The Full Spectrum Blog

Earlier this year, we suggested a session topic for the Food and Drug Law Institute’s “Advertising & Promotion” conference, and today’s the day of the session we recommended, on the second day of the two-day FDLI conference.

For an hour, we undertook the subject “Instilling Quality in Promotional Communications From Start To Finish: Effective Collaboration With Marketing and Media Companies.”

I moderated a panel of thought leaders from Daiichi Sankyo (Alan Bergstrom, Senior Director, Commercial Regulatory Affairs), the Center for Communication Compliance (Ilyssa Levins, President and Founder), Zinc Ahead (Hamish Miller, Director of U.S. Operations), and Preeti Pinto and Associates (Preeti Pinto, President).

The session explored how health products companies could more effectively work with their marketing partners, public relations firms and advertising agencies to reduce if not avoid costly delays in the approval of communications materials and programs.

In planning the session with the presenters, I was quite surprised to learn about the additional costs in delays and resources due to the lack of better coordination between the pharma brand teams, their marketing partners and a company’s internal regulatory affairs staff.

For instance, Hamish shared that companies worldwide consistently cancel 15% of planned promotional material, taking as many as 3.5 rounds of review to get material approved. Ilyssa reported her insights that knowledge gaps – such as her anecdote that one-third of participating senior PR agency staff failed a 12-question test on regulatory compliance after three attempts – drive the additional costs, and that optimal training on the details of compliant communications can actually enhance the value regulatory provides to the commercial end of things.

Alan emphasized that companies own an opportunity to improve the drug or device marketing program process by making regulatory departments part of the core team and clarifying expectations regarding authority and decision-making for reviewers, as well as seizing the opportunity to close knowledge gaps via training and testing. Finally, Preeti laid out a proposed pathway to change market behavior by optimizing claims, regulatory compliance and more efficient processes and clearly communicating and developing regulatory guidance and processes.

In preparing my comments, I got the idea to review RFPs that Spectrum has received over the past 18 months and selected prime examples of language in those RFPs that would probably scare some of the regulatory people at the very pharmaceutical firms that would like to do business with firms such as Spectrum. I suggested that companies should bring their brand, regulatory and corporate procurement teams in alignment before developing and sharing RFPs or statements of work (SOWs) in order to promote compliance with FDA advertising and promotion communications guidelines and regulations.

You can obtain a copy of the slides of all the presentations that took place at the conference over the past two days by accessing the FDLI website.

The bottom line with achieving full regulatory compliance in pharma marketing communications is to get it right in the first place. At the end of the day, beginning with an open dialogue and alignment among all parties is good for business; everyone wins. And then the going goes so much more smoothly.