[Ip-health] Public Citizen report on 21st Century Cures orphan drug exclusivity provision
sknievel at citizen.org
Fri Dec 11 09:42:25 PST 2015
This week, the Health Research Group and Access to Medicines divisions of Public Citizen jointly published this report on a new orphan drug exclusivity provision included in the 21st Century Cures legislation passed by the House of Representatives this past July.
We estimated that, if enacted, the provision, which would provide an additional 6 months of exclusivity for all indications when an existing product successfully receives a new orphan indication, could cost U.S. taxpayers and patients up to $12 billion over 10 years. Further, the report explores ways companies may seek to abuse the system to gain more orphan drug approvals (and the added monopoly period that comes with it).
View the report here: http://www.citizen.org/documents/2289.pdf
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