US Biologics Price Competition and Innovation Act debated: BIO versus GPhA

16 February 2009

The future of the US biotechnology drug market is the battleground for a debate underway between the research-based and generic trade  associations, the Biotechnology Industry Organization and the Generic  Pharmaceutical Association (GPhA), respectively. Both groups are  supporting their lobbying efforts in the new congressional session by  drawing on research from a range of sources to bolster their own case  and demolish their opponents'.

Perhaps the most surprising research paper written about the issue of a  follow-on regulatory pathway for biotechnology compounds was sponsored  late last year by the Israel-based generic drug giant, Teva  (Marketletter November 24, 2008). The author of a paper, titled Proper  Duration of Data Exclusivity for Generic Biologics: a Critique, was Alex  Brill, a research fellow at the American Enterprise Institute, a free  market-oriented think-tank that would normally be expected to side with  more strict interpretations of intellectual property rights. The  12-page document set out to demolish claims by a research paper  published in the Nature Reviews Drug Discovery journal, authored by  Duke University economist Henry Grabowski, which had argued in favor of  the BIO's position, which is to demand at least 14 years of data  exclusivity (Marketletters passim).

Seven years enough for data exclusivity?

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