Today is the third anniversary of the first day of the 2-day November 2009, FDA public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (see here, here, and here).
Shortly after that hearing, some FDA staffers lead us to believe that FDA would come out with social media regulatory guidance for the pharma industry by the end of 2010 (see here). That never happened.
Instead, FDA kept procrastinating and throwing roadblocks in the way such as proposing further studies (see, for example, "FDA's Proposed Web Study Will Further Delay Social Media Guidelines").
Meanwhile, to add insult to injury, Tom Abrams, head of FDA's DDMAC (now OPDP), keeps showing up at industry meetings where industry leaders were expecting him to announce progress towards issuing draft guidance. At one such meeting in February, 2011, Abrams spent a scant 4 minutes discussing social media guidance (read this). At that meeting, he said FDA would NOT "do guidance on specific technology platforms such as YouTube, Facebook, or Twitter. Those things are really big now, but you know what, two years from now who knows what the next thing [will be]?" Well, guess what? It's almost two years later and YouTube, Facebook, and Twitter are still BIG, if not BIGGER and nothing has come along that's bigger. [BTW, Abrams also pooh-poohed Groupon, which now seems prophetic! And Google eliminated sidewiki, which was a big concern at the 2009 public hearing (read this).]
In recognition of the role Abrams has played in all this procrastination regarding social media guidance from FDA, I hereby present to Abrams the first ever Pharmaguy Social Media Procrastination AwardTM.
This award, as you may notice, is the antithesis to the famous Pharmaguy Social Media Pioneer Award, which was recently given to the sanofi US diabetes team (see here).
The iconic Hawaiian shirt in the "Procrastinator Award" is dark, symbolizing the negative implications of procrastination versus the bright yellow, positive Hawaiian shirt image used in the "Pioneer Award."
Abrams continues to show up at industry meetings promising that social media guidance is a high priority at FDA and it will be coming soon -- perhaps as "soon" as July, 2014 (see here). Yet, we've heard it all before. That's why I think it is fitting that Abrams receive the the "Procrastinator Award."
If Abrams lives up to his latest promise -- which is doubtful, IMHO -- it would have taken the FDA only 4 years and 8 months to issue draft social media guidance. In terms of Internet/social media timeframes -- in which 2 years can bring BIG changes -- this is procrastination on an epic scale. But in terms of FDA guidance timeframes, 4 years and 8 months is par for the course (see, for example, "A Cautionary Tale for Anyone Expecting FDA Social Media Guidelines Any Time Soon").
Showing posts with label Social Media Pioneer Award. Show all posts
Showing posts with label Social Media Pioneer Award. Show all posts
Monday, November 12, 2012
Sunday, December 12, 2010
Pharmaguy a la Milanese: Deal with Regulations and Develop Best Practices
Pharma's interest in social media is a global phenomenon. I've traveled to the UK and Germany in the past year to present at conferences about what's happening on the pharmaceutical social media front here in the U.S. and its impact on pharmaceutical marketing elsewhere in the world.
My next trip to Europe will be to Milan, Italy, where I will speak at the 6th Annual Pharma Marketing & Branding Excellence conference on January 26. I thank the conference producers -- Jacob Fleming Conferences -- for inviting me to speak and paying my travel expenses.
The title of my presentation is "A Social Media Strategy: Deal with Regulations, Develop Best Practices." Here's the synopsis:
Frankly, I'm hoping that the FDA will release some draft guidance before I leave for Italy so that I can really have something new to talk about. But we're now well in to the holiday season and there has been some concern amongst my Twitter pals that the FDA will not release guidelines by the end of 2010 as we all expected and as the FDA "promised."
But one other issue has arisen that I will incorporate into my presentation: New Media Privacy Issues & Online Health Marketing
I'll also check with locals about my Osso Bucco recipe, which at least one commenter on YouTube claimed was not authentic ("please for the sake and the respect for the italian cuisine never say that what you cooked is ossobucco"; see "Osso Whaaaat? Mack's Osso Bucco recipe!").
My next trip to Europe will be to Milan, Italy, where I will speak at the 6th Annual Pharma Marketing & Branding Excellence conference on January 26. I thank the conference producers -- Jacob Fleming Conferences -- for inviting me to speak and paying my travel expenses.
The title of my presentation is "A Social Media Strategy: Deal with Regulations, Develop Best Practices." Here's the synopsis:
While the benefits of using social media tools as part of your marketing strategy may be clear to your team, the risks are unknown. That’s because there is no bright line that defines what is acceptable to regulators, consumers, and healthcare professionals. Add to this the fact that new tools are being developed at a raid rate, which makes it that much harder to find the line. Each company must access its regulatory risks and develop best practices that not only address those risks, but also instill trust in the audience. This presentation will cover the following:
I'm looking forward to meeting new people, especially new Pharma Social Media Pioneers to whom I give a lapel pin!
- An overview of the regulatory issues pharma companies are facing when they engage in social media
- How to overcome the barriers and risks of having insufficient regulatory guidance on Social Media in Pharma
- Regardless of the regulations, what are some social media best practices that companies should consider?
- What internal and external social media policies & procedures should companies adopt before engaging in social media?
Frankly, I'm hoping that the FDA will release some draft guidance before I leave for Italy so that I can really have something new to talk about. But we're now well in to the holiday season and there has been some concern amongst my Twitter pals that the FDA will not release guidelines by the end of 2010 as we all expected and as the FDA "promised."
But one other issue has arisen that I will incorporate into my presentation: New Media Privacy Issues & Online Health Marketing
I'll also check with locals about my Osso Bucco recipe, which at least one commenter on YouTube claimed was not authentic ("please for the sake and the respect for the italian cuisine never say that what you cooked is ossobucco"; see "Osso Whaaaat? Mack's Osso Bucco recipe!").
Friday, July 23, 2010
On Being Voted Off the Social Media Island
Here's a bit of irony. Today, I was virtually "voted off" the social media (Twitter) island of #hcsmeu by @FarmerFunster for being too promotional. The irony is that many of the topics discussed via #hcsmeu concern how the pharmaceutical industry can get more involved in interacting with consumers via social media, as if that interaction is NOT promotional!
BTW, this is not the first time I've been "voted off" a social media site. See "Banned from CafePharma!" In that case, however, it was a badge of honor :-)
The issue prompting @FarmerFunster to vote to kick me off #hcsmeu was a question I submitted for discussion: "Pharmaguy Social Media Pioneer Award. Who should be nominated?" @FarmerFunster said "principle of it is OK but disagree with #hcsmeu being used as a promo channel within the hour tweet-up."
WARNING! PROMO AHEAD: Learn more about Pharmaguy's Social Media Pioneer Award here.
OK, so I wasn't really "voted off" the island. Only one disgruntled participant felt the topic was inappropriate. But one disgruntled social media participant can have a major impact -- go ask Sanofi-Aventis about that (see "Disgruntled Patient Shuts Down sanofi-aventis Facebook Page") or read "Social Media: Ask Permission to Join the Conversation First or You Just Might Get Your Ass Kicked!"
What @FarmerFunster doesn't realize about me is that "I am all promo all the time. That's what a SM Pioneer shld do." My goal is to promote what I consider good pharma marketing practices. To do that, I need to promote myself and also promote colleagues and sometimes paid advertising clients.
I decided to get involved with awarding excellence in pharma social media leadership because I wanted to promote what OTHER people are doing, not me.
DISCLAIMER: I also am not making one red cent from this effort. There are no PAID sponsors. ExL's Digital Pharma East conference is a sponsor and has offered to provide a venue for the award winners ceremony during the conference. While ExL Pharma is an advertising client of mine, this sponsorship is an unpaid cooperative co-promotion.
Meanwhile, I did get some interesting insights and opinions from other #hcsmeu participants in this morning's discussion. I will review these in another post. Right now I have to avoid the sharks as I swim away from the island.
BTW, this is not the first time I've been "voted off" a social media site. See "Banned from CafePharma!" In that case, however, it was a badge of honor :-)
The issue prompting @FarmerFunster to vote to kick me off #hcsmeu was a question I submitted for discussion: "Pharmaguy Social Media Pioneer Award. Who should be nominated?" @FarmerFunster said "principle of it is OK but disagree with #hcsmeu being used as a promo channel within the hour tweet-up."
WARNING! PROMO AHEAD: Learn more about Pharmaguy's Social Media Pioneer Award here.
OK, so I wasn't really "voted off" the island. Only one disgruntled participant felt the topic was inappropriate. But one disgruntled social media participant can have a major impact -- go ask Sanofi-Aventis about that (see "Disgruntled Patient Shuts Down sanofi-aventis Facebook Page") or read "Social Media: Ask Permission to Join the Conversation First or You Just Might Get Your Ass Kicked!"
What @FarmerFunster doesn't realize about me is that "I am all promo all the time. That's what a SM Pioneer shld do." My goal is to promote what I consider good pharma marketing practices. To do that, I need to promote myself and also promote colleagues and sometimes paid advertising clients.
I decided to get involved with awarding excellence in pharma social media leadership because I wanted to promote what OTHER people are doing, not me.
DISCLAIMER: I also am not making one red cent from this effort. There are no PAID sponsors. ExL's Digital Pharma East conference is a sponsor and has offered to provide a venue for the award winners ceremony during the conference. While ExL Pharma is an advertising client of mine, this sponsorship is an unpaid cooperative co-promotion.
Meanwhile, I did get some interesting insights and opinions from other #hcsmeu participants in this morning's discussion. I will review these in another post. Right now I have to avoid the sharks as I swim away from the island.
Thursday, July 22, 2010
Is This the Fate of Pharma Social Media Pioneers?
Recently, I announced the Pharmaguy Social Media Pioneer Award, which recognizes excellence in social media marketing leadership (see announcement here and latest list of nominees here). The Pharmaguy Social Media Pioneer Award is sponsored by ExL Pharma and the 4th Annual Digital Pharma East Conference. Winners will be announced at the conference in October, 2010.
While reading this week's issue of the New Yorker magazine, I came upon a cartoon that got me thinking about the fate of the people who may "win" this prestigious award.
Could it be that a similar fate awaits the ePharma Pioneers on my list?
I certainly hope not! I also hope that my readers will nominate and vote for candidates here and include some great comments about why such innovators should not be lead to slaughter :-)

While reading this week's issue of the New Yorker magazine, I came upon a cartoon that got me thinking about the fate of the people who may "win" this prestigious award.
Could it be that a similar fate awaits the ePharma Pioneers on my list?
I certainly hope not! I also hope that my readers will nominate and vote for candidates here and include some great comments about why such innovators should not be lead to slaughter :-)
Pharmaguy's Social Media Pioneer Award
Awarding Excellence in Social Media Marketing Leadership
Sponsored by ExL Pharma and the 4th Annual Digital Pharma East Conference
If you are a regular reader of Pharma Marketing Blog, you know that I generally do not like awards sponsored by pharma trade publications (see “Awards. What Are They Good For?”). Such awards are somewhat suspect because of the inherent conflicts of interests involved -- the winners tend to be the agencies that advertise the most in the sponsoring publication or that purchase big page ads announcing that they won the award.
Not all awards, of course, are self-aggrandizing “slaps on the back” among a close circle of colleagues. Dose of Digital’s "2010 Dose of Digital Dosie Award" for the best healthcare/pharmaceutical social media sites depended on a more open and transparent process. First, anybody could add sites to the list of contenders via a wiki site. Then Dose of Digital opened up the voting process to anyone who cared to vote. You can find the winners here.
Still, I find some problems with awards like the Dosie.
First of all, many of the contenders for the Dosie Award were not true social media sites in that they do not allow comments or “likes” (Facebook). This is true of the majority of finalists in the Best Brand Sponsored Patient Community (Communities created by a pharma or healthcare company for a brand or corporate effort). The finalists in this category were:
- Accu-Check Diabetes Link (Roche)
- Children with Diabetes (J&J Lifescan)
- Crohn's and Me (UCB)
- Diabetes Handprint (J&J Lifescan)
- Voices of Diabetes (Novo Nordisk)
Another problem with these awards is that many of the sites that receive awards “go dark.” The Sanofi-Aventis GoInsulin YouTube Channel, for example, became unavailable soon after it won the Gold Dosie award.
The Pharmaguy Social Media Pioneer Award
Nevertheless, defenders of pharma “social media” site awards insist that we must reward even the most elementary attempts that pharma is making to have online conversations despite all the regulatory obstacles that they face. I agree. But instead of having awards for the work product, why not give awards to the pioneers who have lead the way to create these sites? We can learn more from how these pioneers overcame the obstacles to launch a social media project than from the end result – even if the end result is flawed or faux. People tend to live much longer than their creations and pharma social media pioneers are no exception. They may move on to new positions and spread their influence far and wide.
To better recognize the value of these pioneers, I propose the Pharmaguy Pharma Social Media Pioneer Award.
When discussing the Social Media Pioneer Award on Twitter, at least one person (@wiltonbound) suggested that the process should be “Open to all...no restrictions. Innovation knows no boundaries.” I responded that my goal is not to award innovation, but courage in the face of boundaries! I also do not wish to get into the business of giving awards to agencies and consultants because of the inherent conflict of interest I would have. Many agencies that would qualify for such an award are my paying clients (ie, Pharma Marketing News advertisers). I probably can make a lot more money giving my clients awards, but I don’t think it best serves the interests of my readers.
What's With the Hawaiian Shirt?
Let me explain the Hawaiian shirt motif of the award. Around the time that the FDA announced it would hold a public hearing regarding regulation of pharma’s use of the Internet and social media, I started appearing at conferences in a yellow Hawaiian shirt, which was left over from a Hunter S. Thompson Halloween costume (see “Pharma Social Media Crips vs. Legal/Regulatory Bloods: Call for a ‘Peace’ Conference” for a sighting of me in the shirt at the 3rd Annual Digital Pharma East Conference). I also considered wearing the shirt when I made my presentation to the FDA at the November, 2009 meeting (see “Fear and Loathing in Washington, DC”), but out of respect for the FDA and the audience, I opted for a traditional suit and tie.
Although I didn’t wear my Hawaiian shirt at the FDA hearing, it became an emblem for standing out from the crowd, which is a necessary trait for a social media marketing pioneer. I think a Hawaiian shirt motif befits, therefore, what the Pharmaguy Pharma Social Media Pioneer Award stands for.
The Nominees Are…
I have several people in mind as contenders for this award (see the end of this post), but first let me discuss what I consider to be the qualifications for nominees.
What are the qualifications to be nominated to receive this prestigious award?
First, a nominee must work or have worked within an FDA-regulated pharmaceutical, medical device, or biotech company when he or she pioneered in social media marketing or non-branded communications or was an advocate for such. Although there are many people in agencies that are true social media pioneers and who have been involved in many pharma social media projects, only the insider has the experience we are looking for. The insider has to contend with many stakeholders inside the organization and is ultimately responsible for the project. Consultants and agencies do not have nearly as much skin in the game as do insiders.That’s about it for qualifications.
Although some pharma social media pioneers have subsequently moved on to other positions in non-pharma companies, they are still eligible for consideration as nominees for the Pharmaguy Pharma Social Media Pioneer Award.
Second, a nominee must have been a true social media pioneer. By that I mean someone who has been involved from the early days in marshaling the forces necessary to ultimately build a social media campaign. No matter if the campaign has been a failure. We often learn more from our failures than from our successes. Above all, we want nominees who have learned and who can share their learnings with us.
Third, although it is not necessary that a nominee to have experienced a “Mack Attack” such as that experienced by Novo Nordisk’s Ambre Morley (see “Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!”), it can’t hurt, especially if that person has survived and gone on to be interviewed by me (eg, “Novo Nordisk's Race With Insulin Campaign: It's Not Just About Twitter”).
The type of social media that a nominee has been involved with is immaterial as long as it is one or more of the following: a blog, a Twitter account, a Facebook page, a network (community), a YouTube channel, etc.
Who Will Nominate Candidates and Determine Who Wins an Award?
Since this award has my Twitter name associated with it, I take ultimate responsibility for who to consider for this award and who wins an award. I already have several candidates in mind (see below).
However, I also depend upon my readers and colleagues to assist me. You can vote for my nominations and write-in other candidates using the online form here. Not only your vote, but the comments you add will go a long way awards influencing me, especially if you offer details that back up your choices. I especially need help identifying former pharma people who may be working at agencies, but who did a lot of their social media pioneering while employed at a pharmaceutical company.
Ultimately, I will use my best judgment and experience to decide who is qualified to enter the contest and who wins an award. My decision is final.
There will be three winners represented by different colors: YELLOW, ORANGE, and GREEN. The first place winner receives the YELLOW Hawaiian Shirt Award, of course. Second and third place winners receive ORANGE and GREEN shirts, respectively. Sorry, there is no “Mr. PINK” as in Tarantino’s Reservoir Dogs movie.
NOTE: It occurs to me that many pharma marketing initiatives – including social media initiatives – are the result of teamwork within the organization. For example, a SM Pioneer may operate behind the scenes to support a pioneering product manager who makes the decision. Both are pioneers and should be rewarded. It is possible, therefore, that several people may share the same award. I also recognize the fact that outside consultants and agencies may have played a critical role. When appropriate, these pioneers will also receive honorable mention when the awards are announced.
Let me start the process by nominating several people that I know and have interacted with listed in alphabetically by last name. You can click on each name to learn more about this person and add comments. More names will be added as the nominations continue. Please add your nominations and/or votes here.
Nominees
For the most up-to-date list, see Nominees for The Pharmaguy Social Media Award.
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