The FDA has announced it will hear public comment on the use of social media to advertise prescription drugs and medical devices. There is a hearing scheduled for Nov. 12 and 13 of this year, and the docket is open for public comment through Feb. 2010.
Our curiosity is piqued, especially around these two questions:
-How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, postmarketing submission requirements) in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g., microblogs, mobile technology)?
-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? Are there data to support conclusions about whether different types or formats of presentations have a positive or negative impact on the public health?
In December 2008, Community Catalyst and the Prescription Project filed a series of petitions asking the agency to establish rules and protocol around the dissemination of risk information in online media, and to advise the manufacturers behind some YouTube ads lacking risk information to review their compliance with current rules.
As for reaction? Mark Senak over at Eye on FDA may win for online enthusiasm: “This is historic. Pass the word. This is a game changer.” But all parties – industry, commentators, and watchdogs – seem to be welcoming the conversation and the clarity this hearing offers.