The Risks Embedded in Using Social Media for Product Promotion
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He served as an investigator, senior manager in the Office of Compliance at the Center for Devices and Radiological Health (CDRH) and as the Associate Center Director for Regulatory Guidance and Government Operations at CDRH. He developed enforcement actions for FDA and participated in the implementation of new statutory requirements and policies. He also served as a public health specialist in the House of Representatives Subcommittee on Small Business. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He is licensed to practice law in the District of Columbia and the Commonwealth of Massachusetts.
What a firm can say in social media and what an individual can say, are two different worlds, but it is easy to jump unknowingly from the individual to the corporate world of what is legally acceptable to FDA. Firms need to extrapolate corporate boundaries for how they can use and not use social media. What a firm says and how firms deliver a message are equally laden with risk. And ripe for FDA’S administrative and regulatory actions. To further complicate the matter, the boundaries for what a firm can and cannot say are not uniform. You need to understand FDA’s regulatory approach to avoid the marketing 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.
- 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
Course Level - Basic
Who Should Attend
- Regulatory Affairs Director
- Marketing Director
- Quality Assurance Manager
- Medical Director
- Operations Finance Managers
- Complaint Department Manager
Why Should You Attend
The use of social media provides an easy platform for reaching new and current customers. Social media formats exponentially convey a message that multiples its message delivery, regardless of whether the message is true, false, misleading. Once the message starts, you cannot stop it, only try and correct it. FDA holds a firm accountable for what information it conveys or information leaves out. FDA’s regulatory hammer may blindside you because you do not know what has spun out of your control. This is a comparatively new area for labelling enforcement that thrives in a grey area of FDA regulation. Firms must develop and implement a program with specific procedures to stay within regulatory boundaries. What a firm can say and what an individual can say, are two different worlds, but it is easy to jump unknowingly from the individual to the corporate world.
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 the 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?”
FDA regulates how firms promote their products on social media. It creates a regulatory risk for enforcement action when firms step over FDA’s somewhat mysterious legal boundaries for advertising and promotion. What you or someone else says about your product, whether true, false or misleading, can become a target for FDA’s legal hammer. FDA can levy fines, issue Warning Letters, or worse. Such a corporate blunder confuses your customers and may drive them away. Corporate management is accountable and ends up paying an avoidable monetary expense and smear on its corporate face.