Promotional Review Best Practices: Mitigating Risks, Maximizing Success
Richard Lawson, Partner, Consumer Protection, Manatt, Phelps& Phillips, LLP
Jeremy Lutsky, Partner, Manatt Health, Manatt, Phelps & Phillips, LLP
Discover How to Meet Commercial Goals While Complying with FDA and FTC Regulations.
The promotional review process requires a critical balance between ensuring materials achieve business goals and complying with regulatory constraints. There often can be friction on the promotional review committee (PRC) between the marketing team and participants representing medical, legal and regulatory issues. But in the end everyone has the same core objective—optimizing commercial success while keeping the company safe.
How can you reduce conflict on the PRC and work together efficiently across different functions to achieve a common goal? What are the Food and Drug Administration (FDA) regulations you need to keep top of mind when evaluating messaging—and how does the Federal Trade Commission (FTC) come into play for life sciences advertising? What are best practices for “fighting fair” on the PRC—and reaching the optimal result for your brand? Learn the answers at an all-new Manatt webinar.
Key topics include:
- The distinct roles and responsibilities of the PRC players—marketing, medical, regulatory and legal
- Best practices for managing conflict, working effectively and meeting the goals of all parties
- A guide to balancing commercial interests vs. medical, legal and regulatory concerns
- Key FDA regulations, published guidance and processes—including fair balance and limitations on off-label marketing and unsubstantiated competitive claims
- Application of recent payer and provider guidance (Medical Product Communications That Are Consistent with the FDA-Required Labeling—Questions and Answers or CFL Guidance) expanding the ability to engage in pre-approval and label consistent discussions
- The role of the FTC in pharmaceutical advertising, including an overview of state and federal laws and enforcement structures
- The working relationship between the FDA and the FTC—and how states come into the mix
- A deep-dive into claims substantiation laws and cases attorneys general have brought against pharmaceutical companies, including potential sanctions—and lessons learned
- Real-world case studies illustrating how complex issues can be addressed and resolved
The session is valuable to executives and team members of functions involved in developing, reviewing and approving marketing materials, including:
- Marketing/Advertising/Sales Promotion
- Brand and Product Management
- Regulatory Affairs
About the Sponsors
Manatt Health combines legal excellence, first-hand experience in shaping public policy, sophisticated strategy insight and deep analytic capabilities to provide uniquely valuable professional services across the full range of health industry players. Our 160+ attorneys and consultants from Manatt, Phelps & Phillips, LLP, and its consulting subsidiary, Manatt Health Strategies, LLC, are passionate about helping clients advance their business interests, fulfill their missions and lead healthcare into the future. Visit https://www.manatt.com/health.For more information please visit www.manatt.com/health.