FDA’s New Draft Guidance for Internet Misinformation about Medical Products
You may remember the internet postings during the height of the COVID pandemic touting hydroxychloroquine, a drug approved by the Food and Drug Administration (FDA) for the treatment of malaria and rheumatologic disease, as a prophylactic or even a cure-all for COVID-19. The postings, many initiated by celebrities such as Elon Musk and Dr. Oz and by social media “influencers,” referenced a now discredited, nonrandomized, 36-patient study on YouTube. COVID misinformation campaigns like this, trumpeting off-label use of an approved drug, took a deadly turn, as some infected patients elected to reject physician-recommended treatments or vaccination based upon the belief, encouraged by social media, that hydroxychloroquine and similar unproven treatments such as ingesting borax, were the ultimate answer.
An Epidemic of Misinformation
The FDA has long recognized the dangers of false medical information spread over the internet, leading FDA Commissioner Robert M. Califf, M.D. to characterize health misinformation as the “leading cause of death in the USA.” Yet when manufacturers of drugs or medical devices encounter misinformation splashed over social media about their own approved products, do they have a legal, ethical, or moral obligation to respond? Moreover, if they choose to respond, what does an appropriate response look like?
In a recently published July 2024 FDA draft document entitled “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers” (the “Draft Guidance”), the FDA sought to answer common questions for firms choosing to respond to internet-based misinformation. In this context, the FDA uses the word "firm" to refer to any person or entity legally responsible for the labeling of an approved/cleared medical product, including applicants, sponsors, manufacturers, packers, distributors, and any other persons communicating on behalf of such persons or entities.
Notably, the Draft Guidance signals the FDA's intention to exercise enforcement discretion with respect to existing product labeling and advertising laws, but only in certain circumstances. While the Draft Guidance helpfully provides several concrete examples of misinformation and a roadmap for response to when such enforcement discretion would apply, many questions remain for firms as to what action, if any, they should take in the face of false claims about their products posted on the internet.
The Draft Guidance
Significantly, the Draft Guidance is not a mandate for action. It does not require firms to respond to internet-based misinformation about their approved/cleared medical products where such false claims are disseminated by independent third parties. However, if firms choose to respond, the Draft Guidance presents a partial blueprint for what firms should include in the response and how to do so. The guidance replaces a prior draft guidance issued in June of 2014, which was subject to significant comment and feedback. The 2014 draft guidance was never finalized, and this updated version includes updated terms, definitions, and strategies that attempt to address how the flow of information, and more importantly, misinformation, has changed over the past decade.
Subsection A of the new Draft Guidance sets out the FDA’s position for firms choosing to tailor their responses to specific instances of misinformation (“tailored responsive communications”). The FDA advises that it does not intend to enforce applicable laws related to promotional labeling and advertising with respect to such communications. In addition, if the communications concern the unapproved use of a product, the FDA will not consider such communications by themselves to be evidence of a new intended use. Put simply, if a firm elects to respond to the misinformation, the FDA will relax legal restrictions for product advertising, labeling, and communications about non-approved use.
Subsection B of the Draft Guidance contemplates that firms may wish to respond to misinformation through existing “general medical product communications,” such as sales ads, TV and radio advertisements, or other promotional materials that are not internet-based. In such circumstances, there are no special considerations to follow when addressing the misinformation. Firms are expected to comply with all applicable labeling and advertising requirements.
Notably, in discussing the contents and format of a “tailored responsive communication,” the Draft Guidance clarifies that it is addressing only “misinformation,” not opinions, value statements, or representations about an individual person’s experience. By way of example, if a social media influencer posts a statement discouraging the use of a treatment for a form of acne because it did not work for them personally, such a statement is not misinformation. Instead, it is considered the influencer’s experience, opinion, or value judgment.
Where there is misinformation, the tailored response should specifically reference the item of misinformation it addresses, perhaps even including a screenshot, but at the very least identifying the location and date where the misinformation was posted. The response, however, need not be posted on the same social media platform as the original misinformation. The tailored response should include a mechanism for obtaining the FDA-required labeling for the product. If the misinformation concerns the off-label use of a product, such as the hydroxychloroquine situation referenced above, the response should explain that the off-label use has not been FDA-approved and the safety of the off-label use has not been established. Of course, the firm should ensure that the information in the tailored response is truthful, accurate, and scientifically sound. (See also this article from the Drug & Device Law Blog for a more detailed outline of the response guidelines).
The many examples provided in the Draft Guidance are helpful for firms seeking to craft a response. For instance, in Example 4, the Draft Guidance relates a situation where a health care provider posts on the internet that a drug used for the treatment of cholesterol has been shown to cause Alzheimer’s disease—a false, inaccurate, and/or misleading claim for which a firm may wish to prepare a response. Example 9 contemplates a social media influencer posting that he is supportive of his wife taking a drug approved to treat a form of acne since she is happy with the results and there are no known side effects. While the statement that his wife is happy with the drug is an opinion, the reference to “no known side effects” is false and, therefore, misinformation the firm should address if they were to issue a response.
Unanswered Questions
The Draft Guidance is a step forward by the FDA in recognizing the dangers of medical misinformation on the internet, particularly in social media, and suggesting how firms may wish to counter false claims regarding their products. Yet central to the discussion is the broader question of how drug and device manufacturers and the persons and entities they work with should protect the integrity of their products in response to internet-based misinformation. In our next blog article on this topic, we will address some of the practical considerations firms may confront in answering this question and highlight pitfalls firms may encounter when wading into the murky and fast-moving waters endemic to postings on social media.
Authored by Phillip Skaggs, J.D., Berkley Life Sciences, Vice President & Chief Legal & Regulatory Affairs Officer