FDA Updates Guidance to Combat Online Misinformation About Medical Products

Updated Guidance: The FDA has issued a revised draft guidance titled “Addressing Misinformation About Medical Devices and Prescription Drugs:
Questions and Answers” to help companies address misinformation about their approved/cleared medical products online.

Regulatory Clarity:
The guidance aims to provide clarity and flexibility for companies to issue responsive communications to address misinformation created or disseminated by independent third parties, such as influencers or healthcare providers not acting on behalf of the company.

Industry Concerns:
Industry stakeholders, including PhRMA, have expressed concerns about the FDA’s approach, seeking more clarity on the applicability of regulations, the scope of authority, and the responsibility of companies in addressing misinformation.

Public Health Priority:
FDA Commissioner Robert M. Califf has emphasized that combating misinformation is a top priority, citing it as a leading cause of preventable death in the U.S..

Examples of Misinformation:
The guidance includes examples of misinformation that companies can address, such as false claims about side effects or unapproved uses of medical products posted on social media or online blogs.

Submission of Comments:
The revised draft guidance is open for public comment for 60 days, allowing stakeholders to provide feedback on the proposed recommendations.

Previous Efforts:
The FDA had previously issued a draft guidance in 2014, which was not finalized. The new guidance revises and replaces the earlier version, reflecting the agency’s ongoing efforts to combat misinformation.