Scientific Publications by FDA Staff

Health Aff 2013 Aug;32(8):1433-9

An improved approach to measuring drug innovation finds steady rates of first-in-class pharmaceuticals, 1987-2011.

Lanthier M, Miller KL, Nardinelli C, Woodcock J

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.