10/10/2024

Photo by Hartono Creative Studio on Unsplash

The internet is the leading source of health information for most consumers, patients, and healthcare providers, which has led to growing concerns that the spread of misinformation on the internet will put the public at risk of using unsafe or ineffective treatments or therapies. To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform the firms (entities legally responsible for the labeling of approved/cleared medical products) about how to voluntarily address misinformation about their medical products. The guidance defines misinformation as “implicit or explicit false, inaccurate, or misleading representations of fact about or related to the firm’s approved/cleared medical product”. The guidance proposes two options for firms to address misinformation about their medical products:

1. Tailored Responsive Communications (TRC)

This option is recommended for addressing internet-based misinformation about a firm’s approved/cleared medical product created or disseminated by an independent third party that suggests the product be used for unapproved uses or references a basis that falls within the definition of misinformation. The guidance lists several hypothetical scenarios that outline when it would and would not be appropriate for firms to use a TRC.

A TRC would not be appropriate when the communication describe an individual’s experience, opinion, or value judgement, for example:
- An influencer claims Drug X did not work for him and recommends his followers do not use Drug X. This is an example of their own personal opinion.
- A celebrity states that Drug Y works better for them than Drug Z. Again, as they are talking about their own experience with the drugs it is not appropriate to respond with a TRC.
A TRC would be appropriate if the communication suggests a product be used for unapproved purposes or fits the definition of misinformation, for example;
- An independent healthcare provider posts on their social media stating that Drug A causes Alzheimer’s disease despite their being no evidence of the sort. This statement falls under misinformation because it is false, inaccurate, or misleading.
- A popular blogger claims that using Drug B is great for preventing pregnancy, and also says that it can be taken after intercourse to prevent pregnancy. The first half of this post would be considered an opinion, saying that a drug works great. It is the ladder half that is considered misinformation since the drug is supposed to be taken before intercourse to prevent pregnancy and they are claiming it works even after for which there is no evidence and could influence member of the public to improperly use the drug.

The guidance then goes on to explain what should be included in a TRC including what to specifically identify about the misinformation, what relevant information to include, where to send the TRC, and any additional disclosures a firm should use.

2. General Medical Product Communications

The second option consists of all the already existing pathways that firms may take to communicate information about their approved/cleared medical products that, unlike TRCs, does not need to be internet-based or address a specific piece of identified misinformation. Examples of general medical product communications include:

Sales ads
TV commercials
Radio advertisements
Enlisting influencers to convey the firm’s message

So long as the firm complies with FDA Authorities on this matter (for more information on the regulations please see the guidance for industry “Medical Product Communications That Are 721 Consistent With the FDA-Required Labeling: Questions and Answers”) they can choose to either directly address misinformation or implicitly to keep attention away from the source of the misinformation.

The entire guidance document can be found on the FDA website here, the draft is not longer open for comment however there is additional and supplementary information on the FDA website here. In addition to the updated guidance, to mitigate the spread of misinformation the FDA is continuing to add resources and up to date science-based information to their own website and social media platforms. They have also been and will continue to engage with the public by participating in public speaking events, providing toolkits for preventing and addressing misinformation to interested parties, and posting memos and regulatory documents to keep the public informed on their decision-making surrounding the matter.

-The Clinical Pathways Team

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