![]()
The FDA clearly has a good case when it comes to calling for new fees to fund generic drug applications. As mainline pharma companies are all too aware, if you expect to see the agency improve its performance, you need to be willing to step up to the plate with real support. It's essential that the transformation of a drug from branded to generic occur efficiently. The markets need lower cost knock-offs, particularly as a new generation of much more expensive biologics is introduced. With new user fees, the FDA will have the money needed to deal with the backlog of generic applications. Without that revenue stream, we can all expect the backlog to grow steadily. - John Carroll