Drug Pricing Bill May Make Six-Month ANDA Review Slower Than Eight-Month Review

 
• By Derrick Gingery
  
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Legislation would create a potential second priority review pathway for generics, as well as another priority review voucher program, but may not be as enticing as GDUFA II proposal.

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House members will consider creating a generic drug priority review pathway different from one already proposed in the pending user fee agreement, although it may not prove faster in all cases. The bill would mandate a six-month priority review for generic applications for drugs with only one sponsor marketing them already or products on FDA's drug shortage list, and could apply to first generics. Those products also would become eligible for a priority review voucher upon approval.

Introduced on Jan. 30 by Reps. Kurt Schrader, D-Ore., and Gus Bilirakis, R-Fla., the bill is intended to help bring...

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