Within recent years the effect of the First Amendment on FDA-controlled speech has drastically changed. Courts have stated standards for what FDA can do in controlling speech in advertisements. The difficult question is predicting the practical impact of these court decisions. FDA still has enormous authority to control speech and labeling. In this presentation we discuss the balance between FDA control of indications versus court restrictions on FDA control of speech.
This audio conference covers:
- Changes in court interpretation allowing constitutional protection for commercial speech
- What the Supreme Court has said about how this affects FDA control of advertising
- FDA reaction
- How this plays out in cases brought under Fraud and Abuse Laws
About the speaker:
Robert Klepinski is an Officer with Fredrikson & Byron and practices in the Food and Drug Administration, Health Care Fraud & Compliance and Intellectual Property service areas. He is also recognized as one of the leading FDA compliance attorneys. He counsels pharmaceutical, medical device, biotech, food and nutritional supplement companies on FDA policy. Previously, he served as a regulatory attorney for Medtronic. While there, he set the legal strategy for FDA compliance, including advertising and promotion, quality systems, regulatory and clinical.
Robert frequently speaks at local and national trade associations on FDA policy. He has been an adjunct professor at the University of Minnesota Law School and a guest lecturer at other law schools, including Northwestern University, Hamline University and William Mitchell College of Law. He is an adjunct professor at St. Thomas University Graduate School of Engineering and its MBA program.
Who should attend?
- Regulatory Affairs
- Marketing
- Legal Counsel
- Management
This audio conference is classified as General Interest.