In life science marketing, be it pharma or device, we see marketing teams walk a tightrope every day. They strive to create compelling messaging and collateral that inspires action, while also remaining compliant, accurate, and on-time. It’s an important balancing act, made in accordance with regulatory review teams (MLR, PRC, AdProm, etc)–the unsung heroes of the healthcare marketing world. Review teams not only function as experts of product prescribing information, but also as arbiters of FDA promotional communication guidelines, much of which is ambiguous and frequently updated. So, how do regulatory committees stay ahead in a dynamic and evolving environment?
Enter the Promotional Review Committee Compliance & Best Practices conferences–the only industry events devoted specifically to optimizing the skill sets, teamwork, speed, and regulatory awareness of PRC members. As one of the conference sponsors, members of Vodori attended the Chicago meeting last month, to gain insights into updated FDA regulations and to learn how we might better partner with marketers and regulatory committees alike. In a way, many of the conference panels felt more discussion than answer, which seems germane to the thoughtful interpretation and navigation regulatory committees commit to every day. Below are key insights and takeaways that took place during the conference.
New Tech–New Rules?
Digital experiences continue to push marketing boundaries–perhaps nowhere more so than at medical conferences, which are often the source of FDA enforcement letters. Conference booths straddle a line between entertainment and education, where minimization of risk and safety information is the most commonly cited issue.
Zafar Toor, Senior Director of Commercial Regulatory Affairs at Lexicon Pharmaceuticals, led a talk titled “Ensure Compliant Presentation and Successful Evaluation of Convention Materials”. Toor stressed the importance of proper risk and safety presentation on conference banners. He suggested using conceptual reviews with marketers and agencies early in booth development to check for risks and maintain the correct placement of safety information throughout a booth space. Any sort of claim or reminder-like ad (established branding) will likely need to be framed with important safety information.
Toor also reviewed the pros and cons of static and non-static display panels. Static is often low cost in production, shipping, maintenance, but your content will be “locked,” so to speak. Minor changes are off the table and safety will likely need to be presented in its entirety (no scrolling or “sticky” ISI). Whereas digital panels allow for edits and a chance to incorporate safety information into the user interface, the cost of such displays and their development can often run high. When seeking a balance, consider if changes are likely. And if so, will you have time for a PRC review before your deadline? Does your review process and software platform allow for late-stage edits made in a pinch?
A New (Virtual) World
Coffee and crepes are great, but what about Leap Motion technology depicting your product’s mechanism of action? If you’ve attended large conferences, you may have heard similar sentiments. Today, it’s not enough to see a cancer cell. Attendees expect to be teleported inside it. And who can blame them? It’s interactive. It’s colorful. And it can be educational. (Toor mentioned disease awareness campaigns using virtual reality to demonstrate epilepsy symptoms). Immersive 3D technology like Oculus has changed the way marketers share a product’s story. But it’s also raised questions about best practice, with little guidance from the FDA.
As technology evolves, PRC and best practices are nudged to evolve, too. Still, one fundamental issue remains: how to fairly and accurately present data while allowing marketing to also do their job. Some recurring questions to consider:
- Is it appropriate to gamify safety and efficacy data, such as shooting lasers at cancer cells?
- Can safety be placed at the end of an experience and will it even be watched by the user?
- Does scrolling safety information make a user nauseated?
For many teams, these are may be new concerns. But as mentioned earlier by Toor, ask these questions early using conceptual reviews, seeking to manage safety minimization concerns before agencies are too far along in development.
The Right Content, on Time
Label updates (i.e. new indication, updated efficacy and/safety data, administration content) are often good for the brand, but releasing updated collateral into the field in a timely manner can present headaches for PRC, the marketing team, and agency partners. All stakeholders work to strike a balance between quality and immediacy.
In a panel discussion titled “Conduct Both Gradual and Immediate Label Updates”, Sue Duvall, Head of North America Advertising and Promotion, Regulatory Affairs at MYLAN, reviewed label change management alongside Michael Saad of Abbvie and Christi Bruce of Sanofi. The panel discussed their various procedures, which varied from company to company.
One refrain was the same — digital collateral is commonly expected to be updated in real-time. Whereas print materials might push out to a month, negotiated based on risk. Depending on how extensive edits might be, some teams may decide to pull all out-dated material, making sales tools unavailable to sales teams. During such an event, marketing teams may consider using this time for content housekeeping. Label change management is important, not only from a regulatory requirement standpoint (making sure label is accurate and updated), but it’s an opportunity for marketing to evaluate materials and see what is and isn’t working and make updates accordingly.
To expedite new release and mitigate collateral mistakes, one pharmaceutical company has created a separate label change team, outside of the marketing PRC team. Because of the volume of collateral for a number of different therapies, these label change management teams meet monthly and are formed to hyperfocus on making real-time label changes, pushing content into the field as soon as possible.
How Vodori Can Help You
Whether your regulatory reviews are called PRC, MRL, MLR, RLM, Ad Promo, or A&P, Vodori is aware of the questions you face. We’re aware of the timelines you’re working against. And we’re aware of the tightrope you have to walk between compliance and inspiration. Between evolving technology, tight timelines, product launches and updates, we find these challenges as interesting as you do. Vodori created Pepper Flow® to simplify the promotional review process. By enabling real-time collaborative review, making in-flight work visible, and integrating with content delivery platforms, our software helps life science companies streamline the review process so they can focus on planning and executing better content.
We’re already looking forward to our next conference, Digital Marketing for Medical Devices, this August. Be sure to let us know if you’ll be there, too.