title: Pharmaceutical innovation in the 21st century: new drug approvals in the first decade, 2000-2009.
abstract: The first decade of the 21st century was a challenging period for the pharma sector and could prove to be a turning point in the evolution of the industry. We examine drug development performance metrics for new product approvals during 2000-2009 and compare them with those of the prior two decades. The results indicate that, whereas total approvals are currently at a 25-year low, the percentage of priority products is nearly 50% of the total--a 30-year high. Following enactment of the Prescription Drug Use Fee Act of 1992 (PDUFA), the mean duration of the approval phases of drug development declined by more than 1 year over the 30-year period--to a low of 1.2 years in 2005-2009--whereas the duration of the clinical phases increased. The longer clinical phases were due, in part, to a greater number of approved central nervous system (CNS) and antineoplastic agents, two therapeutic classes with relatively long average development times (8.1 and 6.9 years, respectively). The results provide the underpinnings of a fundamental shift in the structure of the research-based industry.
authors.affiliation: Tufts Center for the Study of Drug Development, Tufts University, Boston, Massachusetts, USA. kenneth.kaitin@tufts.edu
authors.forename: K I
authors.initials: KI
authors.lastname: Kaitin
authors.forename: J A
authors.initials: JA
authors.lastname: DiMasi
mesh_terms: D017277:Drug Approval / Q000706:statistics & numerical data*; D055808:Drug Discovery; D004345:Drug Industry / Q000639:trends*; D007880:Legislation, Drug; D009965:Orphan Drug Production; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration