August 8, 2024 Industry Updates

FDA Updates Guidance to Address Medical Misinformation

This revised guidance issued on July 8, 2024, replaces the 2014 draft guidance and is open for public comment for 60 days. Stay informed and help fight the spread of misinformation.

The FDA is enhancing its efforts to ensure the public has access to accurate, up-to-date science-based information about FDA-regulated medical products. The updated recommendations aim to empower companies to address misinformation related to their products. 

 

Why Is This Important?
While many health care providers and consumers turn to the internet for health and medical information, not all information found online is reliable. The popularity and ubiquity of social media platforms has allowed false, inaccurate, or misleading information about medical products to spread rapidly to a wide audience. Medical decisions based on inaccurate information can have detrimental effects and lead health care providers and patients to choose treatments that are unsafe or ineffective, or to forgo treatments that might be helpful and effective.  

FDA Commissioner Robert M. Califf, M.D., has emphasized that the “spread of rumors about science and medicine continues to put patients and consumers at risk.” In response to the current digital environment, the FDA believes it is crucial to address misinformation about medical products, and to support the efforts of companies that provide factual, accurate, and scientifically sound information. 

 

What Are the Key Updates?
The revised draft guidance supports companies whose online communications address online misinformation spread by a third party (e.g., responding to a celebrity, influencer, or health-care provider who posts false or misleading information about the company’s medical product). The guidance also provides examples of the types of misinformation found online, encourages companies to issue “tailored responsive communications” when applicable, and highlights considerations and available channels for addressing misinformation.  

The FDA remains committed to providing factual information through various channels and supports companies’ ongoing efforts to tackle misinformation.  

 

This revised guidance issued on July 8, 2024, replaces the 2014 draft guidance and is open for public comment for 60 days. Stay informed and help fight the spread of misinformation.