Publications
Publications
- August 2008 (Revised September 2008)
- HBS Case Collection
The Flaxil Label (A)
Abstract
This case focuses on the 2001 negotiation between Mytex Pharmaceuticals and the U.S. Food and Drug Administration (FDA). The outcome of the negotiation would determine the new label for Mytex's blockbuster drug for arthritis, Flaxil. The negotiation is quite qualitative and differs from the typical price negotiation with which students are familiar. However, at stake was $500 million in Flaxil sales and the safety of millions of patients. The (A) case presents the perspective of Mytex and the FDA on new data suggesting the Flaxil may have a side effect.
Keywords
Governing Rules, Regulations, and Reforms; Health Disorders; Product Launch; Negotiation Process; Business and Government Relations; Safety; Pharmaceutical Industry
Citation
Barron, Greg M. "The Flaxil Label (A)." Harvard Business School Case 909-001, August 2008. (Revised September 2008.)