Promotion and Advertising Practices - FDA Scrutiny 2019

By GlobalCompliancePanel (other events)

Thu, Jan 17 2019 9:00 AM Fri, Jan 18 2019 6:00 PM


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.

Who Will Benefit:

Regulatory Managers
In-house Legal Counsel and Contract Specialists
3rd party consultants
Venture Capitalists
Business Acquisition Executives
Owners of New or Developing Firms
Own label distributors
International Trade Managers
Product specification developers


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
Sales force
What is "off-label?"
Practice of Medicine exemption
Drugs authority
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



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
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



Casper Uldriks

ex-FDA Expert and former Associate Center Director of CDRH

Casper (Cap) Uldriks owns Encore Insight LLC, which provides consulting services on FDA Law. He 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 as 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.


Location:  SFO, CA Date: January 17th &18th, 2019 and Time: 9:00 AM to 6:00 PM

Venue:  Hilton San Francisco Airport Bayfront 600 Airport Blvd, Burlingame, CA 94010



Register for 1 attendees Price: $2,000.00

Register for 5 attendees Price: $10,000.00

Register for 10 attendees Price: $20,000.00


Sponsorship Program benefits for seminar

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