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FDA updates guidelines to address misinformation about medical devices

The US Food and Drug Administration (FDA) has updated official guidelines in a bid to address misinformation about medical devices and drugs disseminated by celebrities or online influencers, setting out guidelines for how healthcare companies should challenge online falsehoods.

The new draft guidance, entitled: “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers”, outlines how healthcare firms should respond when a third party shares false or misleading information about an FDA-cleared product, illustrating the types of misinformation found online that a company might choose to address with what the guidance calls “tailored communication”.

The revised guidance comes with examples of previous medical information such as the direct impact on AIDS patients throughout the 1980s and 1990s as a result of misinformation spread through traditional media channels regarding the nature of how the condition is spread. The FDA cites the imperative to prevent the same levels of damage now that medical misinformation has become more accessible and tailored through apps such as TikTok or Twitter.

FDA Commissioner Robert Califf said: “Regulated industry plays a critical role in ensuring consumers have accurate information about medical products. We’ve updated our draft guidance to help further ensure the industry has clarity and additional flexibility to promptly and proactively issue responsive communications to address misinformation they are seeing.

“The growing spread of rumours about science and medicine continues to put patients and consumers at risk. 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 announcement follows after research carried out by UK-based medical journal The Lancet discovered that on the popular social media app TikTok, posts tagged with #ozempic had been viewed almost 250 million times. These posts typically feature younger women advocating the use of drugs such as Novo Nordisk’s Ozempic. Conversely, research by GlobalData found that the drug is rapidly becoming one of the most discussed drugs on social media.

It also follows after the FDA was forced to combat dangerous product misinformation throughout the Covid-19 pandemic, most notably a surge in people purchasing the anti-parasitic drug Ivermectin.

The draft guidance outlines how companies may want to go around the influencer or source of misinformation and reach out to social media networks directly to seek clarification or have the offending post removed altogether. The draft guidance remains open for comment from the public for 30 days. Medical Device Network

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