FDAnews Drug Daily Bulletin

Pharma Blog Watch

Aug. 20, 2012
A A
GAINs Are Yet to Be Seen (Drug Wonks Blog)
The passage of the Generating Antibiotic Incentives Now (GAIN) provisions in the recent Prescription Drug User Fee Act agreement is being applauded for adding incentives like an additional five years of market exclusivity and priority review for qualifying antibiotics. “But they may not be the game-changing incentives as some in the industry hoped,” blogger Peter Pitts writes. High development hurdles for antibiotics, the availability of low-cost generics and reimbursement challenges for pricey new antibiotics are likely to keep most investors on the sidelines at least until big pharma starts to show more interest in the space, he writes.