FDA updates guidance for addressing medical misinformation

On July 8, 2024, the United States FDA updated its draft guidance Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers for Industry. The updated recommendations outline various strategies that companies with FDA-approved or FDA-cleared medical products can use to address misinformation related to their products.

Medical misinformation is a dangerous challenge to the healthcare industry, gathering more attention throughout the COVID-19 pandemic when misinformation regarding the virus, mRNA vaccines, and COVID-19 treatments ran rampant.

On a broad level, medical misinformation can result in patients and providers making incorrect healthcare choices that can result in adverse or potentially fatal outcomes.

However, industry members and leaders can be critical in addressing and correcting misinformation.

“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 We’ve updated our draft guidance to help further ensure industry has clarity and additional flexibility to promptly and proactively issue responsive communications to address misinformation they are seeing,” said FDA Commissioner Robert M. Califf, MD, in the press release. “The growing spread of rumors 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 guidance outlines tools for identifying and addressing medical misinformation related to a firm’s approved or cleared product, provided in internet-based communications or disseminated by a third party.

For example, companies can use the examples listed in this guidance to determine how to handle an influencer or celebrity who is not affiliated with the product and is spreading misinformation in the media.

In general, the guidance offers steps for companies to assist in addressing medical information.

Additionally, the FDA is also taking steps to address misinformation, including offering timely, accurate, and easy-to-understand information to news outlets, creating resources to address common questions, engaging with the public on medical products and public health issues, offering resource toolkits and posting memos or regulatory documents outlining FDA decisions.