Sher Quoted in MM+M on FDA Orphan Drug Exclusivity System

FDA restores orphan-exclusivity system after 18-month stall in wake of legal feud
– MM+M

Manatt Health Partner Rachel Sher was quoted in an MM+M article about the Food and Drug Administration’s (FDA) recent action that has major implications for how FDA will award orphan drug exclusivity following an 11th Circuit ruling in Catalyst Pharmaceuticals, Inc. v. Becerra. “Although clarity as to FDA’s attention with respect to awards of orphan drug exclusivity is finally here, it’s likely to be short-lived without a statutory fix,” Sher said. “Further litigation can be expected by parties that would benefit from a broader award of exclusivity under the Catalyst court’s interpretation of the Orphan Drug Act,” she added. “So this issue is surely going to arrive at Congress’s doorstep again.” 

Read the full MM+M article here.  

Read more about the Orphan Drug Act in Sher’s newsletter here



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