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Validity : 29th May'23 to 08th Jun'23
The FDA treats information on social media as labeling. What appears on social media can be attributed to the manufacturer as labeling, regardless of the source. Social media blends individual and commercial free speech. The overlap creates confusion regarding who said what. The FDA and firms must heed the Constitutional boundaries of “commercial free speech.” A firm’s speech must be true and not misleading.
Social media information functions as direct-to-consumer communication for individuals and manufacturers. What information is conveyed to the consumer by a firm must be fair and balanced. That’s not true for an individual’s communication. The FDA’s actions concerning social media communication will be discussed. Firms have a new regulatory responsibility concerning product claims when presented via the public’s use and a firm’s use of social media. Some basic first steps in that regard will be presented.
The FDA’s regulation of social media operates with a moving target. What is acceptable or not acceptable remains vague. All social media platforms provide common ways to cross the FDA’s legal boundary for “misbranding” your product, whether knowingly or unknowingly. Anyone can post information about your product. This uncontrollable source of information can leave a firm chasing false and misleading claims. How does a firm manage what anyone says about their products? The FDA can hold manufacturers responsible for what someone else posts. That means firms have a new responsibility and need a strategy to avoid the FDA’s unforgiving regulatory eye. In the end, your firm’s executive management ends up with the legal responsibility to avoid misbranding problems with social media.
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” 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 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. 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. Professional credentials: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.