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

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

Advocates remain worried about the potential for an overhaul of the 180-day exclusivity incentive for generic drugs now that legislative text of the US Food and Drug Administration’s proposal has surfaced.

The House and Senate versions of the bill so far do not include any adjustments, but with the Senate committee...