FDA'S USER FEE PROPOSAL PLACES GREATER EMPHASIS ON DRUG SAFETY
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 a Jan. 11 announcement, 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 agency wants to use these increases to improve its drug safety system, which has been under fire as of late. The funding would provide "an impressive expansion and modernization of our drug safety system," FDA Commissioner Andrew von Eschenbach said in a statement.
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.
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.
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.
Industry groups, who were an integral part of the negotiations, supported the agency's proposals. The recommendations are "designed to make sure millions of patients continue to receive safe and effective medicines in a timely manner," Billy Tauzin, PhRMA's president and CEO, said. "The proposals are also designed to make sure new drugs, once they're on the market, continue to offer safe and effective therapy throughout their shelf life."
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).