Regulatory and Innovation: It’s Possible

Can ad/promo regulatory professionals be innovative thinkers? Some have argued that these two terms are incongruous and that asking a regulator to bring innovation to promotional marketing is paradoxical.

While the regulatory function is charged with risk management, this does not prevent these professionals from thinking outside of the proverbial box to help their marketing colleagues achieve business objectives.

Indeed, regulatory professionals who ask questions, put their ego aside, are solution-oriented, and don’t let past experiences and beliefs taint current or future collaborations can propel their companies’ brands to new heights. How?

Be Open to the Possibilities

“Your past experience with regulatory professionals will color your present perspective on their creative value,” explains Stacy Joseph-Reese, Director of Regulatory Promotional Review for Teva Pharmaceuticals. “Marketers who have seen the benefits of a collaborative partnership are more likely to be open to innovative ideas from members of the promotional review team. Marketers that expect to have tension will be more likely to experience tense relationships.”

Maria Finlay, Associate Director of Oncology Marketing at Teva concurs and adds that, “It’s important to always assume good intent when working with new functional team members and respect the experience that regulatory colleagues bring to the table.”

“We are Regulatory’s business partner and this means we need to make the time to connect and build trust both inside and outside of the process,” she adds. “With this united approach, the team can evaluate new concepts and brainstorm innovative approaches in the face of complex business challenges.”

Do Your Homework

Even if regulatory professionals have collaborative personalities, experience does matter.

“Less experienced regulators typically take a more conservative approach. In my experience, regulatory professionals who are more knowledgeable and seasoned are more resourceful. These more experienced regulators tend to present creative solutions that meet marketing objectives,” asserts Finlay.

Joseph-Reese strongly believes that regulatory professionals must come to the table having done their research on the issues brought forward by commercial. “When regulatory professionals are fully knowledgeable about the key topics, they can effectively navigate the barriers and help formulate innovative solutions.”

The take-away: Supplement what you don’t know by researching the topic. Background research can include analysis of FDA guidance documents, medical reviewer comments, violation letters and feedback from the Office of Prescription Drug Promotion (OPDP).

Explain Why

Finlay appreciates when regulatory professionals provide the rationale behind decisions because this information can open the door for new solutions. “When marketers understand the ‘why’ behind regulatory boundaries, we can provide suggestions or recommendations for consideration to address the concerns. Then together Regulatory and Marketing can determine how to achieve these same goals with meaningful and compliant tactics which align with the strategy.”

More often than not, explanations are needed for certain “subjective” words that can’t simply stand on their own—for example, off-label, outside the regulations, violative. Innovative regulators provide context and detailed examples so commercial understands the rationale behind questions and concerns.

Teach with the Right Tone

Regulatory professionals who are sincerely open to innovative ideas must interact with Marketing using a neutral tone, says Finlay. For example, “What are you trying to achieve? Can you help me understand the purpose of these tactics? What is your definition of success? What will happen if we don’t do it this way? In the same vein, marketers must take the time to explain their needs and goals without being defensive or patronizing.”

“Teaching one another how to create an innovative environment is part of the solution,” claims Finlay.

Be Solution Oriented

A solution-focused approach helps commercial teams meet business objectives while saving time and resources.

“When launching a new product, getting the promotional materials into the market is a key priority. Teams must consider the need for seeking FDA advisory comments on core materials, the implications of potential feedback and impact on timelines,” says Joseph-Reese.   Researching FDA enforcement letters, previous advisory feedback and guidance documents can help drive strategy or provide clear and supportable regulatory direction when this path is not taken. Specific examples and recommendations can help the team collaborate on thoughtful solutions. For example, I have proposed revised content for a draft sales aid by creating a visual mock-up to help the team understand the proposed regulatory solutions and quickly reach final agreement.”

Iris Gibbs, Associate Director of Regulatory – Advertising and Promotions at Regeneron Pharmaceuticals, Inc. adds, “Careful monitoring of first amendment challenges and FDA warning and untitled letters allows our team to do a better job of gauging the risk/benefit profile of potential commercial claims. Companies have to assess their internal risk tolerance and then Regulatory partners can help craft innovative and creative messaging to meet that level of tolerance.”

Plant the Seed Early

Marketing and Regulatory can interact even earlier to engage in informational discussions about strategies and tactics. These conversations can set expectations and frame up the innovative idea before a formal review takes place.

Joseph-Reese explains that “Too often marketers have spent time and money on an idea before the concept review. With high level discussions, you can begin development with your eyes open because expectations have been set based on a real understanding. This prevents too much back and forth because you can collaboratively work out issues before money is invested.”

Collaborate on Digital Transformation

Mobile apps that support safe use of medication and increase adherence can help patients achieve treatment goals in coordination with physicians. Real-world data also provides information on safe use of medicine or reasons for premature discontinuation. HIPAA-compliant platforms also provide customer insights through anonymized longitudinal data and on patient/HCP engagement with the brand or company.

Yet mobile patient apps supporting pharma brands have been difficult to review and approve, often due to issues of balance and disclosure, data privacy, 2253 OPDP submission, and concerns on apps becoming “medical devices.”

“Proper provision and accommodation for brand fair balance and disclosure is fundamental to achieving mobile app OPDP compliance, regardless of whether the app supports HCPs or patients,” comments Dr. Peter Pitts, Chief Regulatory Officer at Adherent Health and a former FDA Associate Commissioner.

The Mobile Health Library from Adherent Health is HIPAA-compliant and allows for custom balance and disclosure to ensure brand compliance with OPDP requirements. This makes it easier for Marketing and the review team to be innovative and compliant.

Embrace Cognitive Flexibility

Cognitive flexibility has been broadly described as the ability to adjust one’s thinking from old to new situations and to overcome habitual thinking in order to adapt to new situations. Moreover, professionals that exhibit cognitive flexibility can simultaneously consider two aspects of an idea or situation at one point in time.

Cognitive flexibility techniques help regulatory, legal, compliance and medical functions think more creatively and strategically when working with Marketing. We can teach how to shift a previous belief in response to a change in rules. For example, if the belief is that, “It’s not possible to compliantly execute a digital tactic or campaign because FDA guidances are still gray,” we can help adjust the thinking to examine all the possibilities for how a digital tactic might be executed in compliance.

Stay Focused on the End Goal

According to Michael Parisi, Managing Partner of Ogilvy CommonHealth Worldwide, “We need to remember that Regulatory’s job is to keep Marketing out of hot water by operating within the current regulatory limits. With this in mind, there are four pillars to develop award-winning, mind-blowing, creative and compliant work: Trust, communication, mutual goals and collaboration.”

So it’s time to start adjusting our thinking: Professionals in regulatory roles can be, and currently are, innovative.

  • 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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