One of the most important ways regulatory, compliance, and legal professionals can advance the goals of commercial business is through close collaboration with their marketing and communication colleagues. And digital and social media is a good example of where this collaboration can be most effective.

Antiquated regulatory frameworks, lack of transparent guidance and complex enforcement environments make it challenging to institute digital and social media campaigns for prescription products. However, given the high level of patient and caregiver interest in information provided through digital channels, there are important benefits for communicating information regarding prescription products using these media. Moreover, manufacturers are arguably in the best position to provide accurate information about their products.

For these reasons, companies need to find innovative approaches to help brands successfully engage in Internet promotion and social media while meeting regulatory promotional requirements. These include, but are not limited to, providing a fair balance of information despite significant space limitations and ensuring easy access to important product information about potential risks and benefits.

Marketing and communication groups can collaborate with their regulatory and legal colleagues to shift companies from insecurity and hesitation around social media to developing internal standards and channels that provide clarity of thought and process about how to appropriately balance key issues. The six best practices below can help move companies beyond asking “whether or not to execute social/digital media” to “this is how we can successfully engage online.”

1. Align Around Goals and Objectives

Without the true understanding of a company’s end goal, regulatory and legal colleagues cannot provide effective counsel. Therefore, as early in the process as possible, teams developing social media approaches should apprise regulatory and legal partners about the exact goals and measurable objectives for planned digital media. This information will enable them to identify any potential issues, provide suggestions in meeting the regulatory requirements, and outline safeguards to help prevent unintended results (including sunk cost on media that ultimately cannot be implemented).

2. Educate on Digital Fundamentals

Regulatory and legal professionals typically do not have a core competency in digital technology. Teams developing social media approaches should allot sufficient time to help educate non-commercial professionals about digital and social media tools. This will enable regulatory and legal colleagues to suggest viable and effective alternative approaches and solutions to potential issues.
For example, tweeting about a branded product raises very different issues than placing a static advertisement on a social media site. Another example would be the necessity of understanding what content is being communicated upon the click of a share button, when content can be commented upon, and how the content will be displayed and accessed on various devices. Each of these examples has specific regulatory implications and requirements that must be adequately addressed.

3. Establish Analogues for Reference

It is extremely useful to use a “bricks and mortar” (i.e., non-digital) analogy to foster discussions around the compliant use of a particular digital or social media tactic. This helps colleagues think about how they can successfully execute a proposed digital/social media activity while meeting all the regulatory requirements for that communication. Once everyone understands the parameters, it becomes easier to discuss alternative solutions.
One “bricks and mortar” analogy revolves around figuring out how to meet fair balance requirements when using digital applications with space limitations.

Consider a printed, multiple-page visual aid as the analogue. Each page or “spread” of that visual aid that contains efficacy information must also contain a balance of safety information. This is generally achieved by including a summary of safety information on the page or spread with a reference to the page in the visual aid where the additional safety information can be found. Similarly, a digital application that presents a summary of effectiveness information can include balance in the form of a summary of safety and include a link to where the additional safety information can be viewed.

4. Introduce the Content Creation Colleague

The content creation colleague(s) on the team supporting the digital/social media activity must be educated on the key regulatory issues and concerns around digital and social media campaigns as soon as possible. It is also wise to introduce the individuals working on content to the legal and regulatory team members at the start of any initiative. This will increase the likelihood that initial creation of content will meet regulatory and legal parameters, thereby speeding copy review. A clear partnership is especially important when discussing new or never-tried concepts prior to investing significant resources into content creation. This ensures that everyone agrees on the business goals, how they can be executed or achieved and next steps.

5. Create a Digital Toolkit

A digital toolkit outlines business and compliance considerations for digital and social media campaigns and tactics, and ways to approach them. It is a practical way to provide a general roadmap for successfully engaging in digital and social media platforms. As new digital platforms become available in the dynamic technology environment, new toolkit topics can be added or enhanced. This enables businesses to set compliant goals despite the constant evolution in regulatory and technology environments. Examples may include considerations in setting up a YouTube or Facebook site, or Twitter account, among others.

6. Ongoing Communication and Monitoring

Routine interaction between regulatory and legal colleagues and their marketing and communication partners helps identify not only opportunities, but potentially challenging situations. It’s critical to have a well-defined process around social media and digital efforts so that information about changes and new issues can be cascaded clearly within an organization and any appropriate modifications made. Many unintended outcomes can be avoided through careful communication in the first instance since most social and digital media mishaps are a result of not “pressure-testing” the multiple outcomes.

A team of multi-functional experts (including digital marketing, IT, communication, etc.) can provide different and often unexpected points of view. Their feedback can lead to proactive refinements of the communication strategy and a clear consensus on next steps. Likely issues based on the activity and the platform can also be identified in advance and reactions planned accordingly. Monitoring and clear communication pathways not only allow for handling of social/digital media issues, but for refinements in the actual communications strategy.

Teams should also be prepared for the fact that the regulatory environment continues to change rapidly and that scrutiny on areas such as privacy, trademark and copyright infringement is increasing. State and federal agencies are very active players in the social media space and are watching its evolution carefully. Legal and regulatory partners need to have systematic methods to ensure that these developments are identified and analyzed for relevance to ongoing digital and social media efforts. This also ties back to the importance of having a well-defined process around social media and digital efforts that can be quickly refined and shared with all relevant individuals within an organization.

Conclusion

Open lines of communication and streamlined procedures to approve content are a must in the fast-paced social media world. However, that does not mean that compliance must be compromised. Methods and tools can be developed that allow for a good understanding of what information will be communicated in digital and social media venues, what will happen to that information and how the company should react. Those tools and that understanding give companies ample time to refine their digital/social media communications and avoid any disruption in marketing activities. When regulatory, communication, legal, marketing and compliance colleagues partner early and work together, they can develop compelling, effective and compliant digital and social media campaigns.

Disclaimer: The views and opinions expressed in this article are those of the individual authors and should not be attributed to their company(ies), its directors, officers, employees, volunteers, members, affiliates, or any organization with which the author is employed or affiliated.

  • Philomena McArthur

    Senior Director, Regulatory Advertising and Promotion, Pharmaceutical Group Health Care Compliance at Johnson & Johnson International. She is also a Steering Committee member of the DIA.HBA Leadership Project focused on driving business through high value partnerships.

    • Jennifer de Camara

      Assistant General Counsel at Johnson & Johnson. She is also aSteering Committee member of the DIA.HBA Leadership Project focused on driving business through high value partnerships.

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