FDA Scrutiny of Promotion and Advertising

Overview:

DTC may be deemed as misbranding your product and, therefore, may not be marketed. Firms must be more sophisticated now in designing their advertising methods and messages. The days of looking at text alone for a magazine insert are long gone. You should pay attention to the components of your advertising in mass media, such as volume; images; information prominence and conspicuousness; speed of the message subliminal messaging and "the take away message." This means you need to understand what each component of the advertising attempts to accomplish and then evaluate the integrated message, i.e., the "take away." The difficulty is that this broad horizon of factors gives the FDA abundant opportunities to say that you have misbranded your product. Hence, it is illegal.

Why should you Attend:

If you do not anticipate how the FDA will view and interpret your advertising and how you monitor it, you could be making a marketing launch that falls into the abyss of an enforcement action. That is expensive and leaves you with a cloud over your name at the FDA. That is never a good thing. You must know what you are doing with DTC advertising, not just hope you do. You will probably earn a Warning Letter by "Winging it." Make no mistake, the FDA will take their logic beyond rational boundaries, and you will pay the consequence. You need to keep up with the defined boundaries of DTC advertising and promotion to avoid FDA scrutiny.

Areas Covered in the Session:

• FDA's approach to DTC advertising and promotion principles
• FDA guidance and use of cognitive psychology
• Types of violation for illegal DTC advertising practices
• The role 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 Developer

Speaker Profile

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. 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. Professional credentials: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.

Others Details

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