General Director of Biogen Idec faces many difficult decisions about long-term drug for multiple sclerosis, which is headed by an early approval FDA. The first in a series devoted to the operational decisions due to drive early adoption. Sparks leaders to discuss the economic, legal and ethical responsibilities in several constituencies, and as a leader can lead the company to fulfill these responsibilities effectively, in a difficult situation. The decisions facing the company include how to maintain robust research on the effectiveness and safety of the drug, how to increase manufacturing capacity to meet anticipated demand, and how to protect the insurer reimbursement. All these problems occur on the background of accelerating the approval process, the uncertainty that the FDA will ultimately decide, and whether the company really needs to hold an early statement. "Hide
by Joshua D. Margolis, Thomas J. DeLong Source: Harvard Business School 17 pages. Publication Date: November 14, 2007. Prod. #: 408025-PDF-ENG