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[Viewpoint] Outrageous prices of orphan drugs: a call for collaboration

Few instances of a single act of legislation have shifted industrial policy in the pharmaceutical industry like the Orphan Drugs Act did when it was signed in the USA in 1983. The Act was written to facilitate the development of drugs for rare diseases and health conditions,1 and the incentives provided by the Act, such as 7 year exclusivity, tax credits of up to 50% of research and development costs, and access to research and development grants, resulted in the US Food and Drug Administration2 (FDA) approving 575 drugs and biological products for rare diseases between 1983 and 2017—a real success.

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