FDA issues social media guidance

Two new draft federal guidance documents published by the U.S. Food and Drug Administration focus on regulation of medical products and electronic digital platforms and correcting information regarding such devices and prescription drugs via Internet communication platforms.

The first guidance, "Internet/Social Media Platforms with Character Space Limitations--Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices," offers insight on how manufacturers and distributors of media devices should share benefit and risk information on 23 electronic digital platforms, specifically those with character space limitations, such as blogs, Twitter and even online paid search.

The second guidance, "Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices," describes the FDA's view on how drug and medical device makers and distributors should respond to misinformation by third-parties using Internet and social media venues.

"This applies when a firm is not responsible for a product-related communication that appears on the firm's own forum, an independent third-party website, or through social media, and the firm chooses to correct misinformation about its own product contained in that communication," the second guidance states. "In such cases, we recommend that the firm do so as described in this draft guidance."

The guidance documents arrive several months after the FDA announced its intention to track social media talk about product risks. "The objective of this requirement is to provide FDA with the resources needed to use social media to inform and evaluate FDA risk communications," a solicitation notice published to the Federal Business Opportunities website in March said.

Doctors, nurses, pharmacists and healthcare consultants from the U.S. make up most of the healthcare professionals who use Twitter, according to research by Creation Healthcare, a London-based research and training consultancy. U.S. healthcare professionals make up 31 percent of the 75,000 worldwide total of healthcare professionals who turn to the social media site to "tweet" information about healthcare policy, research, individual medicines and treatments for the disease.

For more information:
- read the documents on marketing and data promotion (.pdf) and correcting product information (.pdf)

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