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.
7 comments:
Great deck. You will do a superb job. Good luck! Suzanne
Hi Wendy,
The RxRisk (or whatever else it can be called) is the obvious and most simple thing for the FDA to do.
Thus, it is probably the best idea and one that I'm sure many others have considered.
The difficulty will be getting an agency such as Intouch being paid decently / fair remuneration to implement it - the other option of the FDA doing it 'in-house' is liable to fail through time lag and scope creep.
I hope you win the business and we can all move on and start delivering 21st century digital solutions to our customers!
Best,
Dan.
Thanks for your comments!
Dan - thank you for your thoughts and I love the idea of "delivering 21st century digital solutions to our customers."
I do want to make it clear that it's not my intent to win any business for Intouch with the RxRISK approach. It's putting an idea out there that all agencies and co's across the industry could adopt within their current programs (with FDA's blessing, of course).
Any digital/interactive agency, any search agency, any online media agency, any social media agency ... any pharma-friendly agency involved in this space could implement the RxRISK approach on behalf of their current clients. Cheers to progress!
Hi Wendy,
Of course - I wasn't inferring that the hearing was a biz dev exercise for you just that Intouch would be well placed to deliver such a program on behalf of the FDA (should you and they want to). Personally, I think it (RxRisk) would need to be a programme that is implemented by one agency on behalf of the FDA and that there is a commitment to sign every drug, regardless of its place in the lifecycle, up to it. A level playing field on which to move forward.
Wishing you the best of luck with your presentation and hoping that we can raise that glass to progress!
/D
Interesting viewpoint Vertic - I hadn't thought about it as a program that could be implemented by a single entity, but that could definitely make sense in the spirit of keeping things consistent.
There are definitely some details to iron out about who would administer and how it would be administered, how it would be paid for (in terms of educating consumers), etc. Thanks again for your thoughts and for getting the conversation going!
Wendy-- Your suggestion is very much in synch with the way the federal government has approached other health education tasks such as the nutrition labeling on food packages and the "Food Pyramid" of the 1990's.
It wouldn't be hard to implement assuming it was mandated by the FDA and it could simply link to risk information already approved by the Agency. The FDA would want to see "behavioral studies" that verify that consumers would accept this pathway to risk info. These would take time and I am not sure who would pay for them. But it's a worthwhile investment.
Wendy, thanks so much for sharing the slides you will present at the hearings tomorrow—much appreciated! I applaud your effort to put forth a solution to a problem few people have been willing to take head on. Where I struggle with the RxRisk proposal and similar ideas (FDA-approved stamp) is that it seems like an approach best suited for advertising. What I mean by this is for areas where there is some ambiguity such as search advertising I agree that this solution would be useful to distinguish legitimate content. However, I am not sure it is the best fit for social media platforms. The problem in my eyes is that it sends the wrong message to pharma marketers—that social media is about finding a way to push branded content. I know that is certainly not your implication but I’m not sure if that is a universally held truth. I don’t know what the answer is but I hesitate to propose a solution that might tempt some marketers to take the easy route.
Thanks again for posting your content and look forward to hearing your recap of the hearings!
Post a Comment