Off-label promotion is a perennial focus for FDA enforcement actions, and an area of chronic concern for pharmaceutical and medical device companies. The dividing line between legitimate scientific exchange of information and off-label promotion can, at times, be somewhat blurry. It is vitally important for everyone on your team to know what can and cannot be said in the name of product promotion, and for your company to have in place a strategy to stay compliant.

In this audio conference, our speaker reviews the regulations concerning product promotion in the life sciences, sharing experience and insight on some of the red-flag areas likely to attract unwanted attention from FDA. The presentation looks at the Good Reprint Practices guidance, and what it does and does not say about sharing off-label information. It also discusses the role of medical affairs and the medical science liaison, and reviews factors to consider when determining what is and is not acceptable promotional activity.

This audio conference covers:

• Recent FDA enforcement actions, and key takeaways for life sciences companies
• Promotional red flags you must find and remove from your marketing materials
• Scientific exchange vs. off-label promotion – key factors to consider
• What role should Medical Affairs and MSLs play?
• Key areas likely to attract FDA attention
• Provisions of the Good Reprint Practices guidance

About the speaker:

Alan Minskis a partner and practice leader of the Food & Drug Practice Team of Arnall Golden Gregory LLP. He advises pharmaceutical and medical device companies on all legal and regulatory matters relating to the FDA and DEA. He counsels, speaks and writes on a wide variety of FDA-related issues, including regulatory strategy and lifecycle management, FDA enforcement, market exclusivity, FDA inspections, corporate compliance, promotion and advertising, product liability, imports and exports, and clinical trial issues. He also conducts in-house training on a wide variety of FDA and fraud and abuse-related topics.

Alan serves on several editorial boards, has been published in numerous professional journals, and is a frequent speaker at industry events. He earned his J.D. from Georgetown University.

Who should attend?

• Sales and Business Development
• Marketing
• Regulatory Affairs
• Legal Counsel