FDA and Social Media - How to Promote your Products Using Web 2.0 in Compliance with FDA and FTC Laws and Regulations

Why Should You Attend:

What are the laws and regulations that FDA and FTC regulated companies should comply with when using social media channels, i.e., Web 2.0, to promote their products? How do they assure compliance in light of the Food Drug & Cosmetic Act among other laws and regulations?

This webinar will discuss ways manufacturers of life science products are currently using social media in light of applicable laws and regulations, and recent FDA enforcement actions. Practical real-world examples and experiences will be offered. This webinar will also cover new guidance from FDA regarding how to respond to unsolicited requests for off-label information in social media outlets. The presenter will focus on strategies and tactics that companies can employ to lessen regulatory risk.

Areas Covered in the Seminar:

PROMOTION AND ADVERTISING

• How do FDA and FTC regulations govern social media?
• How is Web 2.0 advertising and promotion different than more standard channels like print, TV and radio?
• What is the current regulatory environment like?
• What is government concerned about?
• Are the claims you are making about your products in compliance with FDA and FTC regulations?
• Are you misbranding and/or adulterating your products because of the claims you are making or the manner you are making them?
• Are you meeting the FDA guidance, “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices”?

FDA COMPLIANCE AND ENFORCEMENT

• If you are using social media improperly, then you are probably violating FDA and/or FTC laws and regulations. How do you go about remedying such issues?
• What is your exposure? The government does not care if “everyone else is doing it.” If you are violating the law, sooner or later, FDA will come knocking.
• How the government finds out about your conduct (competitors, social media, company website, distributor conduct, etc.)

Who will Benefit:

• CEOs and Executive Management
• Regulatory Affairs
• Marketing
• Clinical
• Legal
• R&D
• Quality Assurance
• Content Writers and Documentation

Instructor Profile:

Mark Gardner, M.B.A., J.D., is an attorney at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, drug, biotech, dietary supplement and food industries. His practice focuses on FDA regulation, health care fraud and compliance, design and implementation of regulatory compliance programs, promotional review, FDA enforcement actions and aggregate spend.

Mark is uniquely qualified to understand and address the needs of clients in a highly-regulated field. He brings special insight, experience and in-depth knowledge of the practical problems encountered by his clients in attempting to clinically study, obtain approval for and market medical devices, drugs and dietary supplements.

Prior to his legal career, he worked in product management and sales for three medical device companies over a 10-year span where he focused on commercializing and developing products used for surgical, wound healing, and diagnostic applications.

Mark is an Adjunct Professor at Hamline University School of Law where he teaches FDA law. He currently serves as a Co-Chair for LifeScience Alley's Regulatory Special Interest Group. He is Chairman for the Minnesota State Bar Association Food, Drug and Device Law Section. He also serves as a Steering Committee Member for the Minnesota Medical Device Alliance. He is a member of the Medtech Resource Alliance. Mark speaks, writes and is quoted regarding issues that impact FDA regulated products.

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