Conventional wisdom holds that the best way to boost a team’s creativity is to unshackle them from constraints. But innovation expert Adam Richardson, in his Harvard Business Review blog post entitled “Boosting Creativity Through Constraints” counters this perspective and uniquely asserts 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.
That’s good news for healthcare marketers and promotional agencies responsible for developing compelling and creative ideas compliant with government requirements. And to explain why, we spoke with experts including Tracy Rockney, Vice President, Regulatory Affairs, Global Labeling, Advertising & Promotion, Regulatory Policy & Intelligence, AbbVie; Lyn Hopkinson, Senior Director Commercial Regulatory Affairs, Global Regulatory Affairs, Eisai Inc.; and Wayne Pines, former FDA official and Advisory Board Chair, Center for Communication Compliance (CCC).
According to Rockney, FDA enforcement actions and guidances make it easy to establish the boundaries within which marketing and regulatory teams must work. She states, “Marketers who take the time to read them will understand what the Office of Prescription Drug Promotion (OPDP) is really trying to communicate.”
In fact, the publication of five draft guidance documents in 2014—three on social media—will help pave the path for increased product promotion activities in 2015, according to Hopkinson. She adds, “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.”
The use of medical guidelines versus approved indications is another key area where 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,” Rockney remarks. “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, according to 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,” she observes. “It’s not just the FDA-approved label that determines marketing parameters, but the particulars of the trial design are critical as well.”
A Good Regulatory Environment Ahead
Marketers have every reason to be optimistic about the regulatory environment next year. Wayne Pines, a former FDA associate commissioner, predicts that discussions about the regulatory environment will be focused. The FDA, he says, has agreed to “engage in a comprehensive review of the regulatory policies governing communications about medical products.”
That means that everyone involved in a promotional review should take the opportunity to join in the current open environment to be prepared to provide the FDA with input—ideas addressing how this area should be regulated.
And marketers can look forward to getting more promotional materials into the field more quickly. Why: Industry’s commitment to establishing highly efficient review processes. 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.
Review in the Concept Stage
Having the ability to review ideas in the concept stage, Hopkinson notes, well before the process begins to evolve, makes the process more efficient. She adds, “Significant changes that are suggested later create delays and added expense.”
Also, the value of understanding regulatory boundaries extends to promotional agencies, according to Pines, because they typically originate promotional copy for review and approval. Data published in the DIA Global Forum (http://bit.ly/1DDUUKX) links longer internal review cycles to promotional agency knowledge gaps that lead to unnecessary rewrites. In fact, an estimated 25% of a regulatory reviewer’s time is wasted redlining materials submitted by agencies that include clearly non-compliant elements. Promotional agencies must master regulatory fundamentals relating to risk communication, fair balance and broadening claims—the FDA will continue to flag these content violations, according to Pines. “Omission or minimization of risk information,” he states, “was the violation most commonly cited in six of the seven Untitled Letters issued this year to date. And digital represented half of the violations cited in the Untitled Letters.”
Safety Information Change
Companies are also investing in their cross-functional promotional review teams to drive efficient review processes. At their foundation: A rock-solid understanding of the regulations and guidances.
Promotional review excellence is key, especially as OPDP re-evaluates its draft guidances—potentially moving the boundaries within which marketing and promotion 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. Based on the FDA’s review, this could change how manufacturers currently display safety information.
“It will be really interesting to see if OPDP makes significant changes to the type and amount of safety information 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, she notes, a lack of standardization across industry exists regarding 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 as possible. Hopkinson, adds, “The revised guidance could result in manufacturers being required to purchase additional print advertising space.”
Changes related to Google search engine optimization (SEO) will also require regulatory compliance know-how. See the Compliance Center column in the September 2014 issue for more information on the 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. 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 review teams to work freely, creatively and effectively.