Moving FDA Boundaries for Direct-to-Consumer Advertising

Why Should You Attend:

Direct-to-Consumer (DTC) advertising involves various platforms to convey a message, such as broadcast media, print media, social media and the internet. Each of these platforms have special criteria to define what you can and cannot do. FDA treats those criteria in a stringent manner. FDA "trolls" these platforms to catch firms running fowl of the FDA's guidance on DTC. If they catch you, they can.

FDA’s evaluation DTC advertising covers the explicit messages, the implied messages and how the message was conveyed. The later perspective has ventured into applied principles of cognitive psychology to determine what and how a firm communicates to a consumer on the conscious and unconscious level of awareness. Firms need to be vigilant on these different levels, which creates an uncomfortable situation for regulatory affairs staff and marketing staff, neither of whom may sufficiently familiar with the issues. If firm's that do not understand FDA's regulatory approach to DTC, the consequences can be costly. This webinar will bring attendees up to speed so you are clearer about when DTC advertising makes you ripe for legal picking by the FDA.

Learning Objectives:

• Understand FDA’s limits on DTC advertising
• Learn how FDA now applies cognitive psychology principles to advertising
• Expand your awareness of messaging components that can lead you into trouble
• Conflicts between regulatory affairs and marketing
• Know that your senior executives may be barred from the pharmaceutical or medical device industry due to these issues

Areas Covered in the Webinar:

• FDA's approach to DTC advertising and promotion principles
• FDA guidance and use of cognitive psychology
• Types of violation for illegal DTC advertising practices
• Roll of sales and marketing departments
• Executives' legal liability

Who Will Benefit:

• Regulatory managers
• Sales and marketing executives
• Owners and executives of pharmaceutical and medical device firms
• Own label distributors
• International trade managers
• Product specification developers

Casper Uldriks
Former Associate Center Director, CDRH

Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” 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 (CDRH.) 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 the FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s regulations, policies and procedures into a coherent picture.

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