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Jumping Legal Hurdles with the US FDA: The Generic Inhaler Challenge

Karst KR.

RDD Asia 2014. Volume , 2014: 151-158.

Abstract:

The ability of the Food and Drug Administration (FDA, “the Agency”) to approve generic or follow-on versions of inhaled drug products raises difficult and novel legal issues, as well as complex scientific and regulatory issues. The FDA’s resolution of these legal issues could delay approval of substitutable generic equivalents; however, that same delay could also lead to a host of innovative inhaled drug delivery devices that are not substitutable for other approved inhaled drug products at the US pharmacy outlet. This article attempts to describe some of the legal and regulatory challenges – particularly with respect to the issues concerning drug delivery devices that the FDA faces as the Agency moves slowly toward generic approval – and how manufacturers’ efforts to avoid some of those challenges could result in product innovation.