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Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices

  • Training

  • Compliance Online
  • ID: 5626605
Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the regulators that demands, in turn, that industry be keenly aware of the legal and regulatory duties, as well as key recent trends in enforcement activities by the Federal Government. This course will explore in detail what FDA requires of drug and device firms as well as recent current hot buttons in FDA enforcement activity for the advertising arena.

What’s at stake if your advertising and promotional efforts violate the law? Colossal fines - the latest was $3 Billion; criminal liability, including even prison time; and huge disruption in operations while dealing with federal probes into illegal marketing.

Learning Objectives:

Key goals of the conference will include learning:
  • The basics of FDA law and regulations governing advertising and promotion, as well as sister agencies such as the Federal Trade Commission, which shares jurisdiction with the FDA on certain regulated products (e.g., OTC drugs).
  • The distinctions between labels, labeling, and advertising and how that impacts FDA's powers, and
  • How to properly position Direct-to-Consumer (DTC) promotions
  • The Dos and Don'ts of promoting products on the internet, including social media sites such as Facebook and Twitter
  • The perils of off-label promotion, including criminal and civil actions that have led to multi-billion dollar settlements by regulated drug companies
  • Whether the First Amendment provides any insulation for truthful statements regarding regulated products;
  • When disseminating medical educational materials crosses the line into improper promotion; and
  • Key considerations on how to implement appropriate procedures and controls in your company to minimize the potential for regulatory action by the FDA or the FTC relative to promotion and advertising.

Course Content

Day 01 (10:00 AM to 5:00 PM EDT)

I. Understanding the Basics
  • Who Has Jurisdiction
  • Drugs & Biologics
  • Rx Drug Advertising
  • OTC Drug Advertising
  • Devices
  • Restricted
  • all other
  • Labeling vs. Advertising
  • Basic drug rules
  • Fair balance
  • Device rules
  • Intended use deviations
  • DTC advertising
  • Print
  • TV
  • Comparative Claims
  • Standard to support
  • Push to pursue CER
  • Detailing and Sampling
  • Is there still a future?
  • What can be said?
  • Danger of “custom” pieces
  • How FDA learns of violations
  • Keep your house clean or your competitors will rat you out
II. Scientific Exchange
  • Guidances on Dissemination of Scientific Information
  • Risks involved in Off-Label Statements
  • Procedural Requirements and Unsolicited Requests for Information
III. First Amendment
  • Understanding “Commercial Speech” Doctrine
  • FDA and the Regulation of Advertising
IV. Websites & Social Media
  • FDA Policies on the Internet
  • Recent FDA Enforcement Activities
  • How to Handle at the Company Levels
Day 02 (10:00 AM to 5:00 PM EDT)
V. Enforcement Trends
  • FDA Hot Buttons
  • Understating risk
  • Overstating effectiveness
  • FTC
  • POM Wonderful and substantiation
  • Private Litigation - Understanding
  • Lanham Act
  • State Unfair Competition
VI. False Claims Act and Criminal Liability
  • Review of Key Settlements
  • “Responsible Corporate Official” Liability
VII. Handling at the Company Level
  • Compliance Programs
  • Internal processes

Course Provider

  • Alexander Zachos
  • Alexander Zachos,
    Takeda Pharmaceuticals

    Alex has been in Regulatory Affairs for 11 years, 10 of which he has specialized in Advertising and Promotion. He presently serves as Director, US Advertising & Promotion Regulatory with Takeda Pharmaceuticals U.S.A., Inc., supporting the Neuroscience & Vaccines Business Unit. Alex also serves as the Regulatory A&P Chair for Takeda’s Digital Catalyst Team and is a Board Member on Takeda’s SocialMedia.org Team. In addition, he has been a Faculty Speaker at several Industry Conferences. Alex earned his J.D. from Mercer University School of Law in Georgia, where he focused in the areas of Corporate and Healthcare Law. Alex also has a B.A. in Political Science from Huntingdon College.

Who Should Attend

Senior executives, directors, managers, and those who have responsibility for implementing advertising and promotional activities, as well as those that have key collateral roles in reviewing advertising for drug and device firms, including officials from these areas within regulated companies:

  • Sales
  • Marketing
  • Medical Affairs
  • Legal
  • Regulatory
  • Compliance