Off-label Promotion in Social Media - Broken Boundaries

Why Should You Attend:

The use of social media provides a platform for communication that exponentially conveys a message, any message, whether it is true, false or misleading. FDA holds industry accountable for what information is conveyed or not conveyed, whether a firm knows about the posted social media information or not. This is a new area for labeling enforcement that thrives in a grey area. Likewise, firms must develop a program to address the regulatory boundaries of what they can and cannot say. You need to extrapolate boundaries base on FDA’S administrative and regulatory actions. To further complicate the matter, the boundaries for what you can and cannot say are not uniform. What you can say in one part of the country is not permitted in other parts of the country. You need to understand FDA’s regulatory approach to avoid the lure that social media creates for illegal off-label use. This begs the question, “Is there legal off-label use?”

Regulatory affairs departments and marketing departments need to operate under a strongly supported corporate policy for managing social media. Actually, a corporate policy affects all of the employees that work for a firm and can leave the firm accountable for what employees say on-line. You need to establish and follow well defined guidelines for yourself.

FDA’s regulation of Social media operates with a moving target. What is OK or not OK remains vague, perhaps purposely so. All social media platforms provide common ways to cross FDA’s legal boundaries, whether you do it knowingly or unknowingly. How you salvage your regulatory posture needs a clear corporate policy, procedures and effective implementation. As information increases with technology, FDA will need to analyze what works and what does not from a practical point of view. FDA has a weak legal history on this topic. Federal courts keep pushing back the Constitutionality of FDA’s enforcement actions. The problem is that no one can figure out a clear future for FDA and for themselves.

Areas Covered in the Webinar:

• Constitutional Protection of Commercial Free Speech
• Scope of Labeling
• FDA Policy and Enforcement
• Social Media Use
• Direct-to-Consumer Intended Use Problems
• Education Information Alternatives
• Overlapping Federal Laws
• Corporate Management’s Legal Responsibility and Liability

Who Will Benefit:

• Regulatory Affairs Director
• Marketing Director
• Quality Assurance Manager
• Medical Director
• Operations Finance Managers
• Complaint Department Manager
• Manufacturers of food, drugs, cosmetics, devices and biologics
• Clinical Study Sponsors and Clinical Investigator
• 3rd Party Medical Consultants
• 3rd Party Webmasters
• Device Specification Developers
• FDA Drug and Device Consultants

Casper Uldriks
Former Associate Center Director, CDRH

Casper Uldriks, through his firm Encore Insight LLC, brings over 32 years of experience with the FDA. He specialized in FDA’s medical device program as a field investigator, 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. His comments are candid, straightforward and of practical value. Mr. Uldriks 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. His professional credentials include: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.

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