NOVEMBER 01, 2006

Makers of generic drugs may soon have to ante up to the FDA to have their products reviewed, just as their brand name counterparts do now. In the past few months, the FDA launched a study as to whether or not revenue generated from these fees would hasten the review process for more than 800 generic drug applications currently pending. Currently, generic drug makers are exempt from FDA review fees because the applications for generic drugs usually take less time and effort to review.

Over the last 5 years, however, the number of generic drug applications has more than doubled. FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb suggested that the fees could be used to hire more help for the Office of Generic Drugs to speed up the application process.

Kathleen D. Jaeger, president of the Generic Pharmaceutical Association, is not so sure that the strategy will work. "Our problem with user fees is that they currently would not guarantee that generic drugs would be reviewed and approved any faster," she said. "There are many other legal and regulatory obstacles... and they would have to be addressed before the industry could feel comfortable with any user-fee program."

It is too soon to estimate what effect the fees would have on the prices drug makers would charge to consumers for generic medicines or the profits they would reap from them. Brand name drug makers pay an average of $896,200 for each application they submit to the FDA for review.