Letters Pharmaceutical research and development

Drug development: Innovation or imitation deficit?

BMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e5880 (Published 04 September 2012) Cite this as: BMJ 2012;345:e5880
  1. Steven G Morgan, associate director1,
  2. Colleen M Cunningham, PhD student2,
  3. Michael R Law, assistant professor3
  1. 1Centre for Health Services and Policy Research, University of British Columbia, Vancouver, BC, Canada V6T 1Z3
  2. 2Fuqua School of Business, Duke University, Durham, NC 27708, USA
  3. 3School of Population and Public Health, University of British Columbia
  1. morgan{at}chspr.ubc.ca

Light and Lexchin argue that the pharmaceutical innovation crisis is a myth.1 Although they correctly diagnose the issue, the drug approval data provided tell only half of the story. To shed more light on drug development trends, we classified US Food and Drug Administration approvals of new drugs (therapeutic new molecular entities) into one of three mutually exclusive categories: first-of-kind drugs to be approved within chemical or biological subgroups and early or late follow-ons that were approved within 10 years or more than 10 years after first-of-kinds, respectively.

The figure shows that average rates of first-of-kind drug development have been relatively stable for 30 years. The recent rise and fall in total drug development is largely explained by changes in follow-on competition. Follow-on competition occurs if it is technically and legally possible to effectively imitate a pioneer, and if the market allows resulting products to be priced at a sufficient premium.2 The blockbuster markets of the 1990s were ideal for this, but our data suggest that by the 2000s the clinical and economic opportunities for such competition had declined considerably.


Five year averages of all therapeutic new molecular entities (NMEs) approved by the US Food and Drug Administration by degree of novelty, 1946-50 to 2006-10

The recent decline in follow-on drug development—an “imitation crisis” if anything—probably results from the transition from small molecule drug development for large primary care drug classes to more specialised drug development.3 This decline might be expected because patents may bar entry more effectively and markets may be too small to incite competition.

Thus, while first-in-class drug development rates have not significantly deviated from long term trends, the sector today bears little resemblance to that of a decade ago. New policy challenges replace old ones. Advances in regulation and transparency are always welcome; however, solutions for dealing with problems of the past—such as Norway’s medical need clause or innovation prizes—may have less effect in the increasingly specialised pharmaceutical marketplace.


Cite this as: BMJ 2012;345:e5880



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