PrintThe Burrill Report (June 1, 2010): Does the Industry Get Its Money's Worth from Drug Review Fees (.MP3,9.63 Mb)
The U.S. Food and Drug Administration has sought to address its lack of resources and accelerate the speed with which it reviews applications for new drugs and biologics through fees imposed on the pharmaceutical and biotechnology companies whose products it reviews. The fourth incarnation of the so-called Prescription Drug User Fee Act or PDUFA, which first passed in 1992, expires at the end of September 2012. Its reauthorization is moving toward the top of the industry’s policy agenda. PDUFA fees have more than doubled since fiscal 2007 to $667 million and now account for two-thirds of the total spent on human drug reviews. Recent data suggest that despite improvements credited to PDUFA, performance under the program has been slipping. We spoke to Peter Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner of the FDA about reauthorization of the act, how to view the agency’s performance, and whether the industry is getting the intended benefits from the fees it pays.
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