FDA Scrutiny of Promotion and Advertising Practices (COM)

FDA Scrutiny of Promotion and Advertising Practices (COM)
Event on 2017-07-13 08:30:00

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.

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.

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.

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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
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.

Day 01(8:30 AM – 4:30 PM)
8:30 – 9:00 AM: Registration
9:00 AM: Session Start Time
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
Sales force
What is “off-label”?
Practice of Medicine exemption
Drugs authority
Dietary supplements
Supreme Court / commercial free speech
Constitutional protection
Safe harbor
FDA organizational responsibility
FDA Guidance
Fair and balanced disclosure
Social media
Direct to Consumer Advertising
Hypothetical Workshop

Day 02(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
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

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.

Please contact the event manager Marilyn below for the following:
– Discounts for registering 5 or more participants.
– If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

This Event Listing is Promoted by
New York Media Technologies LLC in association

at Postal code 92103, United States

San Diego, United States

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