Compliance is a Balancing Act—And Completely Achievable

Due to the central role that promotional regulatory compliance plays in the success of the drug and device industries, I recently attended the DIA’s annual Marketing Pharmaceuticals Meeting. As this meeting continues to be extremely influential in these industries, I pulled five topics from the meeting and included the insights of industry veterans to illustrate just how highly relevant compliance is to all stakeholders involved in promotional activities.

1. FDA’s Concern: Repeated Violations

Omission and minimization of risk information, unsubstantiated superiority claims and overstatement of efficacy are still the most common violations, according to FDA Director, Tom Abrams, who shared his perspective on Office of Prescription Drug Promotion (OPDP) Warning and Untitled Letters. The Center for Biologics Evaluation and Research (CBER) noted that absence and minimization of risk in promotion as common violations, while the Center for Veterinary Medicine (CVM) cited enforcement actions over lack of fair balance and unsubstantiated claims.

2. FDA Issues Fewer Warning Letters

Fewer Warning and Untitled letters have been issued this year than in past years—and it’s no accident. Why? According to the consensus of an expert DIA panel moderated by AstraZeneca’s Senior Director of Promotional Regulatory Affairs, Glenn Byrd, and representatives from Merck and Eli Lilly, companies are investing in comprehensive processes to optimize regulatory compliance. The panel agreed that industry must be laser focused on promotional review excellence if it wants to manage risk and save time and money—because review process efficiency can ensure consistent content quality. The panel also gave recommendations for maintaining quality, including the need to investigate and eliminate the origin of errors. To help promotional review team members master regulatory compliance requirements the DIA launched a series of educational modules at its meeting—which is timely given the increasing demands on medical, legal and regulatory professionals to remain compliant in today’s complex regulatory environment.

3. Balance Innovation with Compliance

In several breakout workshops, the hottest topic concerned the regulatory complexities around social media and medical applications. The pharma and med device industries, according to an overwhelming consensus, cannot lag behind in uptake of these digital technologies.

“A greater awareness, understanding and appreciation of the ‘what, how, who and why’ of innovative marketing tools can exponentially enhance efficiency within the PRC review and approval process,” explained Lyn Hopkinson, VP, Commercial Regulatory Affairs, Vertex. As an example of compliant, effective use, Jennifer De Camara, Assistant General Counsel, Johnson & Johnson (J&J), described strategies to shift companies away from insecurity and hesitation in social media use to developing internal standards and channels that provide clarity of thought and process about how to appropriately use this new media.

De Camara and her colleague, Philomena McArthur, Senior Director, Regulatory Advertising and Promotion, J&J, noted that they have successfully focused on moving their company beyond asking “whether or not to execute social/digital media” to “this is how we can successfully engage online.”

4. Cross-Functional Collaboration Aids Compliance

Cross-functional team members who master digital regulatory basics fuel more efficient and successful collaboration as new terrain is explored, according to industry experts who spoke at an event held at J&J that focused on accelerating collaboration around digital initiatives.

“Regulatory, legal and compliance executives must feel confident that promotional agency and marketing’s recommendations are conceived with basic regulatory understanding,” said Wayne Pines, a former FDA official and Advisory Board Chair for the Center for Communication Compliance (CCC). Pines noted that content originators—marketers as well as promotional agencies—must understand the regulatory fundamentals to avoid submitting materials containing non-negotiable, non-compliant elements.

“We have found that a collaborative approach among marketing, agencies and regulatory can help teams create multi-tiered review processes that meet the needs of our audiences with accurate, compliant information and timely responses to questions and comments,” said Brad Einarsen, Director of Digital Insights at Klick Health. One way this can be accomplished: Identify and close regulatory knowledge gaps before materials are developed. This will remain important with new disclosure requirements in Europe, more guidances in FDA’s pipeline (unsolicited requests, disease awareness, PE data, links), and hotly debated topics such as scientific exchange.

And industry veterans concurred.  “I’ve been in marketing long enough to know that if you want cleaner digital materials to enter the system, you need to require all stakeholders to understand and apply the regulatory rules to create potentially approvable materials,” stated Stephanie Bova, Head of Takeda’s EUCan Digital Accelerator practice. Bova stressed the importance of “going above and beyond to make sure everyone involved has the proper education and mindset on what’s possible.”

“It is imperative that PR teams understand the regulatory nuances that apply in-market and across the region,” added Rachael Pay, a promotional agency veteran and Managing Director of Weber Shandwick’s Health EMEA practice.  When asked about the compliant use of digital, Shannon Hartley, Managing Partner of Razorfish Health, strongly emphasized,“…regulatory compliance savvy is essential to meet the evolving digital expectations.”

5. Education Reduces Financial Waste

Through staff education and testing, promotional agencies are becoming more proactive in avoiding submission of materials that include non-negotiable, non-compliant elements—which helps the bottom line. In fact, data published in the DIA Global Forum shows companies can save upwards of $2 million in pure financial waste for every 10 brands (

These strategies can result in quantifiable benefits for optimal risk management with marketing impact. David Flynn, VP, Framework Solutions, a company that specializes in professional services for the Ad Promo Review Process, stressed, “The review and approval process must be clearly defined and consistent. Most importantly, the owners of the process must enforce rules and make stakeholders accountable. Only if commitment and collaboration exist across all stakeholders will the process be optimized.”

The opportunity to create a culture that results in competitive and compliant marketing campaigns with high commercial impact is ripe. Best-in-class promotional review processes and web-based screeners now can control the quality of promotional content—along with proven methodologies to increase cross-functional team effectiveness. These support behavioral changes in which regulatory, legal and compliance professionals can help advance business objectives, and commercial/marketing can enjoy a competitive advantage while operating within a compliant culture.

  • Ilyssa Levins

    Ilyssa Levins is President and Founder of Center for Communication Compliance (CCC). Ilyssa helps manufacturers and their promotional agencies save time, money and manage risk, when promoting drugs and devices. She combines her regulatory compliance, marketing communications, and change management expertise to help clients achieve their goals.


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