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“Dear FDA, Your Regulation of Pharma's Use of Social Media is In Low Battery Mode,” Says EyeOnFDA

“Dear FDA, Your Regulation of Pharma's Use of Social Media is In Low Battery Mode,” Says EyeOnFDA | Pharma Industry Regulation |

FDA held a public meeting in April 2009 on the regulation of promotional speech on social media by medical product manufacturers and set the framework for the discussion (and the subsequent regulation) by asking five questions. Ostensibly guidance was to follow in short order, but in fact, many years passed before FDA issued guidance documents that only partially addressed the questions raised in that framework. The most comprehensive of these guidance documents were about correcting misinformation by third parties on the Internet and operating in platforms where there is character space limitation. Left unanswered were many questions such as issues related to adverse event reporting, among others.


The sluggishness of the agency is in many ways understandable. Digital media is fast evolving. Platforms develop rapidly and raise many new questions. Platforms also come and go. On the other hand, FDA’s process moves slowly and keeping up is difficult. Many times on this blog have I opined that moving from a system that is reliant on guidance development to something that operated more quickly, such as advisory committee on communications, might help speed things along.


Comparing FDA’s pace in evolving the agency’s regulatory thinking regarding social and digital with the actual developments in these platforms shows a vast gap. Yet the uses and reliance on social media continues to go up. Unfortunately, judging from what is visible with FDA’s plans as made public through future guidance development or research in process indicates that this gap will be narrowing any time soon.


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