Navigating the FDA’s established legal requirements for advertising and promotion of regulated products can be confusing. Interpretations of statutory language and the integration of psychological principles creates a new venue for FDA enforcement criteria. Social media creates new boundaries and pitfalls for manufacturers that create new and onerous obligations despite the corresponding benefits of direct-to-consumer advertising. Mass media and internet platforms create new avenues for communication, but the regulatory guard rails to stay compliance with FDA’s requirements are not always clear and they evolve in unexpected ways. The seminar will cover topics that equip you with the knowledge and skills required to avoid the FDA’s enforcement hammer.
The FDA regulates firms’ advertising and promotion of products. The information may not be false or misleading and include adequate information about the risks versus benefits of a product. The concept of “labeling” incorporates relatively new platforms based on internet platforms and social media. The direct nature of communication to consumers relies, in part, on how someone cognitively processes information and acts accordingly. Constitutional case law has shaped how the FDA can and cannot regulate commercial speech, i.e., labeling. At the same time, the FDA applies its interpretations of statutory language in surprising ways
Key Learning Objectives
- Interpret the FDA’s statutory language for labeling
- Understand the relevant Constitutional Law
- Learn how case law has shaped FDA’s regulation
- Identify the dangers of social media promotion
- See how FDA’s use of cognitive psychology affects marketing
- New Corporate Responsibility
6.0 RAC CREDITS
RAPS - This course has been pre-approved by RAPS as eligible for up to 6 credits towards a participant's RAC recertification upon full completion.
Agenda
- Statutory requirements and FDA’s Regulatory Interpretation
- Constitutional Law
- First Amendment Protection
- Commercial vs. Individual Free Speech
- Controlling Supreme Court Cases for Government Actions
- FDA Guidance and How to Follow It
- Social Media as Labeling
- FDA’s Use of Cognitive Psychology Principles to Evaluation Promotional Information
- Risk / Benefit Information and the Consumer Decision Process
- Case studies and hypotheticals
- FDA’s Expectation of Corporate Policy
- FDA Warning Letters and Untitled Letters
- Overlapping Federal Laws for Advertising and Promotion
- FDA’s Position of Corporate Responsibility
Speakers
Mr Casper (Cap) Uldriks,
Former Associate Center Director ,
FDA's CDRHThrough his firm “Encore Insight LLC,” Casper brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.
Who Should Attend
- Sales and marketing executives and managers.
- Regulatory managers
- In-house legal counsel and contract specialists
- 3rd party consultants
- Venture Capitalists
- Investors Business Acquisition Executives
- Owners of new or developing firms
- Own-label distributors
- International Trade Managers
- Product specification developer
- All Regulatory consultants
- Compliance specialists
- Food, drug, and medical device attorneys
- Marketing representatives
- Medical communications professionals
- Medical affairs
- Medical writing
- Medical Science Liaisons (MSLs)
- Clinical research professionals
