Experts: Orphan Drug Act’s Cost Recovery Path Stifles Competition

Lawmakers and experts are pushing for reforms to stop alleged gaming of the Orphan Drug Act’s cost recovery pathway, which is designed to let drug makers obtain an orphan drug designation if they show they won’t recover their development costs. The cost recovery pathway so far has only been used three times – with two of the orphan drug designations going to profitable buprenorphine-based products. Lawmakers hope to reform the pathway so that other drug makers, including those in the...