GENERICS MAKERS MAY BE CHARGED FDA FEES

Pharmacy Times, Volume 0, 0

Makers of generic drugs may soonhave to ante up to the FDA to have theirproducts reviewed, just as their brandname counterparts do now. In the pastfew months, the FDA launched a study asto whether or not revenue generatedfrom these fees would hasten the reviewprocess for more than 800 generic drugapplications currently pending. Currently,generic drug makers are exempt fromFDA review fees because the applicationsfor generic drugs usually take lesstime and effort to review.

Over the last 5 years, however, thenumber of generic drug applications hasmore than doubled. FDA Deputy Commissionerfor Medical and ScientificAffairs Scott Gottlieb suggested that thefees could be used to hire more help forthe Office of Generic Drugs to speed upthe application process.

Kathleen D. Jaeger, president of theGeneric Pharmaceutical Association, isnot so sure that the strategy will work."Our problem with user fees is that theycurrently would not guarantee thatgeneric drugs would be reviewed andapproved any faster," she said. "There aremany other legal and regulatory obstacles...and they would have to be addressedbefore the industry could feelcomfortable with any user-fee program."

It is too soon to estimate what effect thefees would have on the prices drug makerswould charge to consumers for genericmedicines or the profits they would reapfrom them. Brand name drug makers payan average of $896,200 for each applicationthey submit to the FDA for review.