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Seminar Summary:

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. (see full course description)

 
 
 

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Training Course Syllabus:


Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices: 2-day In-person Seminar

Course Description:

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 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 OUTLINE:
DAY ONE (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

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 TWO (8:30 AM – 4:30 PM)

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

Seminar Summary:

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. (see full course description)

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