One exclusive marketing period per drug?

> Current law clearly prohibits Food and Drug Administration (FDA) from restricting a generic drug to overlapping, or concurrent, exclusive marketing periods - one for being the first generic and another for undertaking a pediatric-use clinical study - rather than allowing them to run consecutively,

The GPh-A wrote in response to an FDA request for public comment about the possibility of the two incentives running concurrently.

Earlier this year, the FDA stirred up controversy when associate commissioner for legislative affairs Melinda Plaisier wrote to Sen. Orrin Hatch (R. UT) indicating that "while we acknowledge that it is your position that the intent of the authors of both pediatric and 180-day exclusive provisions was that they run consecutively and not overlap, we have been unable to find any statutory language that supports that." The GPhA told the FDA that "the relevant statutory language confirms that pediatric exclusivity and generic exclusivity are separate and distinct awards that were intended to run consecutively, not concurrently."