FDA Guidance Says Companies Have Broad Leeway to Correct Misinformation | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The US Food and Drug Administration (FDA) has released a new draft guidance document on social media focused on how companies can correct blatant misinformation contained on the Internet and social media channels, long a source of frustration for FDA-regulated companies.

The agency is now out with its third social media draft guidance, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.

As FDA explains in the guidance, the Internet has made is considerably easier for outside third parties—from other companies to consumers—to disseminate information about drugs, including factually incorrect or misleading information.

And that information sometimes finds its way onto websites where the sponsor of a drug product has the opportunity to correct misinformation about the product. The question companies have had until now is, ”How can we do so without falling afoul of FDA regulations on product promotion?”

The fear of some companies was that by responding with anything other than full and complete prescribing information, the companies might be cited for misleading promotion. And in many forums, companies are constrained in the space they have to respond to someone.

The good news for companies: FDA says it "does not intend to object" if a company "voluntarily corrects misinformation [posted by a third party unaffiliated with the company] in a truthful and non-misleading manner"—a manner described in FDA's latest draft guidance.