CONGRESS EYES MORE HELP FOR OGD

Author:

The $5-million budget increase approved by the House Appropriations Subcommittee for the FDA?s Office of Generic Drugs (OGD) drew applause from representatives of the generic-drug industry. Although she described the increase as ?modest,? Generic Pharmaceutical Association (GPhA) President and Chief Executive Officer Kathleen Jaeger said that the extra money will allow the FDA ?to hire more reviewers and process generic-drug applications in a timelier manner, which will bring safe, effective, and affordable generics to consumers sooner.?

The extra resources are expected to help OGD officials whittle down the FDA?s current backlog of nearly 1300 generic-drug applications, many of which have been pending for longer than the statutory review time of 180 days. According to GPhA, the median time to approve a generic application is now nearly 17 months. ?OGD?s workload currently overwhelms its resources, and the gap will only increase over the next few years as billions of dollars in brand drug products come off patent,? the association said.