FDA'S USER FEE PROPOSAL PLACES GREATER EMPHASIS ON DRUG
Improved drug safety is foremost in the FDA's Prescription Drug User Fee Act (PDUFA) proposal that seeks new authority and more than $29 million in additional fees specifically to improve its postmarket safety surveillance.
The agency, in an announcement Jan. 11, requested $392.8 million in user fees as part of its recommendations for the reauthorization of PDUFA. The amount represents an $87.4 million overall increase over the current fee baseline. The agency will hold a public meeting Feb. 16 on its recommendations. Then, after it makes changes based on these comments, the proposal will be submitted to Congress. PDUFA must be reauthorized by Oct. 1.
The FDA would allocate $29.3 million of the additional fees to improving the agency's capacity for drug safety surveillance after a product has been approved. As part of that effort, the FDA would hire 82 additional employees for postmarket safety work.
Furthermore, the FDA wants a new fee program created to pay for the agency's review of direct-to-consumer television ads. The agency anticipates that these fees will amount to $6.2 million in the first year and allow the FDA to hire 27 additional review staff. The FDA has been angling for additional funds to speed review of these ads.
The FDA also wants new authorities. The agency is requesting that PDUFA be changed to allow the FDA to address safety issues beyond the current three-year postmarketing period.
The agency's proposal can be seen at www.fda.gov/OHRMS/DOCKETS/98fr/07n-0005-nm00001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/07n-0005-nm00001.pdf).