FDA commissioner Scott Gottlieb announced Tuesday that the agency will release guidance to close a loophole that allows companies to avoid their obligation to study pharmaceuticals in pediatric populations.
The situation, according to Gottlieb, arises if sponsors received an orphan designation for a pediatric subtype of an otherwise common and non-orphaned adult disease.
For example, with a condition like inflammatory bowel disease, a drug may be approved to treat the large population of adults with the condition but then the same drug may be granted an orphan designation to treat a subset of children suffering from IBD.
