It finally happened! The FDA released guidelines that actually mention social media, or as they refer to it: “emerging electronic media.” Of course, the guidelines are for responding to unsolicited requests for off-label information through any medium, but it’s a start. Or is it? PM360 asked experts to comment on the guidelines released this past December as well as touch on a few other subjects: Can pharma really afford to wait for (or even expect) a full set of social media guidelines? Who has to move first: the industry or FDA? If it is the industry, how do we do it? And how can pharma protect itself from possible FDA backlash without more guidelines in place? Is there anything pharma can learn from past decisions made by the FDA?

The opinions expresses by the authors in the Think Tank section are their own and do not necessarily reflect those of their affiliated companies or organizations.

Eric Pilkington

Eric Pilkington SVP, Digital Strategy
Torre Lazur Healthcare Group

Eric.Pilkington@mccann.com

In November 2009, I attended the FDA’s Part 15 hearings on social and digital media as an agency panelist. It was an opportunity for folks like me to offer up our opinions and experiences in an attempt to guide the FDA into and through the world of social media, and perhaps to make a compelling case as to why pharma should be able to play cautiously, on Facebook, Twitter, YouTube and other social channels. The fact remains that patients, caregivers and even physicians, often turn first to the Internet in their quest for information, opinions and support. I have always argued that the healthcare industry, its marketers, and even the FDA have a social and moral obligation to provide medically relevant and accurate information to those who seek it. That is not to say that social media should be used as another outlet to sell. Quite the contrary. It is an opportunity for pharma companies and brands to listen, understand, and foster connections with and between people. It’s also an opportunity for drug companies to monitor conversations, be informed, and set the record straight when misinformation is given. This goes well beyond brand building. Rather, it’s a new form of communicating important medical information to those who need it the most.

After two long years, the FDA released its draft guidelines on social media and the pharma industry this past December. This 12-page document primarily focuses on conversations tied to on- and off-label medication use. While it does little to clear up confusion, it is, I believe, a modest step forward. Though not a comprehensive set of guidelines, it represents the FDA’s progress towards a broader, more definitive guide in the use of social media platforms by the pharmaceutical industry. Further, it shows that the FDA is starting to address and incorporate social media into its thinking.

Many colleagues, however, feel that the FDA’s position around social and digital media remains ambiguous. And to some degree, it is (after all, it’s the FDA!). Despite the sentiment and FDA’s intent, the rules for us, at least for the moment, haven’t changed. As healthcare and medicine become more and more socially driven, pharma needs to put its fear of social media aside, exercise some common sense, and become more social. That is not to say that pharma brands can be like Nike; pills won’t make us run faster or jump higher. As such, we can’t allow others to claim that they will. Definitive rules may take another two years to come or may never come at all. But we can’t use this as an excuse to sit on the sidelines. Social media in healthcare has intrinsic benefits for patients, physicians, caregivers, and pharma. This is a fact that can’t be ignored.

Craig DeLarge Director

Craig DeLarge Director, Healthcare Professional Relationship Marketing
Novo Nordisk

cdrg@novonordisk.com

I think we see that both the FDA and the industry are moving forward with social media. The fact is that brands throughout the industry are providing value with social media programs of various types. (The Dose of Digital Social Media Wiki provides a comprehensive list: http://bit.ly/gP04O.) We are also beginning to see FDA issue select guidelines on aspects of social media and its use. This process will never be as fast as we like, but what we have is more than what I thought we would get. I think we have to remember this is a dance. It is not unlike past dances with FDA over websites, search marketing and DTC. I think we have to stay focused on providing our customers value in a compliant fashion as we do in other channels. Social media is not an all or nothing proposition.

Backlash Protection
I think we (as an industry) protect ourselves by proceeding in as low risk a manner as possible, which tends to be those programs which are nonbranded and one-way in their communications. When we go branded or two-way, we should work within guidelines we clearly understand. At the same time we do this, we will continue our various efforts to petition the agency for further guidance, which I think we can say is having positive effect.

Future Guidelines
I think what we have seen thus far suggests that over time FDA will continue to take a deliberate approach in issuing select guidelines related to specific areas of social media. As to timing, that is anyone’s guess and of course we hope it will be fast.

Kurt Mueller

Kurt Mueller Chief Digital & Science Officer
Roska Healthcare Advertising

kmueller@roskahealthcare.com, Twitter: @roskadigital

The reason that healthcare is so alive in the social media space is simple—people want to connect, interact and share information about their health. They want to know that they’re not alone, and to learn how others in their situation are feeling and coping. And yes, sometimes they talk about treatment possibilities that include using medications beyond their approved use. This is the part that concerns the FDA and sends med/legal teams heading for the hills when their brand team mentions social media or “open fields.” But, it doesn’t have to.

The FDA took a first step by releasing the recent guidelines focusing on the issue of requests for off-label products, in which the agency made three bold statements:
1) Pharma is capable of responding to off-label requests on social sites in a truthful, non-misleading and accurate manner.
2) It can be in the best interest of public health for the manufacturer to respond via social media to such requests. (After all, who better to answer these questions than the companies that manufacture the products?)
3) It does not intend to use a firm’s response as evidence of intent to promote off-label use (reading between the lines…no warning letter).

Patients and caregivers actually want pharma sitting at the table and part of the conversation. Follow the directions below and you can have a seat at the table without fear of a warning letter:
• Have your medical team respond, not your marketing team.
• Keep your answer short and focused only on the specific request (pull from your PI if you have to).
• Be truthful, accurate and balanced.
• Provide information that directs people to the right information and right resource. Give them an appropriate phone number or email.
• Maintain and file your responses. Not only will you be protected, but you’ll also educate the FDA along the way.

The FDA’s recent guidance represents a huge vote of confidence (so let’s not screw it up). Remember, if one patient asked the question many more have the exact same question. Post a response. It will benefit all.

For a “cheat sheet” that demystifies the guidance document, go here: http://bit.ly/w5kczm.

Jim Dayton

Jim Dayton Senior Director, Emerging Media
Intouch Solutions

jim.dayton@intouchsol.com, Twitter: @JimDayton

The social media ball is definitely in the industry’s court. And no matter how many times we, as marketers, volley back to the FDA saying, “We need guidance,” the ball will always be swiftly put back in our court. If we learned anything from the draft guidance that the FDA released in December, it is that the agency is not going to be swayed from its stance that it is about the message not the medium. They have repeatedly stated that the industry must provide truthful, balanced, accurate and non-misleading information regardless of the platform.

It is up to the people in charge of social media at each company, preferably a mix of PR, marketing, regulatory, medical, legal and agency partners, to decide exactly how they will provide information within the limitations of social media and as prescribed by the FDA. As an industry, pharma must decide how it can use these emerging technologies effectively. Some of the social tools will go unused by this industry until social platforms like Facebook, Twitter, YouTube and others take a vested interest in pharma’s specific needs.

The best things for the pharma industry to do now are support and participate in initiatives like the Digital Health Coalition, taking a proactive approach to self-regulation. Companies can also look internally at resource allocation, risk aversion, internal processes and company mindset to decide if they can support social media as part of their marketing communications, because social media isn’t going away. It is how people communicate in the 21st century. We all know that health is one topic everyone talks about, with or without FDA guidance.

Michael Pruskowski

Michael Pruskowski Vice President of Strategy Digital
DraftFCB Healthcare

michael.pruskowski@draftfcb.com

Waiting for the FDA to release overarching digital/social channel guidelines is an exercise in waiting for Godot. The release of these overarching guidelines will never happen. Any light the FDA sheds on the issue will most likely be on a narrow topic, leaving us with more questions than answers.

A case in point is the December FDA communication, “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.” Many are interpreting this as the social media guidance we have been waiting for. Although it is not that significant on the surface, if you look past the normal legalese, a few points surface.

First, the FDA recognizes that the Internet has revolutionized communication and information sharing, thus enabling consumers to become more proactive about their health. Also, it recognizes that manufacturers and marketers are more than capable of responding accurately to requests for information about their own products.

Second, it would be a waste of time and tax-payer dollars for the FDA to attempt to write and revise overarching guidelines for marketing in the ever-changing landscape of technology.

Third, by not providing an overarching response on social media, the FDA has essentially said, “We have provided you with all the guidance you will ever need.” This point should excite marketers, because it has left the door open to embrace social media within the boundaries already provided. Now it is up to marketers and manufacturers to show the FDA, patients, professionals and the healthcare ecosystem how responsible pharma-sponsored two-way communications can lead to healthier outcomes.

Just as the characters wait another day for Godot to arrive before the curtain falls, so too must we ask ourselves, “Do we wait another day?” It is clear from the latest guidance that our Godot has arrived and stated, “You have your mission and everything you need to accomplish it. Now go out and do it.”

Keeley L. Guillerme

Keeley L. Guillerme Account Director
Communications Media, Inc.

kguillerme@cmimedia.com

No one wants to move forward without FDA approval— their guidelines are there for good reason. But we also can’t sit idly by when patients and physicians are actively seeking interaction with pharma on social media and coming up short. The fact is, people are using social media to get health information, and because pharma is limited to fully engage, there is incorrect and often dangerous information on Facebook, Twitter and the like. A typical patient visiting Facebook does not know pharma’s hands are tied to respond to their posts, and perceives it as that company’s unwillingness to help or engage with them.

Childhood vaccines present a good example of information running amok and ultimately affecting public health. People are opting to not vaccinate their children out of a misunderstanding that it could lead to the development of autism. As a result, old diseases that were once eradicated in the United States, like measles, are now making a comeback in record numbers. Much of the misinformation is shared via social media, and could be squashed if pharma had more freedom to interact there.

Lack of social media guidelines for pharma has led to companies implementing their own models for bringing accurate information to patients. Each step forward, however, seems to result in a step back, as many choose to pull back on efforts whenever there is a change in the landscape; for example, when Facebook changed rules around comments to group pages.

In addition to feedback from thought leaders within the industry during the 2009 hearings, as well as the opportunities to comment immediately following, the FDA has more recently released draft guidance for industry review that touches heavily on social media (in December 2011). This is a step in the right direction, as it’s clear the FDA has its ears open to the industry. In addition, on Feb. 6, 2012, the Digital Health Coalition released an excellent seven-point list of guiding principles that clearly and cohesively guide the industry if they are adopted (http://bit.ly/zBaNrY). Our hope is that the FDA will take the industry’s comments to heart and officially issue these guidelines.

Tom Chernaik

Tom Chernaik CEO
CMP.LY

tom@cmp.ly

With recent “Guidance for Industry” in a draft titled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,” it seems that the FDA is aware of developments in social media and beginning to incorporate it into guidance, but that defined guidelines are not going to be forthcoming. I believe that compliance with existing guidelines can be achieved, and (as another commenter observed) waiting for the moment of perfect clarity is like waiting for Godot.

The Dose of Digital wiki lists inspiring examples of pharma digital and social media efforts. Let it be a reminder that you are not alone. There is a growing and active community of social media advocates in the pharma and medical device industries as well as conferences, meet-ups and tweet-ups that focus on these issues. While there is (to a degree) safety in numbers, the 14 warning letters issued on April 2, 2009 should be a reminder that just following the crowd does not bring you into compliance.

In lieu of clear guidance, and with the advice of your counsel, I would suggest that you:
1) Watch for new developments in the space (platforms, technologies, programs)
2) Listen to thought-leaders—Read blogs, articles and discussions
3) Join the conversation—Attend conferences and webinars, ask questions, comment (where possible)
4) Establish policies and educate your teams with regard to social media risks and opportunities
5) Work with your legal and compliance teams to ensure that everyone understands goals, objectives and responsibilities as well as the efforts of other companies in the space.

If the FDA has made anything clear, it is that the same rules apply to marketing communications regardless of the channel that they are delivered through. Furthermore, they have made it clear that there is no “one-click” rule to rely on. While there are inherent challenges to some of the platforms (space constraints, content syndication, two-way commenting), these challenges are by no means insurmountable and the opportunities ahead are both significant and meaningful. Using your existing compliance frameworks, think about how your communications work in traditional formats and work on adapting that process to your social and digital communications.

Pat Connelly

Pat Connelly Associate Director, Digital Strategy and Communications
Millennium: The Takeda Oncology Company

Twitter: @POConnelly

The pace of change and expansion of social channels might seem to create a chaotic and unpredictable environment for pharma, but there are two forces that tend to maintain order:
1) People are still people: The different channels do affect how people communicate, the telephone is definitely different than an email, but what they say and why they say it has not really changed. Everything you know about how your customers think and make decisions is still fundamentally true.
2) The guiding principles of the FDA are channel-agnostic: “New tools, old rules” is the order of the day when interpreting FDA reaction to an initiative. There will always be uncertainty around new channels, and the desire to explore these channels, but it is critical we always follow the core principles of the FDA.

I believe as pharma, we have the first move. We all know that social media is being used extensively as patients and caregivers reach out to others in their networks to discover information and lend emotional support. It is pretty safe to say that most pharma companies have considered entering the social media conversation at one point or another. Where do you start? We must first understand if participating in social media makes sense in the overall strategy we are looking to implement. Social media itself is just a tactic that supports your strategy…and not a strategy in itself.

Surveying the landscape and understanding what conversations are going on around and what conversations are going on about us is the first place to start. After you see what conversation is going on, it will most likely be clear if you should even “take that first step” and what that first step should be. Since there are no social media specific guidelines in place it is going to take time to gain alignment at your organization. You will have to establish internal and external guidelines, develop clear goals, educate your reviewers and make sure that everyone’s expectations of results are aligned. It may seem difficult, but we know the rules already we just need to learn the channels.

Brad Einarsen

Brad Einarsen, MBA Director of Digital Insight
Klick Health

beinarsen@klick.com,
Twitter: @klickhealth

The FDA seems unwilling to put ink to paper and map out what is acceptable when it comes to social media. It’s hard to blame them; there’s not a lot of upside from their perspective. They already have the pharma companies scared of their own shadows; why show them what is acceptable?

So, don’t look to the FDA to create a crisp set of rules. Instead, look for social media to be mentioned as a channel when discussing other topics. In the recent guidance on handling off-label questions a substantial amount of space was devoted to “emerging electronic media,” aka social media. This guidance provided a recognition that industry’s current best practices are acceptable, and even that some interaction and response is allowed. Industry can expect future FDA guidance documents to follow the same format, with social media being discussed in the context of a specific regulatory topic.

Insight on social media usage also comes in the form of official letters. For example, take the Tasigna letter issued in 2010 to Novartis. It clarified that shared “meta data” could not violate the advertising rules—in this case by mentioning indication but not risk. Its most interesting insight was the fact that sharing was giving tacit approval as long as the branded site does not load the user’s share with violative material.

Marketers still need to be careful not to delude themselves into thinking that a borderline activity is acceptable just because everyone does it. The 14 letters sent out in the spring of 2009 about the lack of ISI in search engine ads made it clear that the FDA did not acknowledge the industry’s “one-click rule.” A herd mentality had set in, and marketers who knew better did it because everyone else seemed to be getting away with it.

If industry adheres to the spirit of the regulations with social media it can steer clear of another similar action. In this way pharma brands can enter the new era where customers are respected partners, and industry support helps them succeed in their treatments and improve their lives.

Peter Pitts

Peter Pitts President and co-founder
Center for Medicine in the Public Interest

ppitts@cmpi.org

By now it should be clear to regulated healthcare communicators that delaying robust entry into the world of social media due to lack of FDA guidance is an empty excuse. The recently released draft guidance offers sound counsel but not much in the area of direct guidance.

As more and more people turn to social media as their first and primary portal for healthcare information, absence from the playing field isn’t only a bad business decision—it’s irresponsible.

A regulated healthcare industry must participate in social media, not because of its potency as a marketing vehicle, but because it’s the right thing to do. That being said, here are six principles that must serve as the basic substrate of regulated social media participation.
1) Marketers should engage in social media to help improve the lives of patients and advance the public health of our nation. They should believe in using social media to discover adverse drug experiences, which will then be addressed off-line.
2) They should thoughtfully engage in social media while remaining in compliance with both the letter and the spirit of FDA regulations.
3) All social media messages and partnerships must be accurate, appropriate, and transparent.
4) Healthcare marketers should believe social media presents multiple opportunities to learn more about how our products impact the lives of patients and that social media engagement allows us to correct errors and misperceptions about our company and our products.
5) Marketers should strive to interact in a timely manner, appropriate to the general expectations of social media. They should also believe that social media programs must be regularly monitored and measured in real-time to gauge effectiveness.
6) Marketers should also believe the path to engagement is through useful and thoughtful content and commentary, but they are not responsible for user-generated content that resides on sites we do not control.

One principle that runs throughout all of these is transparency—real, honest transparency—not the usual translucency that “in compliance” often brings.

It’s time for action. As Friedrich Engels said, “An ounce of action is worth a ton of theory.”

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