FDA commissioner Margaret Hamburg says it's taking the agency too long to approve generic drug applications and imposing user fees on generic drug companies could help speed the process. Company officials said they could accept fees if there are performance metrics to guarantee prompt action.
In a February speech to the Generic Pharmaceutical Association, Hamburg said the large backlog in generic drug applications “is a real problem. I don't pretend to believe that the status quo is acceptable.” Five years ago, FDA approved a new generic drug on average within 16.3 months of the filing. That time has increased to 26.7 months.
Hamburg said the slow-down stems not only from limited resources in the Office of Generic Drugs, but also from an increase in the number of applications in the last few years. In addition to recommending user fees, Hamburg said she would like to see a priority-setting system that would help FDA identify “the most critical drugs in terms of public health and patient access and move those more quickly.”