Want to challenge online misinformation about your products? The FDA has set out pointers about how to proceed—and how it will regulate companies’ responses—in draft guidance that is open for comment for 90 days.
Misinformation is an old problem. The FDA and other bodies contended with the issue in the early years of the AIDS crisis in the 1980s. But, as the agency says in the draft, the popularity of social media means that today “false, inaccurate and misleading information about medical products can spread rapidly to a broad audience.”
The FDA moved to address that threat by publishing draft guidance on correcting misinformation online 10 years ago. BIO and PhRMA shared feedback on the draft, but the FDA never finalized the text. Now, the agency has rewritten the draft guidance to reflect feedback including comments on the 2014 text.
“Regulated industry plays a critical role in ensuring consumers have accurate information about medical products,” FDA Commissioner Robert Califf, M.D., said in a statement. “We've updated our draft guidance to help further ensure industry has clarity and additional flexibility to promptly and proactively issue responsive communications to address misinformation they are seeing.”
In the latest draft guidance, the FDA outlines two types of responses to misinformation. The first type, tailored responsive communications, are voluntary, internet-based messages that identify and address internet-based misinformation about a company’s authorized product. The second type, general medical product communications, can implicitly or explicitly address misinformation using channels including TV.
Tailored responsive communications have certain privileges under the draft guidance. The FDA plans to exempt the communications from requirements related to promotional communications. In contrast, general medical product communications are expected to comply with all applicable requirements.
The FDA draft gives examples of the social media posts companies can and cannot correct using tailored responsive communications. A person can post their individual experience, opinion and value judgments about a product online. Companies are free to use general medical product communications to address the posts, but tailored responsive communications don’t apply in those circumstances.
Tailored responsive communications, and the exemptions they enjoy, come into play when someone makes a statement online that is false, inaccurate or misleading. Companies can send tailored messages if, for example, a person says a cholesterol drug causes Alzheimer’s disease but not if they don’t like a product because it failed to address their symptoms.
The FDA wants companies to clearly identify the misinformation they are addressing and where it was published in their tailored communications. The draft outlines the ways companies could identify the source of the misinformation as well as factors to consider when drafting communications.
Most of the draft text deals with tailored communications, but the FDA also answers one question about general messages. General medical product communications enable companies to tackle misinformation via channels other than the internet, for example by reaching the general public through a TV campaign.