Roche and Fuzeon (T-20): Managing Access After Approval (B)

Roche faced a dilemma because it had developed the first drug that could treat patients with multidrug-resistant HIV and, as a result, could prolong the lives of HIV patients whose illness had progressed the most significantly. The problem was that the research needed for an application for approval had not yet reached the level of rigor in evidence that Roche followed and that medical approval authorities such as the FDA and the CHMP required. However, Roche was already under pressure to provide the drug to patients because it was promising, and its use would be restricted to patients who had no other treatment available. Public protests against perceived delays in releasing the drug collided with Roche’s commitment to rigor, creating a significant crisis for the company.

The case is intended for teaching crisis management. The protagonist company has never before encountered such a contentious drug development and approval process and is now facing highly visible protests with significant press coverage, while the scientific process and production constraints suggest that the regular, slower process is preferable.
In Case B, the company has decided to broaden the release of the drug and is now facing additional pressures because demand is very high, and pricing that would match the expensive production process would also be very high.