Social Media for FDA Regulated Industry: Navigating the Web of Rules and Guidance

Why Should You Attend:

Since the advent of the internet in the 1990s, the FDA has struggled to craft a coherent set of rules and guidelines to govern manufacturer participation in and use of electronic media. With uncertainty in the rules and the collision between regulation and constitutional limitations, the industry has taken the lead in attempting to craft the path forward. With 21st century technology reshaping the marketplace and social media dominating the new information age, industry participation is unavoidable. Despite the uncertainty in rules, state and federal civil and criminal enforcement threatens on one side and private litigation looms on the other. Charting a path through the regulatory thicket requires vigilant focus. With recent guidance from the FDA, now is the time to ensure you know the rules and have the policies and procedures in place to avoid the disruption of enforcement or litigation.

This webinar will provide an overview of FDA and FTC regulations of social media. It will discuss the recent guidance on the use of social media for FDA regulated industry and how to comply with these regulations.

Areas Covered in the Webinar:

• Brief overview of FDA and FTC oversight of Social Media for FDA regulated industry.
• Analysis and outline of the recent draft guidance, including Interactive Promotional Media, Unsolicited Requests and Advertising and Promotional Labeling.
• Synthesis of the significant constitutional hurdles to FDA’s regulation of Social Media, including significant Due Process and First Amendment issues.

• What are you responsible for and what FDA and FTC expect from manufacturers and distributors.
• Drafting and Implementing workable policies and procedures.
• Substantiation of claims.

• Examination of recent enforcement actions.
• A look at the litigation horizon: Preemption vs Parallel claims, negligence per se and other evolving theories.
• A look at the penalty side of enforcement?

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Marketing, Promotion and Advertising for FDA regulated industry
• Regulatory affairs
• Pharmacovigilance
• Labeling
• Documentation

Instructor Profile:

Michael Walsh, is a partner in the Dallas office of Strasburger & Price, and leads the firm’s Food and Drug Law Industry Team and is a regular contributor to the firm’s Food and Drug Law Blog. Mr. Walsh is licensed to practice in Texas and New York and devotes his practice to representing clients in complex litigation matters and focuses most of his practice on FDA regulated industries and issues related to labeling and compliance. He is a member of the Drug Device and Biotech Committee of the Federation of Defense and Corporate Counsel, DRI Drug and Device Committee, ABA Section of Litigation, and the Association of Food and Drug Officials. He is a frequent writer and speaker on FDA issues and issues related to marketing, promotion and litigation for FDA regulated industry.

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