Last week Pixels & Pills’ editor Briana Campbell had the pleasure of sitting down for a Skype chat (so the quality is a little lower than our normal, professional videos) with Dr. Darshan Kulkarni (@FDALawyers) of the Kulkarni Law Firm in Philadelphia. And while the questions answered in the conversation don’t constitute legal advice and should not be constructed as such, we were very happy to get the thoughts of a lawyer on the recent FDA draft guidance. And to have him address some questions that you all had put forth on Twitter.

Further information on some of the things Darshan touches on can be found in the following sources:

The Park Doctrine

Par Pharmaceutical versus the FDA

FDA’s Cease and Desist to Triple Flu Defense

One more time, Jonathan Richman’s handy flow chart

He also mentioned to us, after we’d turend the camera off, that the FDA uses draft guidance as a way to express their thoughts on certain issues without the rigor of regulations. There is much draft guidance out there that never becomes finalized. To us, this means that we should take the guidance for what it is – all we are getting on emerging electronic/social media platforms at this time. And maybe ever.

Do you have questions for Dr. Kulkarni? Thoughts on this conversation? Leave them in the comments and we’ll continue the discourse.

by Briana Campbell (@MsMatchGirl)

By now, you’ve all had time to review the FDA’s draft guidance on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. And you’ve had time to read the multitude of responses that came after (if you didn’t, Fabio Gratton has compiled many of them for you). And, as this is something we’ve been talking about for over two years now, you’ve probably been waiting for our response.

We were disappointed in Advertising Age’s write up calling this Social Media “Guidelines.” While this draft guidance should clear some things up for pharmaceutical companies surrounding responding to unsolicited off-label inquiries via electronic media, without being the definitive guidelines that we’ve been waiting for since 2009 (head’s up, those are not coming anytime soon, if at all), it should be used as just that – a guide. We’re not lawyers (we’ll be getting you insight from one ASAP!), but we’d guess that keeping social media responses in line with these guidelines should keep pharma companies out of hot water for at least the near future.

As recently as December 2011, we posted a piece, “Shoot First, Apologize Later: Why Pharma Needs to Proceed Without Social Media Guidelines,” that offered up the idea that, with a bit of thoughtfulness behind it, pharma could easily embrace social media platforms, not only for the benefit of their own brands, but the patients that are searching the social web for answers.

Companies that want to change, lead or influence need to take calculated risks and proceed even without formal guidelines. Often, a permissible approach results in delays, obstacles and stagnation. For companies waiting for permission, by the time they get it, it’ll be too late. Someone else will lead the pack and they’ll again be reduced to playing catch up.

That doesn’t mean to proceed without caution and strategic foresight, but it does mean the time to act is now – not at some undetermined point in the future. Consider how the U.S. Navy has embraced social media for recruiting. Realizing that conversations are happening online, with or without guidelines, they chose to not fight it and instead promote social media usage throughout the ranks.

There are loads of heavily regulated industries joining in online. Why shouldn’t pharma be amongst them?

In lines 338 through 351 (on page 10) of the draft guidance, the FDA lays out some of the thought behind the draft guidance release, writing that “the Internet has revolutionized communication” and that it has “spawned a variety of social media tools that host online content primarily created and published by users other than the intellectual property owner or product manufacturer.” Given the nature of online communities and the public’s growing reliance on the social web to gather information about their personal healthcare via internet communities, web pages, social platforms and discussion groups, it makes sense that the FDA should offer some thoughts on how their already stated policies for responding to off-label inquiries (first laid out in 1982, and restated many times after) can be applied to trends in emerging electronic media. From lines 207 through 209: “This draft guidance sets forth FDA’s current thinking on this topic consistent with Agency’s past policy statements about responding to unsolicited requests.”

Many have mentioned, and we agree, that the language, as laid out in this draft guidance, seems a bit confusing. Our friend Jonathan Richman at Dose of Digital has you covered, with a handy flow chart explaining what pharma can and cannot do in responding to these requests. We’d recommend printing it out and hanging it eye-level, for easy reference.

The internet, web sites and the social web as we know them are constantly changing, evolving and growing. This draft guidance, while maybe not the set-in-stone policy so many marketers and the pharma companies they work with – so many of whom are terrified to dip a toe in the water of social media, for fear of drowning in misunderstood or mis-handled regulations and red-tape – were hoping for, are a nice step forward in clarifying how pharma can respond to inquiries, public and private, via the web.

So. Next steps?

Let’s keep moving. Let’s keep innovating, building, growing and pushing forward as the social web continues to do the same. With an eye to this guidance, and some strategic thinking before jumping on the bandwagon, there is no reason that pharma companies can’t join finance and insurance in finding out the all the good that can happen from participating in social media.

We say, listen to the conversation, develop a plan around it and go forth. Stop running scared. Be smart and you’ll be okay.

by DJ Edgerton (@wiltonbound)

The question seems almost nonsensical at first – your Twitter followers may be really outstanding people, but they’re not organic chemists or researchers. And your Facebook fans, while devoted, probably do not, generally speaking, know how to move a new drug through the FDA approval process.

Just the same, it’s a mistake to discount your social audiences as a source for insight and innovation. In fact, a wide range of category-leading companies do just that. While social media is not as planned or controlled as a focus group, there’s potential in polling the audience when it comes to research and development – and along the way you can even benefit the very people you’re polling.

Doing it right requires a three-step plan:

Understand what you want to accomplish. In this regard, social media is no different than traditional R&D research: Don’t ask existing or potential customers anything without a clear purpose behind “the ask.” What do you want to accomplish? Are you looking for feedback on a service (such as when consumers call into the customer care center) or improvement on a product or direction for a new advertising campaign? What about new products: Are you exploring the potential for one or looking at whether your customers have a need for a product that you have not thought of?

A solid roadmap will have goals covering what you hope to accomplish and clear indications of which social channels are – and are not – appropriate. Need to demo a product? You Tube makes sense. On the other hand, Twitter may be a better fit for simple questions requiring quick feedback. And tools like custom Facebook apps offer ways to bring customers and fans into the content creation process.

Be relevant in your questions and rigorous in your data collection. A solid roadmap lays out needs and expectations, but even the best plans can go astray if your research questions don’t balance your needs with the realities of social media, which often boil down to: Don’t be boring.

Tweets sending people to a 50-question survey or requests that Facebook followers sit through six sample commercials in search of the one they like best are unlikely to go anywhere. Instead, keep things short, clear and – most importantly – be ready to monitor and take feedback from the conversations that grow out of your public questions. They can be the source of tremendous insight.

Crunch the data and don’t leave the audience in the dark. One of the unique aspects of social media is that a lot of silos get knocked down – people have a great (and sometimes unreasonable) desire to peek behind the corporate curtain and know what’s going on. This is a powerful force and can jump-start your social-driven research – people love to be treated like insiders, and promising to give them a first peek at a new innovation, a new campaign or even just a slight change in how your company does something will motivate participation in your research.

The key is: You have to deliver on your promise. If you tell participants you’re working on a new way to talk about an established product and want their input, give them a peek before it’s rolled out to the public. Not doing so is bad form in the social landscape; promising to do it and then not delivering is an even bigger faux pas.

Whether it’s a one-drug boutique company or a global powerhouse, research and development is a constant part of pharma’s product and service lifecycles. While social media isn’t a substitute for formalized marketing research, it can be a powerful, low-cost augmentation to the toolbox.

by DJ Edgerton (@wiltonbound)

Like Tom Petty sang, the waiting is the hardest part. But is it necessary for pharma to continue holding out for social media guidelines before implementing digital strategy?

With more than 75 percent of people using the Internet, social media is an important component of business communication. Yet, many pharmaceutical companies are still behind the eight ball when it comes to online interaction and taking advantage of this medium.

Back in 2009, the Food and Drug Administration said guidelines were coming, only to backtrack on that by delaying any formal rules and dropping social media from its 2011 guidance agenda. It’s understandable that without guidelines people are unsure how to proceed. But those who don’t take action now may miss out on an effective way to communicate with customers.

Change is constant. There are going to be new platforms, new users and an ever-faster pace of sharing information. The marketing mix is changing and pharma can’t afford to fall behind lest they be completely left out of the conversation. Physicians and patients are participating online, leaving a lot of untapped potential for marketers. And, the shift to patient empowerment has brought pharma-centric conversation to the social web. Shouldn’t companies – even pharma companies — be proactive in shaping messages and ensure customers have access to accurate, vetted information?

Innovation waits for no one. Companies that want to change, lead or influence need to take calculated risks and proceed even without formal guidelines. Often, a permissible approach results in delays, obstacles and stagnation. For companies waiting for permission, by the time they get it, it’ll be too late. Someone else will lead the pack and they’ll again be reduced to playing catch up.

That doesn’t mean to proceed without caution and strategic foresight, but it does mean the time to act is now – not at some undetermined point in the future. Consider how the U.S. Navy has embraced social media for recruiting. Realizing that conversations are happening online, with or without guidelines, they chose to not fight it and instead promote social media usage throughout the ranks.

Uncertainty affects everyone. One of the biggest barriers with any new technology or communication medium is knowing where to start. Pharma should look at what other heavily regulated industries are doing and gain insight from how leading companies manage compliance and the resources required to navigate a complex environment. This post notes that drug companies allocated an average of $750,000 for their digital marketing budgets this year, with digital marketing budgets currently ranging from $150,000 to several million dollars.

Even for companies who are avoiding social media due to fear of regulatory backlash should have a strategy in place to monitor what’s being said. While this one-way window limits the value of social media, it can provide valuable insight into the target audience and highlight future opportunities and pitfalls.

by Sven Larsen

#Adaptordie is an apt hashtag to sum up the teachings of digital-media pundit Brian Solis. It’s also an apt hashtag to describe the current state of affairs in the pharmaceutical industry.

Solis’s new book, The End of Business as Usual, a follow-up to the popular Engage, focuses on this need of business to change the old ways and become adept at dealing with consumers in new ways – as part of individual conversations that provide value, rather than as stoic entities that wait for customers to come to them.

Solis’s “Conversation Prism” is a hugely popular graphic that illustrates that point – that conversations are happening all at once, in a lot of different places, and digital engagement must be in the same vein.

This is hard for any old business to hear – especially one that has been made large and powerful by doing things the old ways. For pharma, with roots in old-fashioned strongholds like medicine and manufacturing, these are painful changes.

As anyone in the industry can tell you, though, these changes have begun. Just as just-in-time manufacturing took over in the 1980s and 1990s, engagement is slowly, slowly becoming the way that marketers and communicators are learning to work with their audiences.

It’s not, as the hashtag goes, optional. #Adaptordie might sound pithy and edgy, but it’s true. Imagine a pharmaceutical company that refused to have any website presence – no corporate site, no brand sites, nothing. Do you think it would be taken seriously? Do you think it would be around for long? Probably not. Yet if you tried to make that argument 15 years ago, you’d have been met with utter skepticism.

We’re in the midst of that same conversation. Convincing pharma companies of the need to join social media is a battle that is, if not won, at least well underway, thank goodness. But what to do once you get there? That’s the big battleground at present.

Yes indeed, companies would be far more comfortable without open Facebook walls, only posting links to pre-approved press releases. But the best are starting to realize that engagement is not a terrifying, ticking time bomb. (For proof, see BI’s Facebook page.)

The next step is to proactively start engaging conversations.

#Adaptordie brings to mind dramatic spear-rattling movie-montage scenes of action and drama. In practice, the current pharma “adaptation” is not much like that. It’s more like trying to lure a scared pet out from under a bed. No sudden movements, no loud noises, and let them see that there’s nothing scary that’s going to swoop down upon them.

Dramatic or not, Solis is right. If pharma doesn’t get the hang of engaging their customers in a real way – and in good time – they will, indeed, die. Slow or fast, dramatically or quietly.

by DJ Edgerton (@wiltonbound)

How much of a role does social media play in influencing policymakers? And how much of a role can – or should – marketing play in crafting those messages for pharmaceutical companies?

It’s a tough question, but before we get to it, take a moment to listen carefully. Hear that high-pitched, faint screaming in the background? That’s someone in your government relations or public affairs office horrified that you’re even asking the question.

He or she is likely twitchy because, historically, pharma’s messaging to political leaders and regulators has traditionally been a careful blend of extraordinarily carefully crafted facts, figures and key points, combined with periodic episodes of running around – typically during the final days of a legislative session – like everyone’s hair is on fire.

The fact is messaging to policymakers – whether it’s a white paper or a tweet – is fundamentally different, with its own set of rules and concerns. And those responsible for government relations in a large pharmaceutical operation are rightly concerned that such messaging should be tightly controlled. So against that backdrop, does the sometimes wild-west world of social media have a role?

Increasingly, the answer is yes – because it works.

Elected officials are turning to social networks both as a channel to communicate with voters and as a way to stay informed about constituent concerns. Fleishman-Hillard reports that, in Europe, there’s a rapid uptake of social technology by members of the European Parliament.

Findings included:

• 69% of members of the European Parliament (MEPs) use social networks such as Facebook to communicate with voters;
• 34% are now on Twitter, compared to 21% in the first report;
• 44% are using YouTube as a means to reach their constituents
• Slightly over one-quarter of MEPs are using blogs as a means to express their opinions directly

In the U.S., the Congressional Management Foundation released a survey of members of Congress (MOCs) and their senior staff on how MOCs communicate and what matters to them.  When it comes to social media, they were asked the question “In your opinion, how important are the following for understanding constituents’ views and opinions?” Findings included:

• Of the 14 choices, traditional means such as events and town hall meetings took top spots, but Facebook landed in 7th place (with 64% saying that Facebook was either Very or Somewhat Important), above Twitter and YouTube which were 11th and 12th, respectively.
• Conversely when asked to rank the importance of various vehicles for conveying the opinion of the MOC to constituents, 74% of MOCs ranked Facebook as either Very or Somewhat Important.

What do these findings mean? It’s easier to say what they don’t mean: They don’t mean that social media, owned by the marketing department, will abruptly take on most government-relations messaging anytime soon – it’s an entirely different world, requiring different expertise, and the most crucial conversations and relationships are still at the personal, one-to-one level. However, the research is also pretty clear: Politicians are embracing social media, albeit slowly, and they are using it to take the pulse of their constituents’ concerns.

While pharma’s marketing-based social media communicators may never be in the driver’s seat for this messaging, we shouldn’t be surprised if, increasingly, they’re asked for directions along the way.

As we keep talking (and talking and talking) about and waiting (and waiting and waiting) for FDA Guidelines for social media usage, we thought it would be fun to visit this video, from nearly two years ago.

Do you remember this time? Are you still waiting for guidance or are you pushing the boundaries without it?

In our final interview from the Digital Innovation for Pharma Conference, Darshan Kulkami, principal of the Kulkami Law Firm talks about some of the latest news regarding social media and compliance and what it means for the pharma industry.

by Jason Brandt (@jasondmg3)

1. I don’t understand any of this stuff.
2. Who has the time to really use this stuff anyway?
3. No real business can afford to have employees wasting their time on this stuff when they should be busy working.
4. It’s just a geek thing. Nobody with a life really uses this stuff.
5. It’s just a kid thing. Nobody over 20 really uses this stuff.
6. Even if this new stuff has some applications for some industries, but in healthcare, it’s just too difficult. It will never work here.
7. Even if we wanted to see if this new stuff could work here, we can’t try it yet. We have to wait for the FDA to explain exactly what we can and can’t do.
8. Even if we did try this new stuff, who would own the project? IT? Marketing? Communications? We can’t all try to share it, it’ll be a disaster.

Raise your hand if you’ve heard someone say that about social networks, smartphone apps, blogging or any other type of social digital technology over the last few years.

Now, if you’ve been in this industry over 15 years, look at that list again… and raise your hand if you heard someone say that about websites in the mid-1990s.

The more things change, eh?

As funny as it sounds, people were scared to death of websites – once they stopped scoffing at them. They’d waste employees’ time, they’d never be accessible to most consumers, they’d invite a crippling deluge of adverse event reports from the fanatics who would find them, and the FDA would shut the whole company down if you tried to say anything anyway.

The double-edged sword that breakthroughs carry (in communication technology or anything else) is that they are entirely unformed. They do not come with guidelines. They do not come with user manuals. You can’t always tell which will catch on. You can’t always tell how people will use them. You can’t always tell what next-generations they will spawn.

This is uncertainty. This is change. This is movement.  This is scary as hell.

But the thing is, it’s not. It is not uncertain, it is not movement or change. It is not new. It is the exact same argument about the exact same ideas – just with a new specific target.

Healthy skepticism is healthy. It can keep you from wasting time, money and resources. It can keep you asking questions. It can keep you thinking critically and strategically.

But unhealthy skepticism is paralyzing, debilitating, deadly. Today, you’d laugh at any company who thought having an online presence was a waste, or who wouldn’t give their desk-based staff internet access. It would be ludicrous.

So, how do you keep the balance between healthy skepticism – and asking the same fear-based questions from decades past?

Here, we get our hands dirty with new technology. We take it apart, play with it, figure out what we’d like to have it for ourselves, and start to piece it into our plans. But we don’t throw out what we’ve got that’s already working. Movies didn’t disappear after TV, and TV hasn’t disappeared because of the internet. The new pieces – the ones that last – learn how to play with the old ones, and vice versa.

How do you stop asking the same old questions?

by DJ Edgerton (@wiltonbound)

What do Lady Gaga, Arnold Schwarzenegger and Charlie Sheen have in common? They’re some of the most popular celebrity masks for party revelers this Halloween season. While industry luminaries may not dress up for tricks and treats, many pharma brands are hiding behind their own masks, limiting the ROI in their digital initiatives.

Pharma hides behind the mask of regulatory uncertainty because the FDA has been iffy on rules for social media. Rather than looking at regulatory guidance for other mediums and instituting their own social media policies, many industry players have taken the stance of “there’s not much we can do without formal guidelines.”

While there is some “damned if we do, damned if we don’t” mentality – particularly as Facebook’s open pages and comment policy has increased concern about regulatory ramifications – remaining stagnant in the face of fear doesn’t serve stockholders or customers well.

It’s time for pharma to accept that social media is where their customers are. It’s the gateway to authentic conversations and brand communications and the industry needs to figure it out – whether that’s defining its own policies or taking calculated risks. Hiding behind the mask of “no one is telling us what to do” is no longer acceptable.

Pharma also hides behind the mask of “do what the other guy is doing.” There’s a lot of pack thinking in pharma marketing. While innovative creative in advertising comes along pretty regularly, true innovation at the strategic level is rarer to find.

With the expiration of about $130 billion in patented products over the next several years, pharma needs to stop playing follow the leader and devise strategies that result in better portfolio management. Reliance on blockbuster products has been what everyone has banked on, but current conditions cry for a change in business as usual.

The doctor’s role as gatekeeper in the prescription path has diminished as the empowered patient takes the lead. Patients are turning to apps and social interactions to learn about their conditions, treatment and care. There are many digital touch points, but if organizations want to break out of the clutter, they can’t operate under a “me too” philosophy. They need to innovate, take risks and adopt new ways of interacting with their target audience.

Pharma needs to come out from behind the mask of corporate-speak. Modern branding and marketing need authentic, human voices front and center. That may be scary for traditional pharma marketers who hide behind the mantra of “legal would never let us do that!” or “we’ve never done that before!” But it’s time to be bold and open the kimono, whether that’s using social tools to strengthen connections between sales professionals and physicians or pharmaceutical companies and patients. Distrust and skepticism have long plagued the industry but authentic, open communication via digital tools can change that dichotomy and increase transparency and trust.

Pharma can no longer afford to hide behind the mask of paid media. Yes, it’s easier for a brand manager to spend X with a historic return of Y on traditional, broad-scale paid media, rather than to consider the long-term brand equity in smaller, more targeted campaigns that rely more on social or earned media.

But pharma needs to take the time to clarify its media goals and optimize its presence on the social Web. Earned media – retweets, blog posts, Facebook comments, etc. – can drive success for overall marketing campaigns by further empowering the patient to raise awareness, create or support interactions and impact emotions. The new model requires a patient-centric focus that requires risk, effort and innovation.

While others are donning masks for Halloween, pharma should get in the spirit of facing their fears and get comfortable using digital technologies to connect with patients and market effectively.

What mask are you hiding behind?