FDA Scrutiny of Promotion and Advertising Practices: 2-Day In-Person Seminar by Ex-FDA Official

By: Casper (Cap) Uldriks, Former Associate Center Director of FDA's CDRH
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Course Description:

If you go “off label” with advertising and promotion, you become embroiled in FDA’s advertising and promotion requirements. For devices, the law is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments need to collaborate now more than ever before. Firms need to identify practical criteria to make marketing decisions. The big question is whether or not marketing managers and regulatory affairs managers will really try to reach common ground. FDA’s Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. FDA’s Center for Drug Evaluation and Research (CDER) uses long-standing regulations and a growing number of guidance documents in its regulatory approach. Policing social media has become a new regulatory responsibility. Bottom line, do you know when you are running afoul of FDA’s requirements or are you guessing? Can you afford to guess? The cost to your business and the confusion left in your customer’s mind becomes an unwelcomed nightmare.

Seminar Instructor Casper Uldriks is an “Ex-FDA Official” who has spent 32 years in FDA and his engagements focus on advertising and promotion, recalls, corrections and removals and enforcement. He currently trains FDA personnel and counsels clients on wide range of topics, including: FDA inspections; import operations; advertising and promotion; corrective and preventive actions; medical device reporting and corporate reorganization to improve conformance to the FDA’s requirements.

With this seminar you will learn how to navigate FDA’s numerous legal options and how to interpret them based on basic legal principles. Applying new guidance documents becomes a new test of the FDA’s legal boundaries and enforcement options. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This academic discipline may or may not get to the root of what consumers take away as the message. What is more challenging is whether a consumer’s mind makes its decisions on what it learns versus pre-existing emotional factors that may or may not be conscious.

This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm’s regulatory profile for advertising and promotion practices. What is not so easy is to know is how the potential customer or existing user will actually make their decision and act on it.

Learning Objective:

  • Learn how FDA faces constitutional constraints on enforcement decisions
  • Learn about intersecting federal requirements by the Department of Justice, the Federal Trade Commission, the Securities and Exchange Commission and the Consumer Product Safety Commission
  • Learn how the FDA interprets advertising and promotion in principle and in fact
  • Understand ways that a firm violates FDA requirements
  • Evaluate advertising and promotional material based on interactive group hypotheticals
  • See how sales and marketing departments play a central role, for better or worse
  • Learn how the federal government holds executive management responsible for missteps in promotion and advertising practices.

Who will Benefit:

  • Sales and Marketing executives and managers
  • Regulatory Managers
  • In-house Legal Counsel and Contract Specialists
  • 3rtd party consultants
  • Venture Capitalists
  • Investors
  • Business Acquisition Executives
  • Owners of New or Developing Firms
  • Own label distributors
  • International Trade Managers
  • Product specification developers

Topic Background:

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. The vehicle for communication has evolved dramatically over the past 100 years and continues to evolve at a rate faster than one can anticipate at times. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the legal field playing field involves other federal agencies and departments, and they work in concert with FDA. It has become very complicated and very costly if you knowingly or unknowing walk into a legal snare. This seminar is designed to bring you up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

Course Outline

Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

  • FDA legal authority
    • FDA application of the FD&C Act and implementing regulations
    • FTC / mass media
    • SEC/False statements
    • DOJ / False Claims
    • Enforcement authority and options
  • Cognitive psychology vs. psychoanalytic motivation
  • Promotion and Advertising: scope of labeling
    • Definitions for “label” and “labeling”
    • Hard copy and electronic
    • Testimonials
    • Blogs
    • Sales force
    • What is “off-label”?
    • Practice of Medicine exemption
    • Drugs authority
    • Devices
    • Dietary supplements
  • Supreme Court / commercial free speech
    • Constitutional protection
    • Safe harbor
  • Policy
    • FDA organizational responsibility
    • FDA Guidance
    • Fair and balanced disclosure
    • Social media
    • Direct to Consumer Advertising
  • Hypothetical Workshop
Day Two (8:30 AM – 4:30 PM)
  • Direct to consumer advertising vectors
  • Federal Trade Commission interest (economic vs. safety)
  • Context and format of messaging
  • Script versus message
    • Target population
    • Aspirations
    • Emotional factors
  • False and misleading information
    • Statutory basis (21 U.S.C. 352(a))
    • New use
    • Comparative claims
    • Claims for safety and effectiveness
    • Sales for solicitation
  • Off label use
  • Practice of medicine exemption
  • Custom Device promotion
  • (Group Hypothetical)
  • FDA Warning Letters
  • Corporate management responsibility

Meet Your Instructor

Casper Uldriks_90x112
Casper (Cap) Uldriks
Former Associate Center Director of FDA's 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. 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.

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