Number of FDA “orphan drug” designations rising dramatically

This short article by Gayatri Rao, the Food and Drug Administration's director of Orphan Products Development, explains that, in recent years, drug companies have been filing many more "orphan drug" applications than they used to. Orphan drugs are drugs aimed at treating people with rare diseases. Drug companies sometimes say that it's too costly for them to develop orphan drugs given the small potential market for some orphan drugs. Among other things, Rao discusses incentives federal law provides for companies to develop orphan drugs — such as tax credits, a post-approval period of market exclusivity, and, most recently, waiver of "user fees" for company submissions that apply to regular drug applications.

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