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. You will 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.
Why should you attend:
If you go "off label" with advertising and promotion, you become embroiled in FDA's advertising and promotion requirements. For devices, the law is weak and lacks legal clarity. For drugs, FDA's law and regulations are extensive and have violated Constitutional protections. Depending on your point of FDA's promotion and advertising requirements can help you or hurt you? There is an inherent conflict in interests. In any case, you need to identify practical criteria to make marketing decisions. That begs the question of whether or not marketing managers and regulatory affairs managers will even try to agree on an issue. FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. CDER has established a pervasive and expanding program. For example, policing social media has become a new regulatory responsibility. Bottom line, do you know when you are running afoul of FDA's requirements or are you guessing? It's become a brooding nightmare for you and consumers.
Areas Covered in the Session:
FDA's legal authority and Constitutional limitations
FDA requirements and exemptions
FDA guidance documents, such as for social media, direct -to-consumer advertising, message formatting and providing risk/benefit information
Casper Uldriks :Casper (Cap) Uldriks, through his firm "Encore Insight LLC," brings over 32 years of experience from the FDA. As an investigator, he was responsible for countless 483s, scores of Warning Letters, injunctions, individual seizures, mass seizures and was coined by industry as FDA's "Darth Vader." He inspected foods, drugs, methadone clinics and clinical investigators, but specialized in the FDA's medical device program. He served as a senior manager in the Office of Compliance and 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 for FDA. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA's domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.
Day 1 Schedule
FDA legal authority
FTC / mass media
DOJ / False Claims
FDA application of the FD&C statute and regulations
False and Misleading
Promotion and Advertising: scope of labeling
Definitions for "label" and "labeling"
Hard copy and electronic
What is "off-label"?
Practice of Medicine exemption
Supreme Court / commercial free speech
FDA organizational responsibility
Balanced disclosure of risk vs. benefit
Direct to Consumer Advertising
Day 2 Schedule
Direct to consumer advertising
Federal Trade Commission authority
Fair and balanced information
Context and format
Script versus message
False and misleading information
Statutory basis (21 U.S.C. 352(a))
Claims for safety and effectiveness
Sales for solicitation
Off label use
FDA Warning Letters
Corporate management responsibility
FDA - false and misleading
FTC - false advertising
DOJ - false claims
FDA Consultants and Legal Counsel