Worries About 180-Day Exclusivity Reforms Persist As User Fee Bill Advances

 
• By Derrick Gingery

FDA-crafted legislative text emerges that generic industry says could weaken the incentive, but so far no changes are in the draft House and Senate bills.

FDA generic legislation
Generic advocates worry FDA's model legislation might render the 180-day exclusivity incentive almost irrelevant. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

More from Generics

More from Biosimilars & Generics