The proposed United States legislation on data exclusivity prohibits generic competitors from using the data gathered to test a drug’s safety and efficacy for the public as part of their application to the Food and Drug Administration.
“Data exclusivity requires buyers to pay prices protected from normal competition,” says Sandra Adamini, the lead author of the study. “It might even apply if the patent has expired.” Drug companies argue that data exclusivity is needed beyond twenty-year patent protection in order to earn back large investments in research and to provide an incentive for more innovation.
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