FDA Releases Draft Guidance on Responding to Internet Hogwash

Last week, FDA released for comment a draft guidance titled Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers.  FDA guidances are nonbinding recommendations without force of law, and this is only a draft.  Nonetheless, it addresses a frequent and important problem in our industry.

The guidance provides recommendations for how drug and device manufacturers should deal with hogwash on the internet and social media.  Or, in FDA-speak, how persons or entities legally responsible for the labeling of approved/cleared medical products should craft tailored responsive communications to third parties’ internet-based false, inaccurate, or misleading representations of fact about or related to their products.  This guidance replaces FDA’s guidance from a decade ago, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices, which was never made final.

Anyone with an Internet connection knows about the excess of misinformation out there.  That has always been true, but it was placed in stark relief during the Covid-19 pandemic.  FDA has taken steps to combat misinformation, including launching a Rumor Control page and updating this guidance.

The guidance clearly takes aim at misinformation put out by celebrities and social media influencers. It generally divides a manufacturer’s response into two categories:  (1) “tailored responsive communications”, i.e., a manufacturer’s internet-based response to internet-based misinformation, and (2) “general medical product communications,” i.e., communications through existing avenues available to manufacturers such as sales aids, TV and radio advertisements, and other communications.

The guidance proceeds in Q&A format, providing helpful real-world examples. The core principles from the examples can be summarized as follows:

• The guidance gives manufacturers broad discretion to respond to internet-based misinformation of any form.  This includes misinformation about a specific drug or device or a class of drugs/devices.
• The guidance applies only to “misinformation,” not opinions, values statements, or representations about an individual person’s experience. 
• The tailored responsive communication should clearly identify the specific information that it is addressing (for instance, by including a screen-shot and/or by noting the date and location the information was posted).
• The tailored responsive communication itself should, of course, be truthful and accurate; scientifically sound; relevant; responsive; and tailored to the misinformation.
• The tailored responsive communication should include a mechanism for obtaining the FDA-required labeling; the date of the posting; and clearly identify who is sharing the information.
• If addressing an off-label use, the tailored responsive communication should identify the off-label use and note that the off-label use has not been FDA-approved and that the safety and effectiveness for the off-label use has not been established.
• Manufacturers are not required to respond to all misinformation, nor do they have to respond in the same internet-based setting where the original misinformation appeared.
• Manufacturers are encouraged to take into account the platform’s layout and controls (e.g., engagement buttons), to make sure the recommended disclosures will stay with the response if shared.
• Manufacturers are encouraged to prioritize recent misinformation and prioritize responding to influencers who have more influence.

The guidance also makes clear that manufacturers can continue to use promotional communications to address misinformation, so long as the communications are consistent with applicable FDA labeling/advertising requirements.  The fact that promotional materials are being utilized to address misinformation does not alter any of the FDA’s existing requirements regarding labeling/advertising.

Addressing internet misinformation may be a colossal game of Whac-A-Mole, but it’s encouraging to see FDA arming manufacturers with tools to combat it.