The FDA on Monday laid out its latest expectations for how pharma companies can correct misinformation spreading online about their medical products.
The draft guidance, which comes in the form of a Q&A and reworks a similar version from 2014, is the latest in a series of FDA efforts to combat misinformation more broadly, which FDA Commissioner Robert Califf has made clear is a top priority for him. But so far, it’s unclear what the speeches from Califf, five of which are cited in Monday’s draft, and online materials have done to slow the spread of misinformation.
There’s a focus on social media in the document. For almost every industry that sells products used by consumers, Facebook, Twitter, TikTok and other social platforms have completely reset how information and opinion is shared and spread, helping connect consumers but also creating a freewheeling environment unbound from any carefully controlled — or regulated — messages about medical products.
For instance, the agency explains how companies can rebut healthcare professionals or celebrities that make false statements online, such as wrongly claiming that certain cholesterol drugs may cause Alzheimer’s disease or falsely claiming a drug has no side effects when they’re included in its label.
A company’s response in these cases should “clearly identify both the specific misinformation that the firm is addressing and a specific internet-based, independent third-party communication,” FDA says.
“The growing spread of rumors about science and medicine continues to put patients and consumers at risk,” Califf said in a statement accompanying the guidance. “We remain steadfast in our commitment to address this public health concern and continue to support and encourage all parties in the public health ecosystem to take an active role.”
The draft offers 13 examples of when companies’ tailored responses to those disseminating false or misleading statements online won’t run afoul of FDA’s regulations, and three other examples when the regulations may still come in play.
Those examples of when the draft guidance likely does not apply include cases where, if a celebrity or individual online shared his or her experience or personal opinion on a specific drug, although companies can still make more general statements.