At NORD’s Rare Disease and Orphan Drug Breakthrough Summit held in Washington D.C., October 15-16, 2017, we talked with Kurt Karst of Hyman, Phelps, and McNamara.
As Karts states in this video, under the Orphan Drug Act when a product is approved, the FDA grants a period of 7 year drug exclusivity and that exclusivity prevents FDA from approving the same drug, the same molecule, for 7 years unless another product comes along that's different. And a product can be different if it's what's referred to as clinically superior and if it is shown to be clinically superior it would break that other sponsors orphan exclusivity.
There are 3 ways to show this superiority. One is if you show greater efficacy. One is if you show greater safety. And another one is if your product provides what's referred to as a mick to pick or major contribution to patient care.
Over the past couple of years there's been litigation in which companies have challenged FDA's regulations, as Karst explains.