2-Day Seminar: FDA Scrutiny of Promotion & Advertising Practices (Baltimore, United States – June 27-28, 2019) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “FDA
Scrutiny of Promotion and Advertising Practices”
conference has
been added to ResearchAndMarkets.com’s offering.

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.

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
unwelcome 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.

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 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

Agenda

Day 1 Schedule

8:30 AM – 9:00 AM: Registration

Lecture 1: FDA legal authority – 9:00 AM – 10:30 AM

  • 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 – 10:30
AM – 12:00 PM

  • 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

Lecture 3: Supreme Court / commercial free speech – 1:00 PM –
2:30 PM

  • 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

Fair and balanced disclosure – 2:45 PM – 4:30 PM

  • Social media
  • Direct to Consumer Advertising
  • Hypothetical Workshop

Day 2 Schedule

Lecture 1 – 9:00 AM – 10:30 AM

  • 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 – 10:30 AM – 12:00 PM

  • 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

Lecture 3 – 1:00 PM – 2:30 PM

  • Off label use – practices and policy
  • FDA Warning Letters

2:30 PM – 2:45 PM Break

Lecture 4 – 2:45 PM – 4:30 PM

  • Practice of medicine exemption
  • Custom Device promotion
  • (Group Hypothetical)
  • Corporate management responsibility

For more information about this conference visit https://www.researchandmarkets.com/r/wnwnol

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
[email protected]
For
E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call
1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related
Topics: Pharmaceuticals,
Medical
Devices

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