Bill would grant vouchers, speed review for generic competitors

Sens. Susan Collins (R-Maine) and Claire McCaskill (D-Mo.) introduced a bill Thursday that would require FDA to award Priority Review vouchers and take other steps to spur competition among generic drug manufacturers. The bill would prioritize review of ANDA applications for generic drugs that are produced by only one other company.

The Increasing Competition in Pharmaceuticals Act ( S. 2615) would grant transferable Priority Review vouchers upon approval of generics that do not have at least two manufacturers, or for which FDA has granted tentative approval to no more than two applications. The vouchers would speed generic drug review and could not be applied to new drug applications. The program would sunset on Oct. 1, 2022. ...