On July 8, 2024, the Food and Drug Administration (FDA) issued draft guidance entitled “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers.” This draft guidance clarifies when and how drug and device manufacturers may respond to internet-based “misinformation,” defined as “false, inaccurate, or misleading representations of fact” about an approved product. This includes information related to (1) unapproved uses of products, (2) FDA required labeling and instructions, (3) attributes of the product unrelated to any particular use (eg, representations about where a product is made or about its components), (4) incorrect scientific information, and (5) other representations that omit material facts related to the product. See draft guidance at pp. 4-5.

Recognizing the harm that misinformation may cause to “both individuals and the public health in general,” the draft guidance provides specific advice for addressing independent third-party misinformation disseminated “via social media, podcasts, email (eg, listserv), group messaging, and discussion forums.” The draft guidance revises and replaces the Agency’s 2014 guidance (“Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” available here).

The draft guidance differs from prior versions in that it:

• Expands the types of misinformation that can be addressed – eg, it permits responses to misinformation concerning entire classes of drugs/categories of products, whereas the prior version required a product be specifically named
• Offers more flexible forms of responding – eg, prior versions allowed manufacturers to correct misinformation only in the location/medium of original misinformation – now, manufacturers may share their response and link/embed an example of the internet communication being corrected to extend the reach of the correction
• Emphasizes voluntary responses to misinformation most likely to spread quickly – eg, encourages manufacturers to prioritize misinformation that is “trending,” or provided by individuals with large follower bases, and
• Encourages manufacturers to include FDA-approved documents for additional context – eg, through linking/referencing FDA required labeling and patient information.

The draft guidance sets out specifications for “Tailored Responsive Communications” that manufacturers may use to disseminate accurate information (without the usual FDA promotional labeling, advertising requirements, and post-marketing submission of promotional communications.

Key takeaways include that the Tailored Responsive Communications must be:

• Truthful and accurate
• Scientifically sound (study or analysis must meet generally accepted design/methodological standards)
• Directly relevant and responsive to the identified misinformation, and
• Limited to the information necessary to address the misinformation. See p. 15.

A few examples provided by the draft guidance include:

A nurse, who is an independent third party, posts on his online blog that a new prescription drug, Drug X, has been approved to treat non-small cell lung cancer.

• Response: According to the Prescribing Information for Drug X, it is a second-line treatment approved for certain patients with non-small cell lung cancer who have tried a chemotherapy regimen containing platinum, but that chemotherapy regimen did not work or is no longer working. The nurse’s post is false, inaccurate, and/or misleading because the nurse omits material facts regarding the full indication for Drug X.

• A content creator on a social media platform, who is an independent third party, posts a video on the social media platform where they make claims that a study has just been found that shows that a prescription drug manufacturer has known for years that its medical product, Drug X, is lethal to humans.
  • Response: The content creator includes a link in their video to a published study that was conducted prior to the drug’s approval. The study described in the publication that is the basis for the content creator’s claims was a safety pharmacology study designed specifically to assess the effects of Drug X on the central nervous system in rats at a range of doses, some that were 40 to 50 times the maximum recommended dose for humans. Central nervous system toxicity leading to mortality was only seen in rats given greater than 40 times the maximum dose recommended for humans in the Prescribing Information for Drug X. The study and the findings do not support the content creator’s statement that the drug is lethal to humans. The content creator’s statements are false, inaccurate, and/or misleading.

Notably, the FDA points out that Tailored Response Communications cannot be used to address opinions, value statements, or representations about a patient’s personal experience with the product. See p. 9. It is therefore important that any responses to statements that include opinions, value statements, or representations are explicitly focused on (1) the actual facts that the manufacturer deems false, and (2) why they are incorrect or misleading.

The comment period for the draft guidance ends on September 9, 2024, in which it will likely become finalized.

For questions or more information, please contact the authors or your usual DLA Piper contact.