In a move many are calling long-overdue, the FDA’s social media hearing (formally: Public Hearing on Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools) commenced today. The purpose of this two-day session is for interested parties to comment on Internet and social media promotion of prescription drugs and vaccines. Currently, there is little industry guidance around this topic.
As the FDA’s Tom Abrams noted in his opening remarks, “it would be an understatement to say there is much interest in this area.” More than 800 people tried to register for the hearing, with only about 300 granted seats on a first-come, first-serve basis. In all, the hearing will accomodate about 80 testimonies, primarily from marketing and communications agencies, research companies, health and medical Web sites, major search players, pharmaceutical companies, and consumer groups. Prior to the meetings, the FDA posed five areas of discussion that represent existing challenges—manufacturer accountability, real-time information, corrective information, use of links, and adverse event reporting. Today’s testimonies were devoted to the first four topics.
As expected, nearly every presenter noted that the general public indisputably turns to the Internet for health information, and that the Web is a very different landscape than other media. Many quoted recent Pew research stating that 61% of Americans and 83% of Internet users search online for health information. While the significant need for FDA guidance was made clear, fewer speakers offered tangible solutions. In addition, FDA panel members had the opportunity to ask questions, though participation was relatively limited. Following is a top-line overview of common themes from today’s testimony and some of the recommendations put forth.
General Themes and Consensus (See PDF for detailed report, just the topics listed here for brevity)
- Need for Industry Voice
- Support for One-Click Rule
- Importance of Links
- Content Responsibility Debate
- Specific Recommendations to the FDA
- Universal Safety Symbol
- Standardized Formats
- Key Partnerships
- Social Media Committees
Looking Ahead to Day Two
Tomorrow’s hearing, which will begin at 8 a.m., will focus primarily on the challenges of adverse event reporting online under current regulations, as well as additional testimony on the topics discussed today. Notable speakers include Francer, Mack, Health Central’s Christopher Schroeder, Sermo’s Daniel Palestrant, John Bell and Melissa Davies of Word of Mouth Marketing Association, and Pfizer’s Freda Lewis-Hall and Clifford Thumma. We will provide another summary at the end of tomorrow’s hearing, as well as a comprehensive report early next week.
For updates during the second day of the hearing, we encourage you to follow the conversation live on Twitter through Edelman’s Digital Health team (@EmilyDownward, @EngageInHealth, and @RickMurray). You can also visit us online and share your thoughts here on the blog.
Comments (1)
My impressions from a patient perspective at http://bit.ly/1Kl9if
Posted by DCPatient | November 12, 2009 10:11 PM
Posted on November 12, 2009 22:11