Ian Demeritt, a member of Fingerpaint’s medical strategy team, recently spoke at ExL Events’ Promotional Review Committee Compliance & Best Practices conference about PRC meetings from an agency’s perspective.
He provided tips on how companies can best collaborate with their agencies. Demeritt shared some of this advice and takeaways from the conference.
Briefly tell us about your presentation.
Not surprisingly, the pharmaceutical marketing world is highly regulated. To ensure that they don’t run afoul of the law, each pharmaceutical company has a team responsible for ensuring that their marketing pieces are truthful, non-misleading, and follow the plethora of rules and laws outlined by federal regulations. These teams, commonly referred to as the Promotional Review Committee — or PRC — are typically made up of reviewers specialized in the fields of medicine, law, and regulatory affairs (in addition to a marketing representative). Prior to dissemination, each promotional piece must be reviewed and approved by each of these disciplines.
Marketing agencies are typically tasked with writing, designing, and producing marketing pieces, and it is often the work of agencies that is being reviewed and discussed in these PRC meetings. As a result, it is essential that there be a good working relationship between not only individual members of the PRC team, but also the PRC teams and their agency partners. Unfortunately, this is not always the case, and agency partners do not always feel like much of a partner during PRC reviews.
The goal of my presentation was to discuss the PRC process from the agency point of view and to offer suggestions on how to improve the agency-PRC relationship. I tried to highlight some of the challenges that PRC teams and agencies face when working together, using the results of an agency-wide survey as support. I finished my talk by identifying 4 key areas of focus to improve and maintain the relationships between our teams: connection (creating an open dialogue); communication (providing clear and consistent feedback); collaboration (working together as partners); and courtesy (maintaining a respectful relationship).
What do you hope conference attendees took away from your talk?
If there’s one thing that I hope attendees remember about my talk, it’s that we are all on the same team. We may approach marketing communications from different angles, but in the end, we all have the same goal in mind: to do what is best for the patient in a compliant manner. Once there is a mutual understanding that we are all working toward the same end, many of the defensive walls can be broken down as we work together on finding a collaborative solution to address issues raised during PRC reviews.
What did you find most interesting about the conference?
As an agency, our interactions with PRC team members are often limited to weekly review meetings where they act in their professional capacities and seldom break character. As a result, we never really get to interact with the reviewers as the interesting people they actually are. One thing I really enjoyed about this meeting was that it provided a chance to get to know the PRC teams on a personal level and interact with them in a real-world setting. I think that both agencies and their PRC teams should look for opportunities to get to know each other on a personal level outside of formal PRC meetings.
Of all the presentations, was there one that stood out to you most?
One theme that seemed to carry through many of the presentations was the need to adapt to new trends, especially in the digital space. Technology is changing fast, and PRC teams will be tasked with figuring out how to best implement these new applications. For example, voice search technology is being rapidly adopted by consumers, yet introduces a slew of new challenges when it comes to pharmaceutical marketing (i.e., is Alexa really going to read 5 minutes’ worth of Important Safety Information before answering whether you need to take your new prescription with food? Will consumers who increasingly want immediate information have the patience to sit through it?).
With a lack of formal guidance from the FDA in many of these areas, there will be a need for companies to establish their own internal policies for implementing such tactics based on their individual level of risk tolerance. It will also be increasingly important for PRC teams to collaborate with their agency partners in order to come up with creative, yet compliant, solutions to these questions.
How did attending the conference help you in your everyday role at Fingerpaint?
I think there is often a perception that agencies want to sneak something past PRC teams. The reality couldn’t be further from the truth. In fact, the medical team at Fingerpaint invests considerable time reviewing and discussing FDA warning letters, guidance documents, and PRC feedback in order to make sure that everything we produce is within FDA regulations.
This conference provides a great opportunity not only to learn firsthand about trends and best practices in the regulatory space, but also to be an active part of the conversation. PRC plays a key role in every account we work on at Fingerpaint and building a stronger partnership with our clients — including PRC — is paramount to our success as a company and the success of the brands on which we work.