Center for Drug Evaluation and Research growing crisis around HIV testing and treatment and an inter-agency dispute between officials from the former Bureau of Drugs and officials from the former Bureau of Biologics over whether to approve Genentech's Activase (tissue plasminogen activator) led to the split. In its original form, CDER was composed of six offices: Management, Compliance, Drug Standards, Drug Evaluation I, Drug Evaluation II, Epidemiology and Biostatistics, and Research Resources. The Division of Antiviral Products was added in 1989 under Drug Evaluation II due to the large amount of drugs proposed for treating AIDS. The Office of Generic Drugs was also formed. In 2002,
Orphan drug incentives, such as an extended period of exclusivity, a time during which that company is the only one allowed to market the orphan drug—all intended to encourage the development of those drugs which might otherwise lack a sufficient profit motive and market to attract companies' research budgets and personnel. An orphan drug is a pharmaceutical agent which has been developed to treat a rare medical condition, the condition itself being referred to as a rare disease. A rare disease, also referred to as an "orphan disease", is any disease which affects a small percentage of the population. Most rare diseases