The most recent video is called “The Paradigm of Awesome!” and it is, well, awesome. Plant manager Heidi adopts a talk-show format for the monthly progress update, in which she talks about how February is “our month of awesome.”

“The paradigm of awesome is all about ideation!” she enthuses. “Ideation is like thought plus! It is about breaking down the barriers that keep the lower ranks from ideating properly! Old-fashioned thought is no longer acceptable at Trustus Pharmaceuticals!”

There’s more about breaking down silos, etc. At the end of it, you get to see the engineers’ and scientists’ reactions to the talk. Needless to say, it’s not enthusiastic and I share their feelings.

You may have seen an article making the rounds: Rise of the New Groupthink.  The author examines how solitude is out in the corporate environment, and the truly creative are introverts who do their best work in solitude and privacy.

This is putting a broad brush on things, but I will hazard a guess that a lot of scientists fall on the introvert scale, and their marketing brethren fall on the extrovert scale. Think about it.

By the very nature of what they do, scientists have to spend a lot of time by themselves. If they are running a protocol in which they are spending lots of time under a fume hood, well, a propensity to be inside one’s own head for long periods of time is helpful in that line of work. The results of the experiment are discussed in a group, but every older lab I’ve been in offers some spot where a scientist can go hole up and write. Or they can work at home. It’s like doing their masters or doctoral theses all over again.

But in the newer labs, this space seems to be disappearing. Just as their marketing colleagues inhabit open offices, the scientists are inhabiting open labs. Novartis’ “Lab of the Future” is just one version of this. Yes, many aspects of drug development are a collaborative occurrence – “But it’s one thing to associate with a group in which each member works autonomously on his piece of the puzzle; it’s another to be corralled into endless meetings or conference calls conducted in offices that afford no respite from the noise and gaze of co-workers,” as Susan Cain, the author of “The Rise of the New Groupthink” tells us. (The irony in Novartis’ Lab of the Future concept is that in my visits to NIBR up in Cambridge, I saw nooks within the labs for scientists to be by themselves – and Novartis has been experiencing more early pipeline successes than most.)

I fear that pharma, in following the Lean/Six Sigma, kaizen event style of management, may be sacrificing its scientists on the altar of the new groupthink – at the very least, crippling those whose insights could be moving the company’s pipeline forward. Only 35 new molecular entities were approved in 2011, and although pipelines are improving, it’s not going to be fast enough.

Will the pendulum swing the other way? It has to. For every scientist that can thrive in the open environment, there are many more who are barely tolerating it. Maybe a happy medium can be found – and for the future of the industry’s sake, I hope it can.

At Echo Torre Lazur, they took a somewhat different approach this year to give us a snapshot of what the agency has experienced, and we think it was pretty darn funny:

Going the XtraNormal mile …

Meanwhile, GSW Worldwide sent us another box:

Will it go boom?

Thankfully, it didn’t contain anything explosive, unless you consider their creative to be so …

Palio, a sister agency to GSW, sent us a musical homage to Barry Manilow and the Manny Awards:

Oh Manny, I need you tonight …

But we’ll be getting our heads down now, processing all the entries that have come in so far, and prepping the voting Website. If you’re an agency president, CEO, managing partner, or creative director, you get to cast your vote and weigh in on the creative that YOU think is outstanding (just don’t vote for your own stuff, you’ll be wasting your vote, honestly).

It will all culminate in a few months at the Manny Awards, April 24, 2012, at Pier Sixty in New York. Will I see you at the party?

(Incidentally, I will be at the ePharma Summit on Tuesday, Feb. 7, Tweeting and blogging, if you want to say hello. If you don’t know what I look like, go to my Twitter profile.)

I received a Tweet this morning from an account director from a digital advertising agency:

@ChristianeTrue I had to share this with you….talk about pharma out of the box. youtube.com/watch?v=1PblYO…

The video linked to is this one:

Follow the Wings

As a crowd gathers on a Manhattan street, they (and we) get to view an office building become the home of two frolicking Lunesta brand icons – giant green moth/butterflies that pop in and out of various windows, spreading their somnolent pixie dust or maybe attaching themselves to insomniacs. We just know the rooms they’re in because the windows flash green. The building also transforms into a glowing fairyland straight from a 1970s black light poster before the giant moth/butterly flies over the world and swoops down to Manhattan again.

Far out, man!

The light show/insectile invasion is to promote a free game, also called Follow the Wings, in which you can make the pretty moth/butterfly gather coins and flowers, while avoiding crows and hawks. It’s all for a good cause: “LUNESTA will contribute $1 to CARE the first time you play every day, plus every time you share with a friend (one share per friend). Our goal is to raise $100,000 for CARE,” the Website says.

There’s genius in this. Insomniacs spend many hours on the Internet (I should know, I am married to one). A game like this one, with very undemanding play, can help fill the late-night/early morning hours. Meanwhile, there’s all that Lunesta brand imagery and ad copy prominently displayed next to the game. This is a totally perfect match. Added bonus: a charity benefits.

The whole purpose of the light show, which was done at the end of October, was to drive awareness around the charity element of the campaign, I am told. “The client was open to it, which was great,” says an unnamed account executive at the agency that came up with the video idea. They wanted something innovative.”

The agency was pleased that Sunovion wanted to do something so much out of the typical pharma comfort zone.  “The moth has a really high brand recognition value, and to do something a little bit different was great,” another executive says.

Now excuse me, I have more coins and flowers to gather.

Doughnut burger served at the 2010 Olmstead County Fair in Minnesota, via Jonathunder on Wikimedia Commons. At the Indiana State Fair in 2010, a vendor of similar burgers was quoted as having come up with the concept after seeing Paula Deen "do it on TV."

Friday, while on Facebook, one of my friends posted this little item from the iPad newspaper, The Daily.

Paula “put a burger and bacon and a fried egg between two donuts” Deen rumored to have type 2 diabetes? It would have been more shocking if she didn’t. The cuisine featured at her restaurant in Savannah, The Lady and Sons, as well as her show on The Food Network, has staggeringly high amounts of fat, sugar, and salt. Come on, when my own mom, the queen of baked goods and goddess of buttercream, disdains Paula Deen’s dessert recipes as being too sweet, something is definitely wrong here.

So, I went on Twitter with this smartass Tweet:

ChristianeTrue Jan 13, 11:14am via HootSuite
Paul Deen: 1.Promote fatty, sugary cuisine to TV audience. 2.Promote Novartis diabetes Rx to same audience. 3.Profit! ow.ly/8stdN

A bunch of us (including Matthew Herper of Forbes, Brian Reid of WCG, and Sally Church of Icarus Consultants) started a frenzy of speculation about which Novartis drug it could be – and we quickly concluded that it couldn’t be Novartis, as their main diabetes drug is not approved in the United States. Novartis actually sent a correction to The Huffington Post, confirming that they were NOT working with Ms. Deen.

Eventually, we started to speculate that it could be Novo Nordisk. I sent an e-mail query to Novo Nordisk’s corporate communications people on Friday, but never heard back from them. Come on, folks, I am not that hard to find.

Now, today, Paula Deen has announced she has type 2 diabetes and she is working with Novo Nordisk, in a campaign called “Diabetes in a new light.” The Novo Nordisk Website copy is punctuated with Ms. Deen’s folksy patter – “ya’ll” and “ya” in abundance – and features lighter versions of her famous artery-clogging recipes. And there are tie-ins to her brands – the version of the Lady and Sons lasagna recipe features “Paula Deen’s House Seasoning” and “Paula Deen’s Seasoned Salt.”

The recipe itself is rather a horror – besides parmesan, nonfat ricotta, and reduced fat mozzarella, it includes low-fat cottage cheese, reduced fat sharp cheddar cheese, Gruyere cheese, and reduced fat cream cheese. Oh, and bell peppers. And no garlic. If I offered this to my Italian relatives, they’d be insulted.

Back in August, celebrity chef Anthony Bourdain took Ms. Deen to task over her cuisine, calling her the “most dangerous person to America.” But he says he is taking no pleasure from the news. But this quote is classic: “When your signature dish is a hamburger in between a doughnut, and you’ve been cheerfully selling this stuff knowing all along that you’ve got Type 2 Diabetes … It’s in bad taste if nothing else.”

And seriously, Novo Nordisk? Seriously? I know you have a great program going with race car driver Charlie Kimball, who has type 1 diabetes. And that you’ve extended that sponsorship program for another year, which is also really great news. Type 1 diabetes can be a devastating diagnosis, and for children and young teens, Charlie Kimball is a great example of success.

But Ms. Deen’s blatant disingenousness about her condition (that she may have been diagnosed as long ago as 2008) and that her own cuisine may have contributed to her condition, plus her recipes shilling her own spice mixtures…seriously? She is not the example I’d want to be holding up as a marketer.

The look on my face right now is the same as Jonah Hill’s as he’s offered a bite of her cheeseburger meatloaf. “I’m not eating that,” he declares.

Good for you, Jonah. I’m not eating that – or buying Ms. Deen’s transformation into an oracle of healthy eating, either.

PI has announced the company has formed an exclusive strategic alliance with WorldOne, the largest healthcare data collection company in the world. The move creates one of the largest and most focused market research opportunities for medical professionals and life science companies in the United States, PI leaders say.

“Since we have one of the largest healthcare professional networks globally and the largest in the United States, naturally we were attracted to WorldOne’s established expertise in conducting and managing research, and to their global research footprint,” says Donato Tramuto, CEO and vice chairman, Physicians Interactive Holdings, which develops mobile and online clinical resources and solutions for healthcare professionals.

Headquartered in Marlborough, Mass., PI has built the largest network of online and mobile healthcare professional relationships in the United States, reaching more than 875,000 physicians, nurses, and allied health professionals in all major specialties, PI leaders note. The network includes what company executives describe as a premier, verified panel of more than 200,000 of the busiest and most sought-after physicians in the country.

Through the alliance with WorldOne, these medical professionals will have an immediate opportunity to share valuable insights with life science companies and participate in online and mobile market research that can guide and improve the quality of patient care.

“Essentially, for the healthcare research market, it’s the best combination in terms of our healthcare professional network and WorldOne’s expertise in research, design, and execution,” Mr. Trumato says.

Peter Kirk, CEO of WorldOne, says both parties immediately recognized the “exceptional business opportunity” to create the largest and highest quality market research network in the United States.

“We made sure to build a fully integrated solution, for both our clients and health professionals,” Mr. Kirk says. “More importantly, when combining PI’s network with WorldOne’s U.S. healthcare panel, we will reach a very impressive one million healthcare professionals. A significant part of this panel is 300,000+ AMA-verified physicians in the U.S. Market researchers now have access to the largest panel of practicing U.S. physicians ever assembled. This is a big step forward for WorldOne, Physicians Interactive, and the market research industry.”

Mr. Trumato says that life science companies want to build relationships with healthcare professionals in order to better understand how they’re practicing and treating patients, and what their greatest needs are.

“This can include everything from insights into medical conditions, treatment, needs for drug R&D, prescribing habits, and so on,” Mr. Trumato says. “Typically, WorldOne receives requests that include a variety of research on medicines such as concept testing, ad testing, naming, awareness, and trial & usage.”

While PI’s initial launch focus is on the U.S. market, Mr. Trumato says the company intends to expand its offerings internationally as it combines the global research capabilities of WorldOne with its Global Healthcare Network.

But Donato Tramuto, CEO and vice chairman of Physicians Interactive Holdings, believes providing physicians with the ability to save time while more effectively treating their patients does not necessarily require more innovation. The answer, he says, is integration.

PI’s work to provide that integration has just received the attention of – and a big boost from – Merck’s Global Health Innovation Fund, which has agreed to invest $17 million in the company, which develops mobile and online clinical resources and solutions for healthcare professionals.

Mr. Tramuto, one of the company’s founders, says he recognized the company’s growth over the last two years would attract investors to partner with PI to accomplish several goals – including to continue expansion of its product portfolio and to identify products and services that are needed by physicians at the point of care.

“These dollars will be partially used to continue to build on that strategy,” Mr. Tramuto says. “We are significantly moving forward in extending the ability to access these services on the web, the mobile, and the EHR.”

In addition, PI has defined several growth initiatives to deal with what company leaders consider the mature products within pharma. “[There are] thousands of mature products within pharma that have yet to go off patent, yet they don’t have, if you will, sales rep attention, and we feel there is a unique opportunity to capitalize on that. We will also use those dollars to optimize our user experience.”

The money from the investment will also be used to continue with the company’s acquisition strategy that Mr. Tramuto hopes will bring additional scale to the organization. “To have an organization like Merck’s Global Health Innovation Fund working with us – not only do they bring the dollars, but we have another voice that we can lean on,”Mr. Tramuto says.

Merck’s GHIF has taken a minority position, meaning the company also has one seat on PI’s board of directors. However, the partnership will not impact PI’s realtionships with other pharma companies, Mr. Tramuto says, because of the minority position. However, Merck’s global reach, along with its analytical firepower and insights, can benefit PI in moving forward with new solutions.

“They have vetted many of these companies that we are now going to be looking at,” Mr. Tramuto says. “They have other companies within their portfolio in terms of the innovation fund that I think are gong to be very valuable to us in terms of partnering or working together or selling services back and forth. They bring another level of extended talent. We’re 275 employees, and having that additional talent that I can lean on is very exciting.”

Mr. Tramuto’s approach to moving forward with new solutions in the mHealth age is to ask which benefits the company can provide to a physician at all stages of his or her encounter with a patient, including before or after a patient visit. Because PI will be looking at strategies not just from a mobile or web perspective, but also from an EHR perspective, Mr. Tramuto says he expects the company to also undergo a re-branding in 2012 with the tagline: “The power to do more.”

“We want to give healthcare professionals the power to do more, so we will continue to optimize and brainstorm our services and products at the point of care to get their time back to be more effective with the patient,” Mr. Tramuto says. That power can take the form of  reimbursement or compliance services, e-education, or the company’s current work with sample vouchers and coupons.

Providing access to such tools via mobile devices, the web, or through the EHR can impact physicians’ ability to practice more efficiently, Mr. Tramuto says. PI is looking to build the ability to allow physicians to order samples, vouchers, or coupons without having to leave their desks and access education materials instantly at their fingertips. The social aspect is also important, PI leaders believe, and the company is looking to embed a social media ability within its model to allow physicians to interact with each other. The goal is to provide a system that provides credentials and validates the physicians or experts who participate in the function.

Mr. Tramuto says the company is assessing a variety of its new solutions under the philosophy to think big, start small, and execute quickly. “We’re thinking big, but over the next six, seven weeks, we’ll narrow this down to two or three very significant additional products, which might be an acquisition, or we might build inside,” Mr. Tramuto says. “My goal is to double the revenue in the next 36 months. We doubled it in the first three years.”

Why is pharma so interested? As the sales force becomes much more compressed, as the generic intrusion takes on greater momentum, and as healthcare reform continues to kick in, the alternative is to find a lower-cost, but effective model to reach healthcare professionals. The aspect of achieving the ultimate goal – better healthcare – is also attractive, Mr. Tramuto says.

“Yes, we’re commercializing this stuff, but at the end of the day, I can put my head down at night knowing that if healthcare professionals are using this, and they have data at their fingertips, and they can get information about different diagnoses, and they can have the ability to help patients go and get their medication because [there are] coupons that are being automated from our system right down to the pharmacy, it’s going to provide for high-quality, safer, and more effective and efficient healthcare outcomes,” Mr. Tramuto says. “That’s what motivated me, and that’s what I think motivated Merck to see this as they’re now involved in a healthcare partnership.”

In moving forward, Mr. Tramuto says the company will make an announcement in the coming weeks about an agreement PI has signed with an EHR company.

“People says that physicians are not ready to accept technology – that’s a bunch of rubbish,” Mr. Tramuto says. “We haven’t caught up with physicians. Technology hasn’t caught up with what they want.”

Currently, when a physician uses an e-Rx system to prescribe a drug, he or she has to get out of the system to access other data, including drug safety information, and to obtain vouchers and coupons. PI’s intention is to integrate these tools so that when a drug is entered in the e-Rx system and the EHR system, all of the information will be readily available.

“That’s going to be available on the EHR, on the mobile, and on the web system,” Mr. Tramuto says. “I don’t think innovation is our problem anymore. There’s a lot of great innovative ideas out there … What we intend to do is to really focus on integration in those key areas that really involve drug usage.”

So when they both visit the pharmacy to pick up their prescriptions, they should not be receiving the same, generic package of educational material about managing their condition and adhering to their medicine, leaders at Catalina Health believe. Rather, they believe their new Health Consumer Journey approach will help drive medication adherence and create healthier outcomes for patients, who will better understand their “individual health journey” as a result.

With one of the world’s largest privacy-protected, propriety pharmacy databases, Catalina Health is developing customized patient education materials based on certain factors about health consumers – their ages and gender, whether they are new to a medication, and whether they have been managing other conditions, for example.

“Our message is delivered at the point of sale at a pharmacy counter,” explains Renee Selman, president, Catalina Health. The company uses a patent-protected methodology that de-identifies a consumer; the company will know age, gender, and other factors through the NDC but will not have access to a patient’s name or address.

In addition, the company has studied patient attitudes and emotions related to thirteen disease states. This helps the company design varying messages to consumers: the company can reach a “healthy optimist” who will attack his or her disease as well the “unconcerned invincible,” who might not care much about managing the condition at all.

“From a data perspective, we understand a lot about the diseases, and we understand the NDC, so we know what kind of medications they’re on,” Ms. Selman says. “To just take it further, and to put more investment into understanding segments and attitude so that you can do a better job for the person on the end of that communication – to me, it’s consumer centric marketing 101 in a lot of ways.”

The company has applied data about the patient attitudes and emotions to the new Health Consumer Journey. For example, a “Novice” might receive a different type of message than someone Catalina defines as a “Moderate Experienced” patient (to see more patient categories and read their descriptions, visit catalinamarketing.com/health/patient-journey.

“If somebody’s a novice, they potentially have a lot more information needs about the condition itself, and they’re just getting used to the fact that they have the condition, and so they might need a lot more general information,” such as information about how they are to take the medicine and the adverse events associated with the product, Ms. Selman explains. “If somebody has been living with the condition for five years, they maybe have less concerns about adverse events because they’ve been taking it for a while,” she says. “But to keep them compliant, you maybe need to take it to the next level,” which could include providing more information about the condition or reminding the patient about the benefits he or she is receiving by taking the drug.

“It would just be a little bit more involved of a message,” Ms. Selman adds.

The new, deeper insight provides segmentation information in which the company has invested over the last few years, Ms. Selman says. “We’re tying in not only the data, but also the emotions and attitudinal segmentation possibilities to make these messages even tighter,” Ms. Selman says.

Consumer centricity comes naturally to Ms. Selman, who has worked in brand marketing, device marketing, and several consumer-driven projects over the course of her career. “It seems natural, but you have to truly be holistic about who’s on the other end of the communication, and you need to decide that you’re going to run your business to help them – and to help them on their journey, and not be hyper-focused on what big-brand pharma wants or what somebody else wants,” Ms. Selman says. “Think about the person on the end of the communication and do the best you can for them because that will drive a better outcome; that will drive better information.”

Non-adherence to prescribed medications can cost approximately $290 billion annually in total direct and indirect healthcare costs, Catalina leaders note. The personalized patient education that Catalina delivers to consumers at the pharmacy point-of-care provides a solution to improve adherence and increase brand profitability, they say.

Ms. Selman says that helping patients control their diabetes, hypertension, and other chronic illnesses can reduce the chances they will land in the hospital, which carries implications for the overall healthcare system.

“Obviously, we’re pretty excited about this model, and we just feel that we’re able to incite behavior change because of this better educational messaging, and we feel this will bring significant value to the manufacturing partners, big pharma that we’ve worked with for years, retail partners, and other partners that might be in the healthcare chain,” Ms. Selman says.

Mike Myers, president of Palio, says there are about 100 apps on the wiki now – branded and unbranded, for consumers, physicians and other healthcare workers, and caretakers.

“We have watched the explosive growth of apps in the consumer world and at the same time have seen a growing number of pharma and healthcare companies develop their own apps,” he says. “Makes sense, consumers on all sides want digital content that is targeted directly to what they are interested in, exactly when they are interested in consuming it.”

Each entry on the wiki gives a description of the app, who it is sponsored by, who it was developed by, and the relevant links to the iTunes, Android, and Blackberry app stores.

According to Mr. Myers, if it’s a healthcare app, it’s welcome on PharmApps – even if it wasn’t developed by Palio or a sister InVentiv agency. “If one of our competitors has 50 apps they’ve built, so be it, they get to go up there,” he says. “It’s really going to be a wiki that we’re just managing.”

The only thing that will be censored is profanity, he says.

Within the next few months, PharmApps will have an accompanying blog, another place where people can discuss apps on the site, Mr. Myers says. The blog will have a “featured app” of the week or the month, and writeups about events in mobile app development. “It will all be about mobile and apps,” he says.

Although the wiki has Palio branding, “It is not a revenue-generating thing, at least not right now, there are no plans along those lines,” he says. “It’s all about providing a resource to pharma and people interested in healthcare about what medical apps are available out there.”

Mr, Myers says the content will be consistently updated, on a “reasonably regular basis.

“We did it because we know there are thousands of apps out there, there is no centralized place to really look at health and see what people are doing, so we built a resource.”

Mr. Daly joined the Medical Economics sales team in 1962 and worked there for two years before taking ad agency position at Klemtner and Robert A. Becker. He returned to the Medical Economics Company as publication manager of RN, which he turned into a successful title. The Medical Economics Company grew and was acquired first by Litton and then International Thompson. Mr. Daly became publisher of Medical Economics and eventually the CEO and chairman in 1981.

During Mr. Daly’s tenure, he was responsible for expanding the company with successful new products including Drug Topics and PDR. Under his guidance, the Medical Economics Company became the industry’s leading publisher, and Medical Economics magazine became the leading title. He retired in 1991.

Mr. Nickel spent 40 years in the medical advertising industry. After serving in the Air Force, he became a market research analyst at Pfizer, where he worked as a professional sales representative, marketing research manager, assistant product manager, and product manager. He then moved to a position at USV before moving to the agency side at J. Walter Thompson.

Following JWT, Mr. Nickel joined Sudler & Hennessey before helping co-founding Dorritie & Lyons in 1979. In 1994, he was named president and chief operating officer of the firm, now called Lyons Lavey Nickel Swift, and became chairman and CEO before retiring in 2008. During his time at LLNS, he was involved with launching blockbuster brands like Celebrex and Zoloft and the creation of the TWBA network.

Mr. Smith began his career as a designer at Sudler & Hennessey in 1951, working on Ayerst’s Inderal. He became art director and then creative director at the shop before joining Herb Lubalin to found Lubalin, Smith, Carnase, in 1967. In 1980, he returned to Sudler & Hennessey, where he created advertising campaigns and served as a mentor. His design credits include the PBS logo and Lucky Strike “Eve” package. He died in 2004 at age 79.

The inductees will be honored February 7, 2012 at a black tie awards dinner at the Pierre Hotel in New York. For tickets, visit www.mahf.com or email david@mahf.com.

Much of the apparent ado delaying FDA’s social media draft guidance is likely attributable to the agency’s concerns about user generated content. User generated content can take many forms, depending on the social media platform, and might include narrative written content, video, audio, combinations of these, or even other formats. And user generated content can appear in a number of different technology platforms that might be offered by a social media site sponsor, such as a pharma company. These social media platforms could conceivably range from the incontrovertibly promotional to the unquestionably educational, with gradations of each along the continuum between them. Moreover, user generated content, like other online content, has the opportunity to go viral and thus cannot necessarily be restricted to the platform on which it originally appeared.

Analytically, however, user generated content seems substantially  distinguishable from what we traditionally understand to be “push” advertising or promotion.  It is true of course that in a format that is unquestionably promotional, user generated content, depending on its content, may well take on the regulatory character of its “host” medium. In other words, if the host site is transparently promotional, it may be difficult to argue that the user generated content, no matter that it originated with someone other than the product manufacturer/Website sponsor, is not properly regarded as advertising and promotion by the sponsor.

Conversely, however, in a social media platform that is unquestionably educational, and thus beyond FDA’s reach to begin with, on what principled basis would the user generated content be regarded as manufacturer “promotion” regardless of its content? Put differently, why should user generated content be treated as promotional in this context? The user generated content in this circumstance should not ordinarily be interpreted as the manufacturer proposing a commercial transaction, which is one main determinant used by the U.S. Supreme Court to define commercial – promotional – speech.  If the user generated content is non-promotional and is thus not deemed to be advertising or promotion disseminated by the pharma company that sponsors the social media platform,  then the representations could in no event amount to promotion, as to the sponsor, that is off-label, unsubstantiated,  lacking in fair balance, or otherwise in violation of any FDA requirements.

Most publishers do not ordinarily assume liability merely by providing a forum for the dissemination of information. Congress even enacted a law that protects internet service providers from precisely such liability for transmitting communications that they do not control. Why should a pharma company that merely provides a non-promotional educational platform for user generated content be treated differently? Regrettably, the pharma industry and others who have an interest have not articulated a comprehensive regulatory, policy, or constitutional rationale for treating user generated content in this context as non-promotional thereby leaving room for FDA to muddle its own way through the problem.

It behooves industry to develop such a thought-piece and to make the case strongly that user generated content, at least when it appears in the context of an otherwise non-promotional social media platform, is itself non-promotional and therefore beyond FDA’s jurisdictional reach. That would be an important contribution to the debate.

To be sure, just because user generated content originally appears in a non-promotional social media context, this would not necessarily insulate the  manufacturer if it republished – e.g. “re-tweeted” – this content in other, more clearly promotional contexts. But that is simply application of the well-established rule that context determines meaning that FDA itself has adopted, say, in its draft risk disclosure guidance and elsewhere. What something means is unquestionably affected by the context in which appears. Taking content that may be non-regulated in one context and repurposing it elsewhere does not carry with it automatic immunity from FDA regulation. Nor should it. Just as in the real estate world, where it’s all about “location, location, location,” so too in the social media world should it be all about “context, context, context.” And in an unquestionably educational context, with the right kind of disclaimers, user generated content should not be regarded as promotional and thus subject to all of FDA’s many restrictions. In this circumstance, at least, reason, common sense, and the law all dictate that the user generated content not be regarded as promotional and as not, in itself, converting the social media platform into an FDA-regulated piece of “push” advertising.