FDA Scrutiny of Promotion and Advertising Practices
Course
In San Francisco (USA)
*Indicative price
Original amount in USD:
$ 1,295
Description
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Type
Intensive workshop
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Level
Advanced
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Location
San francisco (USA)
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Class hours
9h
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Duration
2 Quarters
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Internship
Yes
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.
Important information
Documents
- FDA Scrutiny of Promotion and Advertising Practices.pdf
Government funding available
Facilities
Location
Start date
Start date
About this course
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.
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
Reviews
Subjects
- Cognitive Psychology
- Advertising
- Social Media
- Psychology
- Regulations
- Options
- Media
- Marketing
- Business
- Marketing manager
Teachers and trainers (1)
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. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He underst
Course programme
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
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
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
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
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
Additional information
FDA Scrutiny of Promotion and Advertising Practices
*Indicative price
Original amount in USD:
$ 1,295