Pharmacy Times, Volume 0, 0

The $5-million budget increaseapproved by the HouseAppropriations Subcommitteefor the FDA?s Office of GenericDrugs (OGD) drew applausefrom representatives of thegeneric-drug industry. Althoughshe described the increase as ?modest,? Generic PharmaceuticalAssociation (GPhA) President and Chief ExecutiveOfficer Kathleen Jaeger said that the extra money will allowthe FDA ?to hire more reviewers and process generic-drugapplications in a timelier manner, which will bring safe, effective,and affordable generics to consumers sooner.?

The extra resources are expected to help OGD officialswhittle down the FDA?s current backlog of nearly 1300generic-drug applications, many of which have been pendingfor longer than the statutory review time of 180 days.According to GPhA, the median time to approve a genericapplication is now nearly 17 months. ?OGD?s workload currentlyoverwhelms its resources, and the gap will onlyincrease over the next few years as billions of dollars inbrand drug products come off patent,? the association said.