This webinar will provide an overview of regulations for the use of social media for promoting FDA regulated products. Attendees will learn how to comply with these regulations and avoid enforcement actions.
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.
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Analysis and outline of the recent draft guidance, including Interactive Promotional Media, Unsolicited Requests and Advertising and Promotional Labeling.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.
How to Comply:
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:
What is the law?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Analysis and outline of the recent draft guidance, including Interactive Promotional Media, Unsolicited Requests and Advertising and Promotional Labeling.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.
How to Comply:
- 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.
- What happens if you get it wrong?
- 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
Course Provider
Michael Walsh,
