FDA, Industry Agree On Drug User Fees

FDA and the pharmaceutical industry have struck a deal, agreeing to raise industry user fees by 6% above fiscal 2012 levels in exchange for enhanced communication and more consistent drug approvals. FDA published the draft recommendations on Sept. 1, after months of negotiations with drugmakers. Under the proposed agreement, FDA would train its drug reviewers to more effectively communicate with industry and develop performance goals to speed up drug reviews. FDA would also focus more on tracking adverse events after drugs have reached the market and on implementing measures to reduce medication errors resulting from “look-alike” and “sound-alike” drug names. The current Prescription Drug User Fee Act, which provides about 60% of FDA’s drug review budget, is set to expire in September 2012. Industry is pushing lawmakers to reauthorize the act quickly so that FDA is not forced to cut back on its drug review staff.