FDA user fee deal to face US Congress OK

The US Food and Drug Administration has reported the agreement of a deal with drugmakers to renew and improve the arrangements for user fees under the 1992 Prescription Drug User Fee Act. The proposals have been welcomed by both the agency and the drug industry. However, the final decision to renew or amend the PDUFA's provisions rests with the Democrat-controlled US Congress, where pressure will be brought to either scrap the user fees - on the grounds that these "compromise" the FDA's independence - or to extract tougher conditions from drugmakers. The new regime is due to take effect in fiscal 2008.

Jim Greenwood, president of the Biotechnology Industry Organization, said: "the PDUFA recommendations announced today are a win-win." He added that additional FDA funding of $150.0 million over five years, via the user fees, would "further its public health mission while continuing to enable access to safe and effective medical products." The BIO's statement was echoed by Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America (PhRMA), who noted the inclusion of a five-year plan to improve adverse drug reaction reporting.