FDLI April 2001

44^th Annual Educational Conference FDL! April 18-19, 2001 Washington, DC

A DRUG BY ANY OTHER NAME: THE REGULATORY PERILS AND PITFALLS OF DRUG NOMENCLATURE

Naming Consultants

Session Chair:

Geoffrey M. Levitt, Partner, Venable, Baetjer, Howard & Civiletti, LLP

Participants:

James L. Dettore, President and CEO of Brand Institute, Inc., a pharmaceutical branding, biotechnology branding, and consumer branding consultancy firm.

Jerry Phillips, Associate Director for Medication Error Prevention, Office of Premarketing Drug Risk Assessment, CDER/FDA

Cynthia B. Summerfield, Senior Director of Trademarks, Pharmacia Corporation

The process of selecting a trade name for a new drug, and of maintaining that name under FDA’s regulatory scrutiny – both pre-marketing and post-marketing – has changed radically in the past two to three years. This panel will examine the current pharmaceutical naming situation at FDA, with an emphasis on practical issues that drug sponsors should bear in mind as they go about the complex, expensive, and increasingly risky business of coming up with new trade names.

The session will examine such issues as:

• FDA’s expanding role in pharmaceutical naming. What is driving it? How has the agency re-organized itself to this task? Where is it headed?
• What does the FDA look for in deciding when a drug trade name is “false or misleading” or “confusing”?
• What are the most (and least) productive ways to approach FDA on pharmaceuticl naming issues? What has worked and what hasn’t?
• How do trademark law considerations intersect with regulatory considerations in the nomenclature process?

How does all this get balanced with effectively selling the drug?
Naming Consultants