FDA’s regulation of social media operates with a moving target. The scope of interest covers more than firms know or appreciate. What is OK or not OK with FDA remains vague, perhaps purposely so. FDA’s ambitious regulation has no boundaries. FDA reaches into areas that may cause disbelief and you think, “Really?” All social media platforms provide common ways to cross FDA’s legal boundaries for “misbranding” your product, whether knowingly or unknowingly, and cause it to be illegal.  In the end, your firm’s executive management ends up with the legal responsibility for what happened. Pitfalls lurk 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 unwelcome 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.

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.

Areas Covered:-

• Social Media Platforms as Labeling
• False and Misleading Labeling
• FDA and FTC Legal Declarations
• Case Studies
• Scope of Labeling and Claims 
• Constitutional Protection of Commercial Free Speech 
• Social Media Use
• Dual Federal Legal Liability
• Corporate Management’s Legal Responsibility and Liability

Who Will Benefit?

This 60-minute online course is intended for professionals in the Pharmaceutical and Biopharmaceutical Industry. Although not presently stated in the draft, the same guide could be used by FDA Regulated Industries personnel.

• Regulatory Affairs Director
• Marketing Director
• Quality Assurance Manager
• Operations Managers
• Complaint Department Manager
• Human Resources Training Program Managers