The 4th Promotional Review Committee Compliance & Best Practices, sponsored by ExL, was chock full of information designed to improve the effectiveness and efficiency of promotional review committees. The event, moderated by John Marcus, Associate Director, Regulatory Affairs at AbbVie, and Rebecca Rivera Torres, MS, RD, CSSD, Senior Promotional Review Associate at United Therapeutics, tackled such thorny issues as overcoming the hurdles of reviewing search engine marketing techniques, reviewing adaptive promotional websites, simplifying the review of co-promoted drugs, approving materials for medical scientific liaisons (MSLs), and reducing late submissions.
“With the FDA regulations ever evolving, this biannual event offers a prime opportunity to discuss innovative promotional ideas that are being implemented now and those on the horizon,” states Torres. “Key members of promotional review committees from across the pharmaceutical and biotech industries come together to brainstorm ideas to resolve issues that arise during the review of sales, marketing, and training materials, with the end goal of optimizing the process for the industry’s benefit.”
Planning Models
“A well-developed review process requires a planning model that meets goals for consistency, efficiency, compliance, and accurate and adequate resources,” states Elizabeth Theophile, Director, Promotional Materials Compliance Management, Commercial Strategic Operations at Sunovion Pharmaceuticals. “This planning model should be implemented early in the process and must have the support of leadership.”
Co-Promoted Products
According to Marcus, early collaboration is key for co-promoted products where the review of promotional materials involves multiple stakeholders. “To simplify the process while building relationships, companies must set early expectations, define roles of each team member, make decisions together, and use previous experiences to explain comments and discuss processes.”
Overcoming Roadblocks
UCB has undertaken a comprehensive effort to create a highly efficient review process that overcomes roadblocks commonly experienced by manufacturers. These can include turnover in marketing teams/agency partners, limited review experience, and incomplete knowledge of advertising/promotional regulations.
“Content creators need to know basic FDA regulations and requirements; company policies and guidelines; product information/data and brand information,” underscores Ariail Roberts, Senior Manager, Review Services at UCB.
According to UCB’s Jan Jeffords-Schenck, Associate Director Review Services, the company is embarking on a comprehensive initiative that begins early in the review process to streamline reviews, reduce duplication, and drive a co-creation mindset among all stakeholders.
Specifically, the initiative combines live onboarding training, formal certification processes, and mentorships for content originators. Additionally, continuing education features stakeholder meetings and webinars to share challenges and best practices, and discuss hot topics and dissect FDA letters. The company is in the process of developing a training curriculum with an entry-level assessment test to quantify baseline knowledge and focus on specific training needs.
FDLI and Mobile Apps
Like the ExL conference, the Food and Drug Law Institute (FDLI) addressed the use of mobile apps in a panel format featuring diverse perspectives from marketing, communications, and policy.
“The FDA is very supportive of apps that advance the public health through promotion of safe use and outcomes support,” says Peter Pitts, a former FDA official who is currently consulting in this area.
Shalu Bhambhani, Business Insights and Operations Manager, Shire Leadership Development Program, adds, “There are so many opportunities to deliver on public health needs for patients, caregivers, and providers.” Bhambhani suggests working with review teams to execute live pre-tests of desired app functionalities in a secure testing environment. “Another best practice is to ensure consistency across teams regarding regulatory compliance requirements. It’s important to level set expectations by training and testing team members to overcome any variations in knowledge and experience which can slow down reviews.”
Alexis Pone, Vice President, Account Supervisor at JUICE Pharma Worldwide, says, “The prospect of developing a new medical app is equal parts exciting and daunting. Marketers often feel paralyzed by pre-conceived notions about regulatory constraints, lack of regulatory digital acumen, and unclear or under-communicated company guidelines, all of which can impede app development.”
On a final note, Pitts, who is now Chief Regulatory Officer at Adherent Health, adds, “There’s a difference between what’s in compliance and what a company views as its own internal best practices.” That needs attention.
