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FDA draft guidances seek to maintain accurate drug information in new media.
Social media has changed the way people and organizations communicate. Platforms like Twitter and Facebook have demonstrated that they can be effective tools for widespread communication of emergency instructions during natural disasters and in organizing political change in countries with censored media. Social media outlets, however, have limitations when asked to deliver complex, technical information. In addition, the open platform nature of the Internet presents challenges for companies trying to maintain correct information about their products online.
FDA in June proposed two draft guidances that share the agency’s current thinking about how drug and medical device manufacturers can accurately communicate about their products online.
Guidance for Industry, Internet/Social Media Platforms with Character Space Limitations--Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (1) provides recommendations for conveying information about a drug on social media platforms such as Twitter or paid search results links. While the 140-character limit of Twitter may be enough for the latest life updates from figures in popular culture, it will be difficult for drug companies to use the platform under FDA’s proposed guidelines.
In the guidance, FDA notes: “… regardless of the platform, truthful, accurate, non-misleading, and balanced product promotion best serves the public health. For some products, particularly those with complex indications or extensive serious risks, character space limitations imposed by platform providers may not enable meaningful presentations of both benefit and risk … If an accurate and balanced presentation of both risks and benefits of a specific product is not possible within the constraints of the platform, then the firm should reconsider using that platform for the intended promotional message.”
In the draft guidance, FDA indicates that a drug’s risk information must be presented with benefit information in the same limited-character message, such as a tweet. The risk information should include the most serious risk associated with the drug. In addition, a mechanism, such as a hyperlink, must direct people to more information about risks. That is a lot of information to get into 140 characters.
In Guidance for Industry, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (2), FDA explains that drug companies generally are not responsible for comments from third parties who are independent of the drug company that are posted on the company’s website forum, an independent website, or in social media. If a firm voluntarily and truthfully undertakes the correction of misinformation that is within the scope of the guidance, “FDA does not intend to object if these voluntary corrections do not satisfy otherwise applicable regulatory requirements, if any,” the draft guidance reads.
FDA cites the growing the role of social media and notes that the guidance was developed with the best interests of the patient in mind. However, the task of maintaining proper information about regulated products in an unregulated environment may be too great a challenge for FDA or drug companies to manage.
1. FDA, Guidance for Industry, Internet/Social Media Platforms with Character Space Limitations--Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices, Draft Guidance (Rockville, MD, June 2014).
2. FDA, Guidance for Industry, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices, Draft Guidance (Rockville, MD, June 2014).
About the Author
Rita Peters is the editorial director of BioPharm International.