"A bill was introduced in the U.S. Senate late last week that would provide a drug maker with an unprecedented 15 years of data exclusivity for a medicine that meets an unmet medical need."

"The legislation – which is essentially a companion piece to a bill that was introduced last year in the U.S House of Representatives – is called the Dormant Therapies Act. The idea is to offer an incentive to drug makers, which would have to request that a new drug – and only a new drug – is designated as a dormant therapy by the FDA."

"Currently, drug makers can receive five years of data exclusivity for a new prescription medicine and 12 years for a biologic. However, the pharmaceutical industry has regularly complained that time-consuming R&D needed to obtain regulatory approval eats away at exclusivity periods, effectively preventing drug makers from gaining the full benefit."

"The bill closely resembles the Modernizing our Drug & Diagnostics Evaluation and Regulatory Network Cures Act. Also known as the Modern Cures Act, this legislation also offers 15 years of data exclusivity for new medicines that are designated as dormant therapies that would address unmet medical needs. Although it has not made any progress, there are now 94 co-sponsors."

"The underlying notion in both bills, however, has also been criticized over concerns that, by extending data exclusivity beyond the existing timeframes, the law could slow the introduction of lower-cost generic versions of many drugs."

From Pharmalot – +Wall Street Journalhttp://ow.ly/FZ9NL

Senate Bill Offers 15 Years of Data Exclusivity for Drugs for Unmet Needs
A bill was introduced in the U.S. Senate late last week that would provide a drug maker with an unprecedented 15 years of data exclusivity for a medicine that meets an unmet medical need.

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