Can Regulatory Requirements actually Unshackle Promotional Creativity among Marketers?


We’ve all heard this complaint from marketing professionals and their promotional agency partners: “How can we be creative with all these regulations?” So when I came upon a blog post titled “Boosting Creativity through Constraints” written by innovation expert Adam Richardson in his Harvard Business Review, I had to flag it.

Conventional wisdom holds that the best way to boost a team’s creativity is to unshackle them from constraints, Richardson explains in his blog. He goes on to counter this perspective and makes the unique assertion that the best ideas actually come not from thinking outside the box, but from having boundaries – especially those that move the team toward clarity of purpose.

My immediate reaction: That’s really good news for healthcare marketers and promotional agencies responsible for developing compelling and creative ideas that must be in compliance with government requirements. This is also an excellent discussion point for members of the promotional review team if this issue comes up.

So I decided to ask several regulatory experts to weigh in on this paradox of “more restrictions = more creativity,” including professionals who will be speaking at the February 2015 DIA annual conference on Marketing Pharmaceuticals and other industry veterans collaborating with DIA.

“FDA enforcement actions and guidances make it easy to establish the boundaries within which marketing and regulatory teams must work,” states Tracy Rockney, Vice President, Regulatory Affairs, AbbVie. “Marketers who take the time to read them will understand what OPDP (Office of Prescription Drug Promotion) is really trying to communicate.”

Eisai’s Lynette Hopkinson, Senior Director, Commercial Regulatory Affairs, concurs.  “The publication of five draft Guidance Documents in 2014, particularly the three on social media, will help pave the path for increased product promotion activities in 2015. More insight into how OPDP views the role of manufacturers on the internet should enable promotional review committees to feel more comfortable approving impactful yet compliant social media tactics.”

Rockney points to the use of medical guidelines versus approved indications as another key area where the FDA has used Untitled Letters to make its perspective clear.   “Companies should be more aware that even if a medical guideline recommends a particular use, this use may not be consistent or as restrictive as the FDA approved indication. It’s important to evaluate a particular section of a medical guideline to make sure it doesn’t potentially expand the use of the product beyond the FDA approved indication.”

“The impact of clinical trial design on claims is another important consideration,” says Rockney.

“If you carefully review the OPDP enforcement actions over the past few years, the letters clearly communicate the impact of the trial design in defining what is acceptable for promotion. It’s not just the FDA-approved label that determines marketing parameters, but the particulars of the trial design are critical as well.”

Based on these perspectives, I decided to probe further to hear whether the industry could expect more good news.

According to Wayne Pines, a former FDA associate commissioner, member of the Marketing Pharmaceuticals Program Committee for every conference since its inception in 1989, and CCC’s Advisory Board Chair, FDA has agreed to “engage in a comprehensive review of the regulatory policies governing communications about medical products.”

“Everyone involved in promotional review should take advantage of the current open environment to discuss and be prepared to provide to FDA ideas for how this area should be regulated.   This will be a significant opportunity for the industry to provide input.”

Industry’s commitment to establishing highly efficient review processes is another reason why marketers can look forward to getting more promotional materials into the field more quickly.

For example, experts agree that concept reviews provide an excellent opportunity to discuss novel marketing tactics with review committee members or in partnership with regulatory early in the development process or before committing sizeable resources to the project.

Hopkinson, who joined the DIA Marketing Pharmaceuticals program committee this year, explains that “when we are able to review ideas in the concept stage, well before the piece begins to evolve, the process is much more efficient. Significant changes suggested later in the process often create delays and added expense.” She continues: “Companies should also make sure they are working with promotional agencies that have good regulatory acumen and are satisfying the basic regulatory requirements in the piece.”

Pines concurs: “The value of understanding regulatory boundaries extends to promotional agencies because they typically originate promotional copy for review and approval.”   Data published in the DIA Global Forum links longer internal review cycles to promotional agency knowledge gaps that lead to unnecessary rewrites. It is estimated that 25% of a regulatory reviewers’ time is wasted redlining materials submitted by agencies that included clearly non-compliant elements.   This can translate into significant costs.

“Promotional agencies must master regulatory fundamentals relating to risk communication, fair balance and broadening claims because the FDA will continue to flag these content violations,” asserts Pines.  “Omission or minimization of risk information was the violation most commonly cited in six of the seven Untitled Letters issued this year to date.  And digital issues represented half of the violations cited in the Untitled Letters.”

In addition to requiring that agencies demonstrate regulatory compliance competency, companies are investing in their cross-functional promotional review teams to drive efficient review processes. A rock-solid understanding of the regulations and guidances is the foundation. “Newly-hired or less-experienced staff members should be closely mentored and not deployed to a team until they have clearly demonstrated the capability of working independently,” Rockney says. Not coincidentally, Rockney is the Chair of a newly formed working group within the DIA Regulatory Affairs Community, the AdPromo Working Group, which serves as a forum for study and information sharing on fundamentals and recent developments in ad promo compliance.

Promotional review excellence is key especially as OPDP re-evaluates its draft guidances, potentially moving the boundaries within which marketing and promotion must create. For example, the Draft Guidance issued in 2009 on the Presentation of Risk Information in Prescription Drug and Medical Device Promotion is under re-evaluation.

“It will be really interesting to see if OPDP makes any significant changes to the type and amount of safety information that that they currently expect to see included,” says Hopkinson. “OPDP has also been re-evaluating the 2004 draft Guidance on the Brief Summary and disclosing risk information in Consumer Directed Prints Ads. Currently there is a lack of standardization across industry on the format of the Brief Summary with manufacturers using little to no white space or very small font sizes to accommodate all the risk information in as little space possible. The revised Guidance could result in manufacturers being required to purchase additional print advertising space.”

Pines adds that changes related to Google search engine optimization (SEO) will also require regulatory compliance know-how. One of the most common SEO practices – loading exact matching keywords onto a page – will now result in a lower SEO ranking, as a penalty. To achieve a higher ranking, marketers must actually avoid exact matching of keywords in content and instead tag content (text and/or images) with keywords or parts of phrases relevant to a popular search query. Read this article in PM360 for more information on these changes.

Indeed, life science companies are facing increased pressures to ensure that promotional materials meet strict regulatory standards and various local codes of practice around the world. However, Martin Skelton, of agency holding company IPG notes, “once client and agencies are familiar with regulations around promotional materials, they can still stretch their creative wings with the clarity and freedom that comes from a thorough understanding of the rules.”

Laura Schoen, President, Global Healthcare, Weber Shandwick agrees: “We welcome greater clarity about the regulatory framework, especially given the relevance of digital channels for healthcare communications.”

Putting a fine point on whether regulatory requirements actually unshackle promotional creativity among marketers, Wendy White, CEO Siren Interactive says, “Having helped four companies in the rare disease space make their first foray into social media, we embrace regulatory requirements, which can lead to great creative exercises in campaign development.  It’s amazing what ultimately rises to the top if all stakeholders are aligned in a collaborative effort.”

Stephanie Bova, Senior Director, Global Commercial, General Medicine, Takeda, sums it all up: “Working effectively in our regulated environment can result in quantifiable benefits including claims optimization, agility around approval of cutting edge campaigns and the possibility to use some of the agency hours saved to start additional value added projects.”

To drive more efficient promotional review processes and effective risk management, marketers and their external partners must submit compliant content. Knowing where the boundaries lie removes the constraints of doubt, allowing creative partners, marketing teams and review teams to work freely, creatively, and effectively.