FDA guidance helps companies address 'misinformation'

The US FDA has published updated guidance that aims to help the pharma industry handle misinformation about or related to their approved/cleared medical devices and prescription drugs.

The draft guidance aims to counter a rising tide of rumours and inaccurate information – often found on social media and other online sources – that can put patients and consumers at risk, according to the regulator. It replaces an earlier document that was published around a decade ago.

FDA Commissioner Robert Califf said the new draft will "ensure industry has clarity and additional flexibility to promptly and proactively issue responsive communications to address misinformation they are seeing."

Just one example of the problem is the now-widespread prevalence of vaccine misinformation, which first gathered momentum in the 1990s with scaremongering about the safety of paediatric vaccines and spiralled during the COVID-19 pandemic.

The FDA also cites widespread misinformation in the 1980s and 1990s – through traditional media channels – about the way HIV is spread, likely causing harm to patients.

All too often, celebrities and online influencers use their platforms platforms to peddle conspiracy theories that can drive post views and earn them a financial reward.

The guidance sets out the measures that a company may take if a "celebrity, healthcare provider or influencer" posts false, inaccurate and/or misleading representations of fact on social media, for example suggesting they may want to bypass the individual themselves and reach out to the platform hosting the content.

It covers two approaches, namely tailored responsive communications for Internet-based misinformation and general medical product information communication through channels like sales aids, TV and radio advertisements and institutional communications. Included are examples of communications which may be negative about a product but not fall under the misinformation category.

The draft guidance is open for public comment for 30 days.