Compliance in the Pharmaceutical Industry:
A Marketer’s Perspective

Originally published on PharmExec.com

Now more than ever it is important for pharmaceutical companies to put compliance as their number one priority. In this Q&A, Kristina Dolan, Director of Marketing at Ecos, interviews experienced multi-channel marketing manager, Adi Borovick. Borovick dives into the implications of compliance for marketers in a world with new technologies being created every day.

KD: How have you seen the importance of understanding regulations within your industry grow?

AB: Regulations in the pharma and device industries are continually changing. If you are familiar with the PhRMA Code on Interactions with Healthcare Professionals, you know the majority of regulations were developed to protect the patient. While it is up to your organization to develop policies designed to ensure we are putting patients first, it’s up to you as a marketer to understand the code and how that impacts marketing your products.

In addition to the changing regulations, the platforms and channels consumers are using to engage with their healthcare are also changing. Because of this, it requires a marketer to continually think about new, creative ways to drive engagement and awareness for their brands. For example, many companies use social media to drive brand engagement, however, with a pharmaceutical product, this is more difficult due to requirements when making a claim toward a product. Because of this, many marketers use non-branded, disease awareness campaigns to drive social engagement.

KD: What have you learned about developing best in class marketing materials in this highly regulated industry? 

AB: While the scrutiny of the healthcare industry is high, the expectations of HCPs and consumers alike require core marketing principles, including campaign development. Solid campaign development is first based on brand strategy and having a strong understanding of the target audience. When these have been established, you can then begin thinking about tactics to support your strategy.

I think any person in the pharma industry would quickly cite the regulations as something that sets it apart in the way product messaging is developed. What you might not realize is every tactic created is submitted to the Office of Prescription Drug Promotion for review, however not every piece is reviewed. It is up to the organization to self-regulate, ensuring the material is on-label.

Collaboration is key for any tactic in a marketing initiative to ensure it is presented in a fair and balanced way. Developing relationships with a cross-functional team is critically important. Standard members are your market research, finance, and legal partners. Important members to include are also your medical and regulatory teams. Best practices are inclusion of these partners in brainstorming, strategy sessions and concept reviews. Early buy-in and frequent communication are key fundamental practices of my colleagues and I.

More specifically, when it comes to fleshing out your campaign, your regulatory partner may have parameters to consider when building marketing materials, and the smallest details are sometimes the most important. The font size is a detail I’ve consistently discussed when related to promotional materials. For example, the FDA regulates the Important Safety Information on a piece must take up a certain portion of the page, and the positioning in relation to the claims is critical. Understanding these details in advance can lead to a more efficient development and review process.

But your work is not complete when you finish the tactic. Implementing controls and processes to regulate how your sales team and customers are using marketing materials is just as important as the development of the piece. A control many healthcare companies are moving toward is purchasing a technology platform that can automate these processes. These systems control access as well as prohibit changes from being made to approved materials.

KD: How are innovative pharma companies leveraging new technologies to up their compliance games?

AB: There are advantages to using technology and software programs to ensure the controls and processes established are being followed. For instance, a Customer Relationship Management (CRM) solution provides an organization greater visibility to their customers, update previous sales targets, customize marketing messages and provides a portal for marketing materials. The right CRM platform allows a sales team to automate processes which were once manual, such as sample management.

While peer-to-peer lectures, lunch and learns, and other presentations are still seen as an impactful way to provide information to HCPs and patients, strict regulations can make executing them a difficult process. Presentations are designed like marketing materials, presenting information in a fair and balanced manner. Your technology must ensure the presentations and digital materials will be used as they were intended, without changes being made.

It is important to have a nimble marketing organization, reacting quickly to update presentations as needed. For example, the FDA may tell the organization a certain claim can no longer be used, or on a more positive note, new data allows a new claim to be introduced. Because of this, an important feature of your platform should support the need to ensure any old presentations can no longer be used and archived for your records.

KD: How important is it for pharma marketing teams to ‘keep an eye’ on the messaging/content utilized by sales and others within the company?

AB: In my years in marketing, I’ve learned many valuable lessons when it comes to the use of materials with the sales force. When we started using digital technologies as a platform for marketing materials, we were eager to embrace these digital technologies and completely forgo the use of printed materials. We quickly learned a few things. Your sales team may not be as eager to embrace the new digital visuals as their only support for selling the product. Additionally, not all HCPs and customers are ready to embrace these digital assets, wanting something more tactile they can review after a rep has left their office. This is going to vary company to company, and within the specialty of the physician. As technology evolves, it is critical to develop not only the right materials, but also consider the proportionate amount of digital vs. printed tactics to support the sales team. A great format of printed material is a one-page flashcard, with easily digestible messages and supporting facts.

When you think about keeping ‘an eye on’ the messaging and materials, keep checking in once a piece is distributed to the field. Developing a small team of experts within the sales organization is an easy way to understand how your materials are resonating with your core audience.

Additionally, the compliance team will often conduct field rides with the reps to evaluate the use of policies set for the sales team. Marketing should keep the sales team updated once materials have been released to set the organization up for success. Communications to the field should let them know about new tactics as well as tactics that are no longer approved for use and how those materials should be discarded.

KD: How are companies using innovation and technology to connect with consumers?

AB: Technology is changing the way patients access healthcare professional advice. Telemedicine offers a variety of options to patients providing 24/7 access to HCPs using apps, web and video services. This is broadening healthcare options to those who may not have easy access to an HCP.

In turn, pharma companies are providing tools for patients and caregivers via apps and websites. Novartis launched the ViaOpta Applications, a series of apps intended to foster independence for the visually impaired. These apps are offered in multiple languages and connects with wearable devices. Among the apps, ViaOpta Nav is designed for those with low vision, providing voice guided and turn by turn directions. You can find points of interest near you and save your favorite locations. ViaOpta Daily is also a voice-guided system, helping to facilitate recognition of items such as money, colors, objects and people. You can listen to the weather or access your phone’s contact list. These innovative technologies are providing tangible solutions for visually impaired patients.

Also within the series of apps is ViaOpta Simulator, designed to simulate symptoms from vision loss including cataract, glaucoma, wet age-related macular degeneration, dry age-related macular degeneration and other eye care diseases. This provides caregivers and HCPs an outlet to understand the patient’s field of vision and what they may be experiencing.

Excedrin, has introduced The Migraine Experience, using an augmented reality platform that will replicate common migraine symptoms using a downloadable app and a virtual reality device. Non-sufferers can visualize some of the common migraine symptoms such as sensitivity to light, thumping headaches, disorientation, floating spots and auras, providing them a deeper understand about the ailment. Personal stories on the website continue the experience, showing the true impact of a migraine and more information about Excedrin as a treatment option.

At the end of the day, we as marketers have an important job to do. We want to arm our sales force with the tools they need to effectively communicate to HCPs and we want to inform and educate consumers about our products. Maintaining a solid foundation of relationships and implementing the right technology platforms can ensure we are meeting compliance standards.