GALSON CALLS FOR EXPANSION OF USER FEES, NEW FEE FORMULA IN NEXT PDUFA ROUND

The FDA is calling for two major reforms to its prescription drug user fee program: the ability to use industry fees for an extended postmarket review period and a formula for tying fees to the amount of work the agency must do, according to a high-ranking FDA official.

The agency needs additional resources under the Prescription Drug User Fee Act (PDUFA) to ensure it has the necessary resources to address all the drug safety concerns, said Steven Galson, director of the FDA's Center for Drug Evaluation & Research. The agency also must be allowed to use these fees for a longer period of time, he told FDAnews.

Congress must reauthorize PDUFA by Oct. 1, 2007. It is "really, really key" for the FDA to have additional money to review prescription drugs in both the pre- and postmarketing phases, he said.

But the FDA needs the authority to use these funds for reviews that extend beyond the current two-year postmarket cutoff, Galson said, noting the agency can only use PDUFA funds for postmarketing reviews up to two years after the initial drug approval.

However, many of the most visible health problems associated with drugs do not appear until years later, such as with Merck's Vioxx and other Cox-2 inhibitors, Galson noted.

The agency is now negotiating with lawmakers to extend this cutoff "many more years" past the current period in order to continue to assess drug safety, he said. "We really feel it's important we have the resource flexibility" to review drugs many years down the line, Galson added.

In addition, the agency is negotiating for a formula that would tie fee amounts a company pays to the number of meetings it has with the agency, Galson said. These meetings are "time-intensive on the part of our staff" and need to be taken into account when fees are set, he said. (http://www.fdanews.com/did/5_70/)