Government Investigation Finds Flaws In the FDA’s Orphan Drug Program

KHN
31 Jan, 2019 ,

The government accountability office uncovered inconsistent and often incomplete reviews early in the process of designating medicines as orphan drugs and recommended “executive action” to fix the system. In some cases, FDA reviewers failed to show they had checked how many patients could be treated by a drug being considered for orphan drug status; instead, they appeared to trust what drugmakers told them.

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