FDA and Management Responsibility for Social Media Use
Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He started with the FDA as a field investigator, worked in the Commissioner’s Office for Congressional Oversight Investigations and was the associate Center Director for Regulatory Guidance and Government Operations in 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 practical value. He understands how the FDA thinks, operates, and where it is headed. He is licensed to practice law in Massachusetts and the District of Columbia.
The use or participation in social media can lead to some surprising outcomes with the FDA. The sweeping statutory definition of “labeling” covers the use of information that appears in social media. There are several platforms that can present information either by you or a third-party, all of which can become an action by the FDA against the management’s actions or inactions. Firms should develop and implement self-audits to make sure you are not blithely jumping into social media. There are responsibilities. One wrinkle to management’s concerns should be the use of social media by employees.
FDA regulates how firms advertise and promote their products in social media and create a regulatory risk of enforcement action when a firm’s step over FDA’s somewhat mysterious advertising and promotion boundaries. What you or someone else says about your product, whether true, false, or misleading, becomes a target for FDA’s legal hammer. FDA can levy fines, issue Warning Letters, and even an injunction or prosecution end up creating a corporate crisis and confusing your customers or driving them away.
- Social Media Platforms as Labeling
- False and Misleading Labeling
- FDA and FTC Legal Declarations
- Case Studies
- Corporate Management’s Legal Responsibility and Liability
Course Level - Basic/Fundamental
Who Should Attend
- Regulatory Affairs Director
- Marketing Director
- Quality Assurance Manager
- Medical Director
- Operations Finance Managers
- Complaint Department Manager
Why Should You Attend
FDA’s regulation of social media operates with a moving target. What is OK or not OK remains vague, perhaps purposely so. Your firm’s executive management ends up with the legal responsibility for what happened. A pitfall lurks in areas where you fail to take the initiative to check what is being said about your products and how you manage that dynamic of making claims. A failure to include an audit of social media platforms may end up surprising you with an unwelcomed letter from the FDA that explains how you are in violation of FDA law. No one, especially your senior management, wants to be facing a problem with the FDA based on your failure to pre-emptively act on claims made in social media. You need an assertive defense.