Originally posted on Compliance Center by Ilyssa Levins and Debra Michaels
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In fact, the publication of five draft guidance documents in 2014—three on social media—will help pave the path for increased product promotion activities in 2015, according to Hopkinson.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.”
Read the full article at PM360Online and learn more at the Advanced Learning Institute’s Strategic Multi-Channel Marketing for Pharma summit in Washington, DC this April.