Case Detail

Case Summary

Reintroduce Thalidomide? (A)

Case Number: 5-104-003(A), Year Published: 2006

HBS Number: KEL058

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Authors: ; Jason Hermitage; Shail Thaker; Justin Heinze

Key Concepts

Thalidomide, Healthcare, Pharmaceuticals, Patient Advocacy, Non-Government Organizations, Global

Abstract

In the 1960s, Thalidomide, a popular new drug considered to be safe and effective, was revealed to cause severe nerve damage and birth defects in new-born infants, prompting health officials to ban the use of the drug and tighten overall restrictions on new drugs and drug use. Twenty years later, after recognizing the positive effects of thalidomide when treating patients with leprosy and its potential role in treatment of certain types of cancer and cases of HIV/AIDS, the Celgene Corporation would be forced to contend with stringent FDA regulations, liability concerns, public skepticism, and poor mass media portrayal in order to secure the drug’s approval.

Learning Objectives

After students have analyzed the (A) case they should be able to:

  • Understand the nature of regulatory challenges, including the issues involved, how these issues relate to market challenges, and the institutional environment that generates policy
  • Assess the impact of regulation-related corporate decisions on parties such as the company, specific regulatory bodies, target markets, and other interests
  • Develop a comprehensive understanding of how to frame an integrated strategy that addresses market and nonmarket challenges simultaneously
  • Number of Pages: 16

    Extended Case Information

    Teaching Areas: Biotechnology, Management, Manufacturing, Strategy

    Teaching Note Available: Yes

    Geographic: United States

    Industry: Pharmaceuticals

    Organization Name: Celgene

    Organization Department: Management

    Organization Size: Large

    Year of Case: 1995