They don’t have to be and as the data presented at a recent conference revealed, the reality is that when commercial and compliance collaborate to close regulatory knowledge gaps within marketing departments and promotional agencies, it drives greater efficiency, effectiveness and impact.
Looking for a magic potion to speed up the promotional review of creative, high impact marketing materials? Try fostering collaboration between commercial and compliance, which drives the business and reduces risk.
This was a key message I shared during an October panel discussion at the Food and Drug Law Institute (FDLI) meeting in Washington, D.C. My co-presenters concurred.
Daiichi Sankyo’s Senior Director of Commercial Regulatory Affairs Alan Bergstrom offered a clear plan to achieve this goal of enhancing collaboration:
1. Pinpoint regulatory compliance knowledge gaps among internal marketing departments and promotional agencies that disrupt and slow down the review process.
2. Qualify all staff involved in the promotional process through regulatory compliance training and testing so everyone has the same baseline of knowledge.
3. Change the current promotional review process by bringing regulatory and legal into the Brand planning process earlier.
Pinpointing The Knowledge Gaps
Knowledge gaps among internal marketing departments and promotional agency teams create inefficiencies and financial waste, according to data fielded by Rx Compliance Report, and the results from certification tests validated by former FDA officials. The findings indicate that the review process takes longer because marketing and their agencies submit non-compliant materials that require extensive rewrites.
Data show that marketing and agency staffers incorrectly answer basic exam questions on how to communicate risk, execute reminder and disease state awareness ads, and appropriately deploy spokespeople. [Test your basic knowledge by taking a sample test here: http://www. communicationcompliance.com/go/Static/ industry_sampler. Results, which are anonymous, will be available immediately.]
Agencies with knowledge gaps force regulatory to lose an estimated 40 hours per month in rewriting noncompliant promotional materials, another study finds. This is equivalent to an approximately $200K per year per regulatory professional. This doesn’t even take into consideration time lost by legal, compliance or marketing.
When staffers at promotional agencies submit noncompliant promotional materials, the agencies themselves can spend an additional $100-150K per product per year on rewrites. Wouldn’t these monies be better utilized to fund more marketing materials, or to create an entirely new campaign?
Qualify All Staff
Regulatory executives are not surprised by these results (in fact, they remark that the problem is probably worse), and savvy marketing executives understand the data’s value right away. That’s why pioneering companies are referencing these findings to make a solid business case for mandating comprehensive regulatory education that includes both training and testing. This is the ideal situation—when regulatory and marketing team up to help further their company’s culture of compliance and advance the business.
Bergstrom pointed to his own company’s move to train and test all members of marketing, managed care, and sales training, as well as their agencies, to qualify them on basic FDA regulation of advertising and promotion.
“Training without testing won’t diagnose knowledge gaps,” he said. “If we don’t know what we don’t know, we can’t take the appropriate steps to address areas of concern.”
Bergstrom asserted that all relevant employees—including regulatory—should be qualiﬁed through certiﬁcation testing before being allowed to initiate promotional tactics and take part in a Promotional Review Committee.
Change Current Review Process
Preeti Pinto, President of Preeti Pinto and Associates and former Executive Director/Head of Promotional Regulatory Affairs at Astra-Zeneca, agreed that consistent, comprehensive education gets everyone on the same baseline. “Promotional review committee meetings should be spent optimizing claims and the promotional value of a marketing piece, not wasting time on rewrites,” she said.
Like Bergstrom, Pinto believes it’s time for a change in the current review process, including making regulatory professionals a part of the core (versus extended) brand team. Earlier involvement of regulatory in brand planning would mean that problems and issues could be identiﬁed and corrected before concept execution.
Other Opportunities For Collaboration
Our panel moderator John Seng, President and CEO of PR agency Spectrum, said that requests for proposals sent to agencies by marketing teams in search of creative ideas must be aligned with regulatory parameters. Seng suggested that companies bring their brand, regulatory, and corporate procurement teams in alignment before developing and sharing RFPs or statements of work.
Measuring The Impact
Zinc’s U.S. Operations Director Hamish Miller reviewed data on the promotional review process from the last 11 years as part of his panel presentation. During that time, Hamish observed varying degrees of quality of more than 500,000 pieces in over 165 countries. “Some companies take twice the industry average to review material. Other companies take 3.5 rounds of review to get material approved. In other cases, 15% of material is consistently cancelled.”
Regulatory/Legal Can Be Marketing’s Greatest Ally
Fostering greater collaboration between promotional regulatory/legal and marketing/ product management does much more than reduce company risk, as a closer working relationship between these two stakeholders fuels marketing excellence. It’s common sense: reducing the number of rewrites required for heavily redlined marketing materials submitted by untrained staffers increases efﬁciency. Fewer rewrites free up regulatory to focus on improving the quality of claims and increases the effectiveness of the material. Plus, regulatory-savvy marketers know how to present potentially viable ideas in compliant terms from the outset, reducing the number of ‘non-starter’ concepts. Sales materials get into the market more quickly because rewrites don’t delay the review process. Finally, shorter review cycles and more effective promotion accelerate the transfer of accurate and balanced information about drugs and devices, which is critical in protecting public health.
With a ﬁrm commitment to collaboration between commercial and compliance, companies will have created their own magic potion for a smooth, cost-efﬁcient review process and an enduring strategy for success in an ever-tightening regulatory climate.