FDA Scrutiny of Promotion and Advertising Practices Seminar

Global Compliance Seminars

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.

Course Description

Date:May 17th & 18th, 2018

Time:9:00 AM to 4:30 PM

Address: DoubleTree by Hilton Philadelphia Airport 4509 Island Avenue, Philadelphia, PA 19153

Price:

Price: $1,295.00 (Seminar Fee for One Delegate)

Until April 10, Early Bird Price: $1,295.00 From April 11 to May 15, Regular Price: $1,495.00

Overview:
Course "FDA Scrutiny of Promotion and Advertising Practices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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.
Agenda:

Day 1 Schedule

8:30 AM - 9:00 AM: Registration
9:00 AM - 10:30 AM
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
10:30 AM - 12:00 PM
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

12:00 PM - 1:00 PM Lunch
1:00 PM - 2:30 PM
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

2:30 PM - 2:45 PM Break
2:45 PM - 4:30 PM

Fair and balanced disclosure
Social media
Direct to Consumer Advertising

Hypothetical Workshop

Day 2 Schedule

9:00 AM - 10:30 AM
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

10:30 AM - 12:00 PM
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

12:00 PM - 1:00 PM Lunch
1:00 PM - 2:30 PM
Lecture 3:
Off label use - practices and policy
FDA Warning Letters
2:30 PM - 2:45 PM Break
2:45 PM - 4:30 PM
Lecture 4:
Practice of medicine exemption
Custom Device promotion
(Group Hypothetical)
Corporate management responsibility
Speaker:
Casper Uldriks
ex-FDA Expert and former Associate Center Director of 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.

Credits Available

Course "FDA Scrutiny of Promotion and Advertising Practices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

More Seminar Information

Global Compliance Panel
Summary	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.
Delivery Method	Seminar
Who Should Attend	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