PwC Report Highlights Industry Skepticism of FDA User Fees

As the FDA continues its negotiations with industry in advance of the reauthorization of the Prescription Drug User Fee Act, a new survey is highlighting drugmakers’ skepticism of the fees’ effectiveness and reinforcing calls for more frequent communication with the agency. According to the Improving America’s Health survey by PricewaterhouseCoopers (PwC), nearly half of the 50 life science companies surveyed said they were unclear on the purpose of the user fees. In addition, 24 percent of the companies believed the FDA is applying the fees as intended and 32 percent said the fees accelerate the agency’s review process.
Drug Industry Daily