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This service is more advanced with JavaScript available, learn more at http: The experience with the US programme continues to serve as a useful reference point as interest in orphan drug incentive programmes expands globally. This article first reviews details of the legislation and orphan drug regulations, and then provides a year overview — of orphan drug activity in the US, including descriptive data on the designated and approved orphan drugs, their indications and sponsors. Over the year analysis period, the FDA granted orphan designations involving different drugs, for which FDA marketing approvals have been granted. Those with both treatment investigational drug designation and fast-track approval status appeared to benefit substantially from shorter development times. Evident in the latter part of the analysis period is the increasing share of orphan activity attributable to biotechnology firms.
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FDA Commissioner: Are The Incentives Right For Orphan Drugs?

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FDA's Gottlieb Says He's Open To Rethinking Incentives For Orphan Drugs : Shots - Health News : NPR

The European Medicines Agency EMA will be publishing, as of today, a so-called orphan maintenance assessment report for every orphan-designated medicine which has been recommended for marketing authorisation by the Agency. The new report summarises the reasoning of the Agency's Committee for Orphan Medicinal Products COMP on whether or not a medicine designated as an orphan medicine during its development still fulfils the designation criteria at the time of its authorisation. This is the precondition for it to benefit from ten year market exclusivity , one of the incentives of the European Union EU orphan programme. To qualify for orphan designation , a medicine must target a disease that is life-threatening or chronically debilitating that affects less than 5 in 10, patients in the EU. If there is already another treatment available for the targeted rare disease, the developer of the new medicine must show that there is a significant benefit to patients compared to the existing options, meaning the medicine provides a clinically relevant advantage or a major contribution to patients. The COMP assesses whether a medicine fulfils the criteria for orphan designation at two points in time: Orphan designation gives access to a number of incentives to foster research and innovation, including fee reductions for scientific advice and ten year market exclusivity when the medicine is authorised in the EU.
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The US Orphan Drug Programme

Scott Gottlieb, Food and Drug Administration commissioner, told Kaiser Health News the incentives intended to spur development of drugs for rare diseases deserve a fresh look. Food and Drug Administration Commissioner Scott Gottlieb is questioning whether the law that encourages drugmakers to develop medicines for rare diseases is working the way it should. In an interview this week, Gottlieb said the Orphan Drug Act of has provided "an enormous amount of public health value" over the years. But the "market has changed," he said, and it's time to ask:
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An original signature of an individual representing the sponsor organization is required on one copy of the orphan drug designation request — typically the cover letter. The original signature does not have to be the contact person. An orphan drug designation can be submitted on a single compact disk CD with a signed cover letter attached. It is preferred to be sent by regular or express mail.
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