Hoffmann-la-Roche and Accutane Controversy
Stakeholder Analysis
Team 1:
Whitney Lettin
Yuliya Kaliada
Yafei Wang
Savan Mandalia
Executive Summary
Embracing the ideals of CSR has become imperative for Roche in order to maintain its competitive advantage. The controversy around Accutane, one of the company’s best performing and most powerful drugs, only reinforces this fact. When Accutane appeared on the market, it became a “miracle drug” for those who were suffering from the most severe types of acne. At the same time its powerful side effects, including teratogenicity, clearly outweighed the “miracle effect” for many patients. Roche’s failure to implement an effective risk management program (RMP) concurrently with the release of the drug triggered frequent pregnancy exposures, severely deformed babies born as a result and following lawsuits. Our analysis shows that Roche wasn’t proactive enough in managing its stakeholder relationships – namely, with the FDA, its main customers (doctors and patients) and various pressure groups. Had the company been more responsive to their needs, it probably wouldn’t have had to eventually remove Accutane from the U.S. market. We believe that Roche needs to make pregnancy prevention its #1 priority when disbursing Accutane in other countries (and if it is ever released in the United States again). We recommend creating a comprehensive RMP with effective compliance enforcement mechanisms attached to it, such as requiring doctors to submit pictures and descriptions of the patients and to provide some proof of alternative treatment options having been exhausted; to not only communicate all side effects to each patient but also emphasize them with pictures and statistics; to prescribe alternative forms of birth control that are less prone to human error; and to only administer prescriptions to patients who are 18
