title: An improved approach to measuring drug innovation finds steady rates of first-in-class pharmaceuticals, 1987-2011.
abstract: For more than a decade, industry analysts and policy makers have raised concerns about declining pharmaceutical innovation, citing declining numbers of new molecular entities (NMEs) approved in the United States each year. Yet there is little consensus on whether this is the best measure of "innovation." We examined NME approvals during 1987-2011 and propose the three distinct subcategories of NMEs--first-in-class, advance-in-class, and addition-to-class--to provide more nuanced and informative insights into underlying trends. We found that trends in NME approvals were largely driven by addition-to-class, or "me too," drug approvals, while first-in-class approvals remained fairly steady over the study period. Moreover, the higher proportion of first-in-class drug approvals over the most recent decade is an encouraging sign of the health of the industry as a whole.
authors.affiliation: Office of Planning, Food and Drug Administration, Silver Spring, MD, USA. michael.lanthier@fda.hhs.gov
authors.forename: Michael
authors.initials: M
authors.lastname: Lanthier
authors.forename: Kathleen L
authors.initials: KL
authors.lastname: Miller
authors.forename: Clark
authors.initials: C
authors.lastname: Nardinelli
authors.forename: Janet
authors.initials: J
authors.lastname: Woodcock
mesh_terms: D004059:Diffusion of Innovation; D017277:Drug Approval; D015195:Drug Design; D055808:Drug Discovery / Q000639:trends*; D004345:Drug Industry / Q000639:trends*; D015507:Drugs, Investigational; D005544:Forecasting; D006801:Humans; D014481:United States
chemical_list: D015507:Drugs, Investigational
keywords: Biotechnology; Business Of Health; Health Economics; Pharmaceuticals; Public Health