This presentation is part of: L50-1 (1905) Regulation and Industrial Policy

Controversy Surrounds Cerezyme and Biotechnology

Patricia Griffin, BS, RN1, Magdalena Falcon-Law, BS, RN1, Iris Perales, BS1, and Vincent Maher, JD, MA, MS2. (1) Department of Health Care Programs, Iona College, c/o Maher, Hagan School of Business, Iona College, 715 North Avenue, New Rochelle, NY 10801, (2) Health Care Programs, Iona College, 715 North Avenue, New Rochelle, NY 10801

Orphan drugs have enjoyed product monopoly under the protection of U.S. legislation; in essence, pharmaceutical companies are awarded seven year exclusivity contracts as they specifically target “orphan” diseases. Recently, media attention focused on a rare disease that has one of the most costly treatments; namely, scrutiny was placed on the manufacturing and selling of Cerezyme, which is used to treat Gaucher disease. This drug generates huge profits although it treats only a small percentage of the population. This billion dollar industry has gained the attention of insurance companies, tax payers and the media. The astronomical price of the drug has allowed the manufacturer, Genzyme, to reap huge profits in a monopolized environment. Insurers and experts question whether the recommended doses of the medication are too high and allege that patients may do just as well on smaller doses. In addition, patients undergoing treatment are known by Genzyme, as the population is small, touching on privacy issues (Pollack, 2008).Current use of this medication has caused considerable debate as it is wondered if the field of biotechnology has had an unfair advantage; the manufacturers are protected from competition and are awarded considerable tax breaks for manufacturing this and other similar medications (Calabro, 2006). The pharmaceutical companies contend that a significant amount of money is allocated to the research and development of these drugs; however, after the initial investment how much does it really cost the pharmaceutical company? This paper will delve into these issues and essentially discuss how a company can charge so much for a medication that ultimately is the difference between life and death for some patients.