How to ‘digitally and socially’ win over your legal / regulatory team

Colleen Broughton, William Reese and Jim Walker

Cadient Group

This afternoon’s article provides some top tips in order to maintain a happy working relationship with your legal and regulatory teams, particularly when it comes to implementing social media communities.

Social media in the pharmaceutical industry continues to generate a great deal of interest, discussion and debate – creating unintentional, adversarial relationships for brand marketers. For brands that decide to move forward with a social media concept, gaining legal / regulatory approval can be a significant hurdle. In this article, we will examine three ways that brand teams can better collaborate with their regulatory counterparts in the review and approval process, and succeed in bringing their social media communications to life.

1. Packaging your social media concept for legal / regulatory success

When approaching your legal / regulatory team with a social media concept, you will need to help them understand the framework of the campaign you are developing, and the business rationale behind it. Simply announcing “We’re creating a Facebook community because our biggest competitor just launched a Fan Page,” is not going to advance your cause! So, take time to anticipate any potential hurdles and roadblocks before approaching your team. From a basic communications standpoint, make sure that your concept and campaign is easy to understand and visualize. The user experience should be clear, the scope and range of the campaign well-defined, and the success metrics defined and measurable.


“…take time to anticipate any potential hurdles and roadblocks before approaching your team.”


If you have these communications basics taken care of, then your next focus needs to be on all potential regulatory concerns. Fortunately, the questions that legal / regulatory teams focus on for evaluating social media campaigns are straight forward. Here are 16 of the top questions you are likely to encounter:

a. Who is the audience for this campaign?

b. If ‘commenting’ is going to be allowed, how and who will monitor those conversations and content shared?

c. Will a social media listening and monitoring platform be used?

d. How often will you be monitoring and providing an analysis?

e. When monitoring what will you do with the data collected?

f. How will the data collected be used with the regulatory / legal team to prevent and report adverse events?

g. What is the likelihood that adverse events be shared?

h. Are you aware of the four pieces of criteria for adverse event reporting in social media?

i. Can you flag the adverse event data when such criteria is identified? How quickly can you alert the legal / regulatory team?

j. How many adverse events would you anticipate for this particular campaign?

k. Can ‘comments’ be removed if we don’t agree with what a user posted?

l. What if your social content is re-posted in another location, and out of context?

m. Will there be fair balance and how do you plan to tackle this?

n. How much content will need to be approved / posted?

o. Will an editorial calendar be developed so all approved communications are approved in advance?

p. Have other pharma companies done similar campaigns? Which ones? How are they working?

While you may not have specific answers to all of these questions, if you come to the review meeting ready to discuss these topics (and with no surprises), the credibility of your concept will be greatly enhanced. Also, be sure to make your proposal, concept and campaign presentation as specific as possible. While most legal / regulatory teams now have gained at least some familiarity with social media communications, it is rare for them to be social media experts. In fact, one of your major roles will involve educating your team about the specific details of social media and the marketing / communications / public relations opportunities it presents.

2. Providing the right education to your legal / regulatory team

All too often marketing / communications pros look for buy-in too late in the process, and leave legal review meetings disappointed or delayed. Even before you arrive at a legal review meeting you can improve your experience, and business efficiency, by making sure your legal / regulatory team is aware of what you are up to, both from a concept and a process standpoint. Reviewers can be reasonable (Yes, it’s true!), but how do you make them comfortable? Try these five tips for keeping your legal / regulatory team in-the-know:

Ask for consultation: Legal / regulatory’s job is to mitigate risk. As a marketer, your job is to convince them you have paid attention to risk. A simple way to show you respect their role—and time—is to ask for a short concept meeting. Find out what concerns, objections, etc., they have ahead of time. Involving them from the beginning means you can focus your work on addressing concerns, instead of worrying about their approval. Plus, when you come back for approval, they won’t be surprised: reviewers hate surprises.

Timing: Legal / regulatory teams are often short-staffed and over-scheduled. Educate the review team about your timing and make sure they are available to meet your deadlines. Provide full details about your project, set meetings ahead of time, make sure they are on-site and available, and communicate any changes / delays to help your project stay on track. Develop a project timeline and keep it updated to keep everyone on track every step of the way.

Note preferences: Take the time to ask / learn about your review team’s style. Do they like phone calls or in-person conversations? Do they prefer a website link to a demo site along with paper copies? Do they like changes red-boxed for faster review? Can you point out how many pages are just changes versus documentation? The more pleasant you make their review experience, the faster they will evaluate and approve your campaign. Ever add a fun sticky note in the middle thanking them? They might even look forward to getting your submissions!


“While most legal / regulatory teams now have gained at least some familiarity with social media communications, it is rare for them to be social media experts.”


Provide training: One way to educate marketing partners, not just reviewers, is to offer ongoing internal training. Social media education on a regular basis, a “Pinterest” bulletin board near the coffee bar, a one hour lunch and learn, or guest speaker series. If you don’t have the bandwidth, ask an agency partner to provide training, examples or content. Be sure to connect trends to tasks that provide business value (such as competitive analysis and audit of competitor’s social media presence). When social media information is consistent, versus a one-time project, you promote credibility and expertise.

Lead by example: You know they’ll ask, so collect and maintain great examples of similar campaigns (in and outside the pharma industry). Before and during the review, provide relevant examples to alleviate concerns – note how they prefer to see the examples (online, print-outs), and be specific about how the sample relates to your campaign. However, be careful about assuming your review team will approve based on what others are doing. Show them how YOU will be protecting the company / product while increasing awareness and providing value to customers.

3. Collaboration between marketing and legal / regulatory

The third key component of having a positive legal / regulatory experience is to embrace social and digital communications tools as part of the collaborative process. The best programs were born from positive consultative relationships between marketing / communications pros and their review teams.

Five ways to introduce collaboration into a legal / regulatory relationship:

Embrace rapid prototyping: For more complex ideas develop small interactive prototypes to give the review team an idea of how a new idea is going to work and how a user will move through the program. Often times seeing how something works in context can make a big difference in the risk it presents or mitigates.

Post online concept reviews: Post prototypes or early concept designs online and capture specific feedback on site elements to identify key areas of concern or risk before formal submissions. Constructive feedback earlier in the process that can be completed with flexibility on the part of the reviewer can help avoid major red flags.

Socialize a running hot list: A high degree of review team frustration can be avoided by creating a running list of key decisions and do’s / don’ts that can be shared with all the teams involved. This avoids repeating the same mistakes across programs and channels. The time and frustration saved can be used to focus on the newer or more challenging program components.


“…embrace social and digital communications tools as part of the collaborative process.”


Develop a marketing example wiki: Develop a wiki of industry examples across common program elements like mobile, social, ISI, AE monitoring, story sharing, etc., that can be leveraged across brands, agency partners, and review teams. This becomes a handy common reference when discussing industry standards and best practices.

Standardize a program brief: Many times the process goes off track because there is not a shared understanding of how the program affects the business, impacts the customer, and what the marketer is trying to accomplish with the program. By creating a short brief and embracing a status update style (140 characters or less) that answers each of these components can help to ground review teams when discussing new social or digital concepts. This brief is helpful to provide common ground when how to solve a particular challenge.

Not all of these tools will fit every organization. Company culture and the existing review process are key drivers of the comfort level to increase collaboration. Take on some of the questions posed in this article – and use the answers to help guide or inform your company’s specific approach to social media practices and policies. Coming together as a team, especially as it relates to the issue of legal and regulatory risk, can be tough enough. Companies who are successfully pushing the boundaries of social media in healthcare marketing have created a high level of and trust and collaboration between their marketing and legal / regulatory teams. They share information, communicate regularly and understand the goals, risks and responsibilities of their counterparts.


About the authors:

William Reese – Chief Innovation Officer

As the Chief Innovation Officer at Cadient Group, William leads the innovation team at Cadient Group to identify strategic opportunities within the healthcare space to drive deeper relationships with professionals, consumers, and payers. To this leadership role, William brings more than 10 years of healthcare industry experience, providing marketing strategy, program management, information architecture, and technical consulting for major pharmaceutical clients, including Pfizer, AstraZeneca, and Johnson &amp, Johnson. His industry expertise has led him to develop award-winning campaigns for numerous category-leading brands, and he has extensive experience in product launch and professional marketing. Prior to joining Cadient Group in 2002, William developed interactive solutions for Lippincott Williams &amp, Wilkins’ electronic medical publishing group. There, he managed both the project development and quality assurance of interactive CME programs, online journals, and hospital education intranets.

Colleen Broughton, Strategic Consultant

Prior to connecting with Cadient Group in 2007, Colleen was creating social media policy and moderating a Type 1 diabetes community. In her 15+ years of consumer and professional marketing with the Johnson &amp, Johnson Diabetes Franchise, she launched the first diabetes medical device Web site in 1996, and produced award-winning digital content and user-friendly Web sites. She’s directed a wide-range of marketing efforts from eCards and recipes to BB King song contests and direct-response television, from HealthVault components to negotiating social media applications in a regulated industry, and from creating diabetes education in 19 languages to pioneering the J&amp,J Diabetes Institute.

Jim Walker – Director, Emerging Trends

Jim provides strategic marketing and communications insights for a wide range of clients, focusing on Healthcare 2.0 solutions. He is particularly interested in helping brand teams take advantage of social networks, mobile marketing, and video-based campaigns. He has worked on a wide range of prescription drugs targeting both healthcare professionals and consumers. Prior to joining Cadient Group, Jim has had extensive experience in e-Marketing as the founder of an online company, as a consultant, and as a trainer. Jim has held e-Promotions positions at major pharmaceutical companies, including AstraZeneca and GlaxoSmithKline. At AstraZeneca, Jim was a Brand Promotions Manager, developing healthcare professional programs in support of Atacand. Prior to that, Jim was an early employee at Cadient Group before leaving to become the founder and president of Mind Palace, an online company promoting a unique software package.

About Cadient Group:

Cadient Group is a leading digital healthcare marketing agency – serving a diverse range of industry markets and stakeholders, including pharmaceuticals, biotechnology, medical devices, hospital/healthcare systems, institutions and associations.

Twitter – @CadientGroup


How do you maintain your relationship with legal / regulatory?