The United States Food and Drug Administration’s (FDA) approval of interferon beta-1b (brand name Betaseron ®) made it the first multiple sclerosis (MS) treatment to get FDA approval in 25 years. Betaseron was developed by Berlex Laboratories, a U.S. unit of Schering AG, the German pharmaceutical company. Berlex handled the clinical development, trials, and marketing of the drug, while Chiron Corporation, a biotechnology firm based in California, manufactured it. The groundbreaking approval of Betaseron represented not only a great opportunity for Berlex but a dilemma. Supplies were insufficient to meet initial demand, and shortages were forecast for three years. With insufficient supplies and staggering development costs, how would Berlex allocate and price the drug?

The Challenge of Multiple Sclerosis

MS is a disease of the central nervous system that interferes with the brain’s ability to control functions such as seeing, walking, and talking. The nerve fibers in the brain and spinal cord are surrounded by myelin, a fatty substance that protects the nerve fibers in the same way that insulation protects electrical wires. When the myelin insulation becomes damaged, the ability of the central nervous system to transmit nerve impulses to and from the brain becomes impaired. With MS, there are sclerosed (i.e., scarred or hardened) areas in multiple parts of the brain and spinal cord when the immune system mistakenly attacks the myelin sheath.

 

QUESTION IS: IN YOUR OWN WORD, WHAT  IS BETASERON'S DILEMMA?

Answer rating: 100% (QA)

The following are the main ethical CSR issues raised in this case 1 Because stringent quality contro... View the full answer