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Device
Advertising and the First Amendment: Your Rights
Robert
J. Klepinski
Fredrikson & Byron
Purchase
recording US$199
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Purchase
recording of this audio conference
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 will discuss the balance between FDA control
of indications versus court restrictions on FDA control of speech.
This audio
conference will address:
- 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
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