RAPS: This course has been pre-approved by RAPS as eligible for up to 10.0 credits towards a participant's RAC recertification upon full completion.
Course Overview
In today’s competitive life sciences market, understanding the complex U.S. regulations governing drug and biologic promotion is essential for compliance and success. This 2-day live online training is designed for professionals in Regulatory Affairs, Legal, Compliance, Medical Affairs, and Marketing who are involved in the advertising and promotion of prescription drugs and biologics.
Led by industry experts, this interactive seminar provides a complete overview of FDA (OPDP/APLB) and FTC promotional requirements, enforcement trends, and best practices for compliant promotional review. Participants will learn how to navigate Promotional Review Committee (PRC) processes, avoid common pitfalls, and effectively manage digital and social media promotions in accordance with FDA policies.
Through case studies, group discussions, and practical tools, you’ll gain the skills to confidently ensure your organization’s promotional materials meet all regulatory and legal standards.
Learning Objective
- Understand FDA and FTC regulations for drug and biologic advertising and promotion
- Learn how to implement compliant review processes and avoid enforcement risks
- Explore real-world case studies and recent FDA enforcement letters
- Gain practical insight into digital, social media, and disease awareness campaigns
- Strengthen collaboration within your Promotional Review Committee (PRC)
- Receive a Certificate of Completion to validate your expertise
Course Agenda
Day 01:
Regulatory Foundations and Core Principles
Session 1: Introduction and Regulatory Overview
- The U.S. regulatory framework for prescription drug and biologic promotion
- Key agencies and their authority: FDA, OPDP, APLB, and FTC
- Legal and compliance landscape — what companies must know
- Understanding labeling, advertising, and promotion definitions
Session 2: FDA and FTC Regulations in Practice
- FDA’s role in regulating prescription drug promotion
- FTC’s authority over non-prescription and consumer health communications
- OPDP enforcement trends and APLB expectations for biologics
- Case studies: Recent enforcement actions and their implications
Session 3: Promotional Material Review and Substantiation
- Core FDA requirements: truthfulness, non-misleading claims, and fair balance
- Substantiation of claims — adequate evidence and clinical data
- Required disclosures, risk information, and product labeling considerations
- Common compliance pitfalls in advertising and labeling
Session 4: The Promotional Review Committee (PRC)
- Structure and key roles within the PRC (Regulatory, Medical, Legal, Marketing)
- The end-to-end review and approval process
- Building an effective cross-functional collaboration model
- Managing conflicts, documentation, and version control
Day 1 Wrap-Up
- Summary of key concepts
- Group discussion: Common challenges and practical solutions
Day 02:
Advanced Topics and Emerging Trends
Session 1: Advanced Compliance Issues and Best Practices
- Risk management in promotional activities
- Pre-approval communications and investigational product promotion
- Reminder ads, institutional, and disease awareness communications
- Press releases and investor communications — what’s allowed
Session 2: Digital and Social Media Promotion
- FDA guidance on internet and social media platforms
- Interactive media: websites, blogs, and third-party content
- Best practices for digital advertising, influencer engagement, and sponsored content
- Managing product promotion on LinkedIn, X (Twitter), YouTube, and other platforms
Session 3: Enforcement and Case Studies
- FDA Warning and Untitled Letters — key lessons
- DOJ and FTC enforcement patterns
- Risk assessment and compliance monitoring frameworks
- Interactive analysis of real-world case studies
Session 4: Future Trends and Practical Takeaways
- Current and emerging FDA policy directions
- Integrating compliance into marketing strategy
- Tools and templates for effective promotional review
- Open Q&A — discussion of participant challenges
Day 2 Wrap-Up
- Key insights and action points
- Certificate of Completion and closing remarks
Who Will Benefit
This workshop is tailored for professionals involved in or supporting the advertising and promotion of prescription drugs and biologics. It is ideal for those seeking to strengthen their understanding of FDA and FTC compliance expectations, enhance internal review processes, and stay current with evolving regulatory trends.
Participants may include:
- Regulatory Affairs Professionals – overseeing promotional compliance and submissions
- Regulatory Strategy Teams – shaping effective Ad Promo review strategies
- Legal and Compliance Leaders – managing risk and ensuring alignment with industry standards
- Medical Affairs Professionals – providing scientific accuracy and medical validation
- Marketing & Communications Teams – developing compliant promotional content and campaigns
- Promotional Review Committee (PRC) Members – contributing to cross-functional review and approvals
- Regulatory & Compliance Consultants – advising clients on promotional best practices
-
Early-Career Professionals & Students – pursuing foundational knowledge in U.S. Ad Promo regulations
✅ Frequently Asked Questions (FAQ)
1. Who regulates the advertising and promotion of prescription drugs and biologics in the U.S.?
The Food and Drug Administration (FDA) oversees prescription drug and biologic promotion through the Office of Prescription Drug Promotion (OPDP) and CBER. The Federal Trade Commission (FTC) regulates advertising for over-the-counter products.
2. What is considered “promotional” material under FDA guidelines?
Promotional materials include print ads, TV/radio spots, digital ads, websites, social media posts, sales aids, email campaigns, brochures, speaker program content, and booth materials—essentially any communication that markets a product.
3. Can companies promote off-label uses of drugs or biologics?
No. Off-label promotion is prohibited. Promotional communications must align strictly with the product’s FDA-approved labeling, including indications, dosage, and limitations.
4. What is the role of OPDP in enforcement?
OPDP reviews promotional materials, issues Untitled Letters and Warning Letters, and ensures companies correct misleading statements and cease noncompliant promotions.
Faculty David Dills
David Dills is a Global Regulatory Affairs and Compliance expert with over 35 years of experience in pharmaceuticals, biologics, and medical devices. He specializes in global regulatory strategy, FDA and international submissions, and advertising & promotional compliance, supporting products from early development through marketing authorization.
He has extensive experience working with FDA and global health authorities, developing regulatory strategies, managing complex projects, and ensuring compliant promotional review processes (MLR/PRC).
