The Food and Drug Administration (FDA) has released drafts of two new guidance documents that are relevant to companies offering prescription drugs or medical devices (collectively, “medical products”) using Internet and social media platforms. Such guidance expresses the agency’s current views on the covered topics, but is not binding on companies or the FDA. Comments on both guidance documents are due by September 16, 2014.
First, the FDA issued Guidance on “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.”3 The draft emphasizes that companies are not required to monitor or respond to misinformation that is created or disseminated by independent third parties, including user-generated content that appears on a company’s own social media forum. However, the guidance notes that companies may voluntarily choose to correct misinformation, and provides standards for doing so in a manner that will not trigger FDA objections. The draft guidance applies only where companies are not responsible for the initial misinformation. Among the principles set forth in the draft guidance, the FDA states that appropriate corrective information is relevant and responsive to the misinformation, limited and tailored to the misinformation, accurate, non-promotional, consistent with product labeling, and supported by sufficient evidence. A company need not respond to all misinformation that is posted, but should define what portion of a forum it is correcting and then address all misinformation within that portion.
The FDA also issued draft guidance on “Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.”4 This draft guidance sets forth principles and hypothetical examples that are intended to help companies make required risk/benefit disclosures effectively using character-space-limited platforms. According to the FDA, where a specific platform does not allow for an accurate and balanced presentation of a product’s risks and benefits, the company should reconsider using the platform for promotional messages.