A catalyst for change? Orphan drugs and the case of C atalyst v. Becerra.

However, the Orphan Drug Act is intended to increase I approvals i for treatments for orphan diseases, and it appears that Catalyst just may have served the intent of the ODA by being the first company to take and complete the path that the ODA created for that very purpose. FDA took the unique approach (FDA's admission) of "administratively dividing" Jacobus's NDA into pediatric and adult populations. It is not clear why Jacobus required 27 years (1990-2017) from the grant of orphan drug status to file its initial NDA, but Jacobus apparently had been selling its product under FDA's compassionate use exemption for 25 years (1993-2018) before Catalyst finally got official FDA approval (thereby cutting Jacobus out of its market). [Extracted from the article]