The Food and Drug Administration (FDA) proposed recommendations to Congress for the next reauthorization of the Prescription Drug User Fee program which, if adopted, would significantly broaden and upgrade the agency’s drug safety program, increase resources for review of television drug advertising, and facilitate more efficient development of safe and effective new medications for the American public.
To achieve these public health benefits, the agency proposes to recommend, as part of the reauthorization of the program, that annual user fee collections be increased to $392.8 million, an $87.4 million increase over the current base line.
The user fee program, which was first authorized by the Prescription Drug Use Fee Act (PDUFA) in November 1992, adds industry’s funds to the agency’s appropriations to help FDA’s human drug review program achieve demanding performance goals. Over the years, the PDUFA programs, which have to be reauthorized by Congress every five years, have enabled the agency to dramatically reduce its review times for drugs and biological medications while increasing scientific consultations, clarifying issues involving drug development, and increasing oversight of postmarket safety.
“The proposed recommendations would support significant improvements in FDA’s ability to monitor and respond to emerging drug safety issues, as well as continuing FDA’s commitment to scientific improvements and streamlining the drug approval process,” said HHS Secretary Mike Leavitt. “I commend FDA for the important progress they have made and look forward to working with Congress to ensure action on these proposals.”