Thanks to my friend Mark Senak (of Eye On FDA blog) for breaking the news/story late last night (DEC 20th) that the FDA has announced a delay on the issuance of Internet and Social Media Guidance, that was originally planned for release by the end of 2010 (or at least part of it).
According to Mark, an email was sent by the Center for Drug Evaluation and Research (CDER) announcing the following:
The Division of Drug Marketing, Advertising, and Communications (DDMAC) has been researching draft guidance topics on the following issues related to Internet/social media promotion of FDA-regulated medical products:
- Responding to unsolicited requests
- Fulfilling regulatory requirements when using tools associated with space limitations
- Fulfilling post-marketing submission requirements
- On-line communications for which manufacturers, packers, or distributors are accountable
- Use of links on the Internet
- Correcting misinformation
Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed. The public will be notified officially when any guidance is issued via Federal Register announcements.
You may recall that this all started with the FDA Open Forum to address Internet and Social Media guidance in NOV 2009. Over the course of the year since then, general chatter and bits of information that were revealed at various conferences where the FDA presented, etc. (e.g. see Pharma Marketing Blog, NOV 1st, 2011) suggested that the FDA was planning to release guidelines: (1) by the end of 2010, (2) in a modular format, and (3) that would not address Adverse Event issues initially.
While many have been skeptical about the timing and some even had countdown clock widgets installed on their blogs , I believe many were holding on to a glimmer of hope that something would at least give us an indication for what to expect. In fact, I was at a recent conference in NYC, where an attendee asked a speaker from CDER if they could even just confirm a general date/timeline for when to expect the guidelines. So…I guess that’s what we have for now–a vague sense of what to expect. I guess we’ll just have to wait and see what happens in Q1, 2011.
Also see other commentary on this issue:
World diabetes day is NOV 14th. In preparation for that, please watch the Big Blue Test video below (a Diabetes Hands Foundation initiative) — every time the video is watched, a donation will be made. As a result, a child with diabetes in need will get a week’s worth of insulin, which they need to live. The more views the video gets, the bigger the impact!
“For 2010, the Big Blue Test is even bigger! Together with Roche Diabetes Care, makers of ACCU-CHEK® diabetes products and services, DHF is aiming for a minimum of 100,000 views of its Big Blue Test promotional video. To help the foundation reach this goal, Roche has underwritten the production of the video and will make a donation for every view the video receives up to $75,000. DHF will use the donation to help Insulin For Life and the Life for a Child program, run by the International Diabetes Federation. These two global, humanitarian organizations provide diabetes medication and supplies to children in the world’s poorest countries.“
If you are someone with diabetes, you can also JOIN the Big Blue Test in solidarity with other people with diabetes — all it takes is 14 mins on NOV 14th at 1400hrs . Details are at BigBlueTest.org, but here are the basic steps:
- On November 14 at 2 pm, test your blood sugar.
- Get active for 14 minutes.
- Test again.
- Enter your results at BigBlueTest.org
The last few weeks have really been heating up for me… I mean, I’ve been really busy this year in general, but over the last few weeks, things have really turned up a notch at work (and at home, for that matter). In fact, in the past 3+ weeks alone, I’ve traveled to Philly (x2), New York City, and Chicago, which includes my attendance at two major conferences (e-Patient Connections and Digital Pharma East) and Google ThinkHealth’10. As a result of all this, I realize that my blogging on Med 2.0 has been suffering of late; even with my feeble attempt to revive it earlier this year.
Now, remember back at the end of 2008, when I introduced Erik van der Zijden (from Digiredo in the Netherlands) as a co-blogger on Med 2.0? Well, in order to continue growing this blog and providing regular updates, I’ve decided to invite another good friend to join me in co-authoring this blog. So, it is with great pleasure and privilege that I have the distinct honor of introducing my new co-blogger on Med 2.0: Marc Monseau from Johnson and Johnosn.
[pro-player width='400' height='275' type='video']http://vimeo.com/11150719[/pro-player]
If the video does not work, you can watch it here: http://vimeo.com/11150719
Like many of you, I have deep respect for Marc and have looked up to him since the “early days” (like 4-5 years ago) as a real leader and innovator in the field. Over the last few years, I have gotten to know Marc quite well — especially since we seem to be on a similar conference circuit — and have come to realize that we share many similar values and ideals for the Social Pharma/Health space overall. So, for me, it is a true honor to share my blogging space with my friend and mentor in this space, Marc Monseau… Please help me give him a warm welcome to Med 2.0 and be on the look out for his upcoming posts .
In case you don’t know, October happens to be health literacy month. What’s “health literacy” you ask? It’s basically “…the importance of understandable health information”. Think about medical materials that contain clinical jargon/words to describe complex medical issues. Think about a medical visit where you walked out more confused because you didn’t really understand what the doctor was saying (but were afraid to ask)… and even more so, if it’s right after you’ve received some news that you weren’t expecting. Health literacy is important — to learn more, visit the HHS “Guide to Writing and Designing Easy-to-Use Health Web Sites” and watch this Institute of Medicine (IOM) video for a broad perspective.
Anyway, today (October 7th), Healthfinder.gov will be having a live tweetchat with CDC’s Health Literacy Advisor, Cynthia Baur, from 2-3pm ET. To make it easy to follow along, I’ve created a “live feed” to capture the tweetchat using the hashtag #HealthLit (note: the feed will capture any conversation using the hashtag): Click here for the live feed via CoverItLive.
If you enjoyed reading the quintessential social media “bible” Groundswell (by Charlene Li and Josh Bernoff) as much as I did, then you’ll be pleased to know that Josh (together with co-author Ted Schadler) has recently released a new book entitled “Empowered: Unleash your employees, Energize your customers, and Transform your business“.
You’ll be even happier to know that till the end of this first week of the book’s release (ending Friday, SEP 10th), you’ll be able to download your own copy for your kindle ABSOLUTELY FREE (don’t forget, you can also read kindle books on your iPhone/iPad using the kindle app). NOTE: The free kindle book offer is only valid for US based Amazon accounts.
You can read more about Empowered on Josh’s blog post “Strategic generosity: Who, how, and why to give out free stuff” and both Josh Bernoff and Ted Schadler will be hosting a webinar on Friday, SEP 10th, from 12-1pm. Here’s a brief description of the webinar and the book:
Thanks to the groundswell, your customers now wield unprecedented power through social, mobile, and other technologies. Your employees are already using these technologies to transform the way you do business. You can lead them or block them. It’s your choice.
Empowered provides real-world examples of how innovative leaders and their teams use technology to solve customer problems. We call them HEROes highly empowered and resourceful operatives. They’re people like John Bernier and Ben Hedrington at Best Buy, who built an army of 2,500 tweeting employees to reach out to customers online.
Please join us for this upcoming Webinar, where Empowered co-authors Josh Bernoff and Ted Schadler will review the ideas behind the book and explain what it means to be empowered.
As you would have seen from my recent blog post, I am ecstatic about the fact that the 2011 South by Southwest (SXSW) interactive festival will have a “Health Track” as part of it’s mainstream sessions and, what’s even more exciting, is that a big part of this was due to the success of the Social Health 2010 unconference (read: “New for SXSW 2011: One-Day Health Track“). And to top that off, I have also been invited to be a member of the 2011 SXSW Advisory Board for “Health” — you can see how sessions are scored on the Panel Picker here.
While I am extremely honored to be on the “Health Track” ad board, one disappointing “side effect” is that I am not able to submit a proposal for a session within the “Health Track” (it would be silly to judge your own submission )
If you work in a regulated industry (e.g. pharma/biotech, healthcare, financial services, alcohol, automotive, etc.) or simply in a conservative corporate culture and want to learn from the experience of some well respected pioneers in the field, then please consider voting for our panel. The session details are stated below… THANK YOU in advance for your consideration and votes (if you like it).
While many businesses and corporations have started to adopt social media as part of their marketing, communications, and other business practices, regulated industries – such as pharmaceuticals, financial services, and the automotive industry – often face challenges and restrictions that other industries do not need to consider, such as federal regulations and industry guidelines.
This panel brings together an esteemed group of social media pioneers within regulated industries, who have not only transformed their organization’s approach to social media, but also successfully planned and executed numerous social media programs, while adhering to their respective industry regulations and limitations. The session will cover:
- A general overview of some regulated industry regulations/ limitations
- Championing organizational change, with respect to digital communication
- Developing internal policies/guidelines for social media
- Working with internal legal/regulatory departments for reviews and/or approvals
- Developing social media strategies within highly conservative corporate culture
- What are some of the federal/industry limitations that challenge regulated industries?
- How do you get around existing internal policies and guidelines that prohibit social media activities?
- What needs to be established before implementing social media within conservative corporate cultures?
- How do you develop an ongoing process that meets the expectations of the social media culture, yet adheres to the limitations of being regulated?
- How do you develop and implement strategies that will work within the conservative limitations of a regulated industry?