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Deloitte Releases Study on Potential Consequences of Follow-on Biologics

Submitted on: 05.04.2009

Member company Deloitte released a study on Monday, Avoiding No Man's Land: Potential Unintended Consequences of Follow-on Biologics, which explores the debate on creating a regulatory pathway for the approval of follow-on biologics (FOBs).  The study examines the recent bills introduced in Congress, which are both based on the model of the Hatch-Waxman Act of 1984, and outlines the potential negative effects of this legislation on innovation.  Jim Hollingshead, author of the report and principal of Deloitte Health Sciences says,  “A regulatory pathway for FOBs can be accomplished while maintaining patient safety, and without destroying the incentives necessary to attract investment into the next generation of breakthroughs."  The report serves as a warning if responsible legislation is not carefully crafted specifically for today's industry, the industry may enter into a "no man's land" which could significantly reduce our ability to continue to develop innovative treatments for the most dreaded diseases.

 Click here to read Deloitte's report.



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