Intouch Solutions’ FDA Testimony
I finally got a chance to post my slides for the FDA hearing here.
I’m addressing question #2, which asks how pharma can:
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)
It’s a lot of slides for 10 minutes, I realize. But I have the "luck" of being the next-to-the-last speaker so I figure everyone will have set the stage and done the setup for me already. ("The Internet is important, that’s where patients go to seek health information, there’s lots of misinformation out there, we need guidelines, etc. ...")
I’ll skip over much of the up-front slides. The unique content starts on about slide #14. I was surprised and felt even a bit validated when PhRMA announced a similar recommendation yesterday. Tell me what you think - I’m truly interested in your thoughts.
Thanks to HealthCentral and fdasm.com for their leadership in providing online gathering places for those interested in the hearing. (You can see many of the other presentations that have been posted on the HealthCentral Web site or through the collection of links at fdasm.com .) I look forward to seeing many of you in D.C. Thursday and Friday. And you can bet I’ll be posting some thoughts here following the hearing as well.
If I don’t get a chance to say it during the 10 minutes I speak on Friday, it’s important to note that these slides are not just MY thoughts. They are the collective result of many discussions, brainstorms, debates, knowledge, experience, help, and feedback of many smart people here at Intouch Solutions that are also passionate about digital pharma.
So THANK YOU, Jim, Faruk, Megan O., Craig, Julie, Greg, Chris, Dave, Shea, Angela, Sarah, Marty, June, Paul, and everyone else that helped in ways big and small! I cannot thank you all enough for your insightful, quick-turnaround help and support.