John Driscoll, whose book should be on the shelf of every ad/promo professional, has a great tip on his website for searching OPDP's database of enforcement letters.
Instead of entering a phrase such as "FDA Warning Letters" + company name or brand name + issue you want to research, use this link , which is also on John's website.
Then just replace the word "misleading" in the first part of the search for whatever issue you want to research (e.g., "patient testimonials" or "comparative claim" or "peanut butter").
That will search most OPDP/DDMAC letters since 1997. There's some finickiness because the OCR isn't always flawless, but it's a much better search technique that starting from scratch.
Facebook at it again--updates layout
That sound you just heard was the collective sigh of the 25 or so marketers who convinced their companies that Facebook is the appropriate venue for their prescription drugs to have a branded presence. They then spent weeks or months in MLR reviews explaining how everything works and discussing the relative merits of different approaches to presenting risk information in this context.
They're sighing because Facebook just announced another update to its page layout. My colleague Samantha Arabolu has the full rundown here: http://ow.ly/uIh6l
The changes themselves are not earth shattering, and in reviewing them with Sam, I didn't see anything that would cause me to think an initiative that was perfectly fine before would suddenly become non-compliant in after the change.
[BTW, if you disagree and think some of these changes seriously jeopardize things, please say so in the comments on this post.]
Nonetheless, the sigh was heard because all of those materials will have to be updated in light of the new layout, and as FDA made clear at the DIA Marketing Pharmaceuticals conference last month, when the third-party platform you're engaging in updates, then you have to re-submit your materials under Form 2253.
And here's the one and only thing I can guarantee you about Facebook: this is going to happen again. The only guarantee in such arenas is change. And most of those changes will probably be similar to this one. They'll require you to adjust materials, re-review them with MLR, and resubmit to FDA under Form 2253; but they're not likely to revolutionize the platform in a way that significantly alters the core functionality.
So, when you decide to engage in third-party platforms, you simply have to factor in the cost associated with these types of updates because they will happen, and when they do, there will be a cost to update your promotional materials.
They're sighing because Facebook just announced another update to its page layout. My colleague Samantha Arabolu has the full rundown here: http://ow.ly/uIh6l
The changes themselves are not earth shattering, and in reviewing them with Sam, I didn't see anything that would cause me to think an initiative that was perfectly fine before would suddenly become non-compliant in after the change.
[BTW, if you disagree and think some of these changes seriously jeopardize things, please say so in the comments on this post.]
Nonetheless, the sigh was heard because all of those materials will have to be updated in light of the new layout, and as FDA made clear at the DIA Marketing Pharmaceuticals conference last month, when the third-party platform you're engaging in updates, then you have to re-submit your materials under Form 2253.
Q: #socmed changes platform on you. Must you resubmit the initial piece? #diamktg
— Dale Cooke (@PhillyCooke) February 27, 2014A: (Abrams) Yes, you do. Could completely change presentation of the piece #diamktg
— Dale Cooke (@PhillyCooke) February 27, 2014And here's the one and only thing I can guarantee you about Facebook: this is going to happen again. The only guarantee in such arenas is change. And most of those changes will probably be similar to this one. They'll require you to adjust materials, re-review them with MLR, and resubmit to FDA under Form 2253; but they're not likely to revolutionize the platform in a way that significantly alters the core functionality.
So, when you decide to engage in third-party platforms, you simply have to factor in the cost associated with these types of updates because they will happen, and when they do, there will be a cost to update your promotional materials.
New Reprint Guidance
I have been reading the new guidance from the FDA on distributing reprints while preparing a Regulatory Alert, which should be released on Monday or Tuesday. One thing that really stood out to me is the change in the background section.
The background section from the 2009 final guidance had a three-paragraph section lasting less than one page. By contrast the new guidance has a background section that spans five pages and 15 paragraphs, with almost as much contained in footnotes detailing the legislative history as in the guidance itself.
This document definitely reads to my eyes far more as if it were written with the intention of being defended in a court of law than the 2009 version.
I'd love to hear from anyone who had a similar impression.
The background section from the 2009 final guidance had a three-paragraph section lasting less than one page. By contrast the new guidance has a background section that spans five pages and 15 paragraphs, with almost as much contained in footnotes detailing the legislative history as in the guidance itself.
This document definitely reads to my eyes far more as if it were written with the intention of being defended in a court of law than the 2009 version.
I'd love to hear from anyone who had a similar impression.
RAPS Philadelphia Chapter Presentation
I'll be speaking at the Philadelphia chapter of the Regulatory Affairs Professionals Society on April 1 at the Homewood Suites Hotel in Malvern.
I'll be covering the first FDA social media guidance, which you can read here.
The presentation will cover my view that is also presented here. In addition, there are updates from the Drug Information Association's Marketing Pharmaceuticals conference last month. BTW, here's one of my presentations from that event.
Here's the registration page on RAPS website for the April 1 event. I hope you'll join me!
I'll be covering the first FDA social media guidance, which you can read here.
The presentation will cover my view that is also presented here. In addition, there are updates from the Drug Information Association's Marketing Pharmaceuticals conference last month. BTW, here's one of my presentations from that event.
Here's the registration page on RAPS website for the April 1 event. I hope you'll join me!
OPDP Facebook Regulatory Alert
The Food and Drug Administration's Office of Prescription Drug Promotion released an untitled letter for inappropriate use of Facebook to promote a prescription drug. Digitas Health just released a Regulatory Alert to help other companies marketing prescription products learn from this action and ensure they don't face the same consequences. Here's the alert: http://www.scribd.com/doc/212262834/DH-Regulatory-Alert-OPDP-Issues-First-Letter-for-Facebook-Page-Activity
About the Regulatory Rx
This blog will provide a central hub to information that I'm currently making available via Scribd.com and Slideshare.net. This also will provide a venue for some shorter observations and commentary on news and events that I don't believe warrant a full-fledged Regulatory Alert. I welcome your input and hope this venue becomes a place for discussion. Please share your insights.
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