Fees don’t threaten FDA independence
“There should be no confusion about who FDA serves,” he said. “It’s important to get drugs rapidly to market, but rapid does not mean reckless…We’re not focused on where our resources come from—only on what they allow us to do.”
Von Eschenbach indicated that administrative changes were under way to place the agency’s drug review program on a sound financial footing; enhance the process for premarket review of human drug applications; and modernize and transform the postmarket safety system.
In addition, the FDA presented a related proposal (separate from PDUFA) that would assess fees for advisory reviews of DTC television advertisements.
FDA associate director for policy Jane Axelrad said only firms that voluntarily submit DTC TV ads for advisory review will pay the fees, projected to be $6.25 million annually, adjusted for inflation and workload.
She explained there would be a one-time participation fee in the first year of the program, based on anticipated submissions, and annual pre-payment for advisory reviews thereafter. The cost for each submission will be $6.25 million divided by the number of submissions that are identified by sponsors.