Responsibility for Off-label Claims in Social Media

Duration: 60 Minutes
FDA regulates how firms advertise and promote their products in social media and creates a regulatory risk of enforcement action when 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.
Off-label Claims in Social Media
Instructor: Casper E Uldriks
Product ID: 508663
Objectives of the Presentation
  • Social Media Platforms as Labeling
  • False and Misleading Labeling
  • FDA and FTC Legal Declarations
  • Case Studies
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. All social media platforms provide common ways to cross FDA's legal boundaries for "misbranding" your product, whether knowingly or unknowingly. In the end, 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.

Areas Covered
  • Scope of Labeling and Claims
  • Constitutional Protection of Commercial Free Speech
  • Social Media Use
  • Direct-to-Consumer Intended Use Problems
  • Corporate Management's Legal Responsibility and Liability
Who will Benefit
  • Marketing managers
  • Regulatory affairs managers
  • In-house legal counsel
  • Third-party consultants
  • Own Label distributors
  • International trade managers
  • Product specification developers
  • Corporate web managers
  • International trade managers (imports and exports)
  • Marketing and public relations consultants
  • FDA Quality Assurance (QA) consultants
$249
Recorded Session for one participant
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Instructor Profile:
Mr. Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.
Bar Admissions: Massachusetts, 1986 and District of Columbia, 2011
Education: Suffolk University Law School, Boston, Massachusetts, 1986.
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