Bring Out the Old ("One-Click Rule") and Ring in the New Ideas
FDA's public notice regarding Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools asked "Are there proposed solutions that may help address regulatory concerns when using social media tools associated with space limitations or tools that allow for real-time communications to present product information?"
FDA's "regulatory concerns" are primarily about how to ensure that consumers have access to a balanced presentation of both risks and benefits of medical products. Given that, the following question asked by the FDA is relevant to the discussion of space limitation solutions: "How should product information be presented using various social media tools to ensure that the user has access to a balanced presentation of both risks and benefits of medical products?"
This article presents a summary of comments from the drug industry regarding this issue.
Topic headings include:
Research Supports Need for More Balance
Pharma Prefers "1-Click Rule"
Yahoo! Says Patients Are Ambivalent About Risk Information
Merck's Data In Support of "One-Click Rule"
BIO Says Consumers "Understand" the One-Click Rule
Who Did NOT Support the "One-Click" Rule?
Google Rescues the Product Claim Ad!
Novartis Proposes FDA-Approved Hashtags
PhRMA Proposes FDA-Approved Universal Safety Symbol