Please wait...
FDA Scrutiny of Promotion and Advertising Practices
Date
Link to Website
Organizer
Location
If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other.
FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. In contrast, 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 and FDA is still trying to figure out how to deal with it. Bottom line, do you know when you fail to meet FDA's requirements or are you guessing? Can you afford to guess? The cost to your business and the confusion left in your customers' mind becomes an unwelcomed nightmare.
In 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 is now conducting clinical studies and 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.
Congress and the new FDA Commissioner seem more sympathetic to expanding access to medical treatment before all the conclusive evidence for safety and effectiveness is evaluated by the FDA. Valid off-label information may take the lead in that direction.
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. Operating in a stovepipe environment will not work. You need to 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.
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
- 3rd party consultants
- Venture Capitalists
- Investors
- Business Acquisition Executives
- Owners of New or Developing Firms
- Own label distributors
- International Trade Managers
- Product specification developers
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.
Please contact the event manager Marilyn below for the following:
- For Registrations Please call +1 929.900.1853
- 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.
NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS
-----------------------------------------------------------------
This Event Listing is Promoted by
New York Media Technologies LLC in association
with NetZealous LLC.
http://www.NyEventsList.com
http://www.BostonEventsList.com
http://www.SFBayEventsList.com
-----------------------------------------------------------------
JAI170516EVZTODAY
Agenda
Day 1 Schedule
Lecture 1: 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
Lecture 2: 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
Lecture 3: Supreme Court / commercial free speech
Constitutional protection and case law
Amarin Case: off-label, but true
Safe harbor
Policy
FDA organizational responsibility
FDA Guidance
Fair and balanced disclosure
Social media
Direct to Consumer Advertising
Hypothetical Workshop
Day 2 Schedule
Lecture 1:
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
Lecture 2: False and misleading information
Statutory basis (21 U.S.C. 352(a))
New use
Comparative claims
Claims for safety and effectiveness
Sales for solicitation
Lecture 3:
Off label use - practices and policy
FDA Warning Letters
Lecture 4:
Practice of medicine exemption
Custom Device promotion
(Group Hypothetical)
Corporate management responsibility
Speaker Details
Casper Uldriks
ex-FDA Expert and former Associate Center Director of CDRHCasper (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.
Event Categories
|
VIP Life Time Subscription to our Newsletters!
$299.99
|
