FDA, Fair Balance and Social Media
Mark Senak, social media advocate and author of the EyeonFDA blog, has been spot on with his commentary on the recent public hearings held by FDA to unravel the social media conundrum facing the life sciences industry. Despite its good intentions, the agency is intent on applying an anachronistic method of developing guidance (designed for processes that undergo incremental changes) for a technology that changes rapidly and is ill-defined. In other words, they are trying to force a square peg into a round hole—it simply won't work!
As duly noted by Mark, FDA seems focused on inconsequential and banal issues like fair balance. The whole concept of fair balance has never been clearly defined and companies continually do everything possible to test the agency's resolve on the issue by finding new ways to push the envelope.Therefore, it makes no sense to me that the agency would choose to focus on the question of fair balance and social media when more pressing issues like adverse event reporting, responsibility for site content(when tools like Google Sidewiki are available to Internet users ) and off-label promotion of approved drugs and devices. As Mark rightly points out, is anybody really going to read the fine print about side effects and adverse events associated with a drug when they click through on an ad that promotes a medicine that might help them? Do people really read the product insert forms that accompany all prescription drugs?
Don't get me wrong. I am not trying to play down the importance of fair balance but DTC advertising is old hat and most experts agree that it really doesn't work well to sell prescription drugs. To that end, I think FDA needs to throw out the old play book and create a new one for social media. Unlike previous regulations, the ones that will guide social media need to be flexible and adaptive enough to accommodate the rapidly changing social media landscape. Nobody said it was going to be easy but that is why FDA employees get paid the big bucks!
Until next time....
Good luck and Happy Thanksgiving!!!!!!!!
