based communications that a manufacturer may choose to release in response to false or misleading information.  The FDA allows some flexibility in these communications by not requiring them to adhere strictly to the FDA’s usual promotional labeling and advertising regulations, as long as they meet certain criteria. For instance, these communications must be truthful, non-misleading, and directly responsive to the identified misinformation. Additionally, they should be scientifically sound, meaning any claims made must be backed by robust evidence that adheres to accepted scientific standards.

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The second category of outreach, General Medical Product Communications, offers a broader mandate. These communications include traditional forms of outreach, such as advertisements and sales materials, which can also be used to counteract misinformation. Unlike tailored responses, these communications must fully comply with all FDA regulations, including those related to promotional labeling and advertising. The FDA’s guidance emphasizes that while these general communications can be a powerful tool in addressing misinformation, they must do so in a way that is consistent with the approved uses of the product and must not mislead the audience.

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The Importance of Context

An important aspect of the FDA’s guidance is its focus on contextual accuracy. When addressing misinformation, companies are encouraged to provide enough context to ensure that the corrected information is fully understood by the audience. This means that while the communication should be concise and targeted, it should also include all relevant facts necessary to paint a complete picture. For example, if correcting a claim about a drug’s side effects, the communication should not only refute the false claim but also provide accurate information about the drug’s safety profile as outlined in the FDA-approved labeling.

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The FDA’s guidance also highlights the importance of transparency. Companies are advised to disclose that the information is being provided by the firm or on its behalf, ensuring that the audience is aware of the source. This transparency is crucial in maintaining the credibility of the communication and ensuring that the corrected information is received as trustworthy.

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A Broader Trend in Patient Education

Perhaps most notably, the newly-released guidance is yet another step in the FDA’s broader effort to encourage pharmaceutical companies to engage more actively with the public and ensure that accurate, balanced information about medical products is widely disseminated. This effort has only accelerated since the agency’s COVID-era recognition of the critical role that pharmaceutical companies play in public health communication.  For example, the FDA has increasingly focused on how pharmaceutical companies interact with the public through digital and social media platforms, providing recommendations on how to present risk and benefit information in a way that is clear, concise, and accessible to the public. 

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More broadly, the FDA has sought to ensure that companies are contributing positively to public understanding of medical products, either directly or indirectly.  Examples of these efforts include: 

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• The FDA’s “Rumor Control” Initiative: Launched in August 2022, the FDA’s Rumor Control webpage is another example of the agency’s proactive stance on misinformation. This initiative not only addresses rumors directly but also provides tools and resources for the public and companies to help stop the spread of misinformation. 

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• Enhanced Social Media Presence: The FDA has also bolstered its own presence on social media to combat misinformation directly. By setting this example, the FDA implicitly encourages pharmaceutical companies to do the same—engaging with the public where they are most active.

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• Public Health Campaigns: The FDA has been involved in several public health campaigns that aim to disseminate accurate information about drug safety, efficacy, and proper use. For instance, the FDA’s campaigns around opioid misuse and abuse have actively involved pharmaceutical companies in spreading awareness about the risks associated with these drugs and the importance of proper prescribing and use. These campaigns have often included collaborations with companies to ensure that their communications align with FDA messaging and reach the intended audience effectively.

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• Promotion of Biosimilars: The FDA has also been encouraging pharmaceutical companies to educate the public and healthcare providers about biosimilars, which are often subject to misinformation or misunderstanding. In collaboration with industry, the agency has developed educational resources and toolkits to help spread accurate information about the safety, efficacy, and regulatory approval process of biosimilars. By involving pharma companies in these educational efforts, the FDA is signaling a clear expectation that these companies play an active role in promoting objective information to the public.

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• Patient and Provider Engagement: The FDA’s emphasis on engaging with both patients and healthcare providers is evident in its guidelines on Direct-to-Consumer (DTC) advertising and communications with healthcare professionals. These guidelines underscore the importance of providing balanced information that helps the public and healthcare providers make informed decisions. 

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Taken as a whole, the FDA’s efforts over the past several years provide a clear directive: pharmaceutical companies should take an active role in managing the information landscape surrounding their products.  By actively addressing misinformation and meeting patients where they are in their patient journey, pharmaceutical companies not only protect their brand and reputation but also contribute to the broader goal of safeguarding public health.

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What kind of misinformation have you addressed in your role? How are you bridging the information gap? Drop us a note or join the conversation on X (@ostrohealth).

Matt Bedan is Ostro’s compliance director.  He is a former prosecutor, white-collar litigator, and regulatory compliance professional with over 15 years of experience assisting global healthcare and life sciences companies.

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