PhRMA welcomes US Congress' timely PDUFA renewal, FDA budget crisis avoided

The president of the Pharmaceutical Research and Manufacturers of America (PhRMA), Billy Tauzin, has welcomed the US Congress' passage of the Prescription Drug User Fee Act re-authorization legislation (Marketletters passim). "In passing the re-authorization of the Prescription Drug User Fee Act, the US Congress has taken a crucial step to make our nation's drug safety system - which already is the best in the world - even better," he said. The Senate approved the legislation unanimously on September 20, after an overwhelming majority the previous day in the US House of Representatives. If the legislation had not been approved by the end of that week (September 21), the Food and Drug Administration could have been required to issue redundancy notices to up to 2,000 staff.

Mr Tauzin added that "the legislation provides the Food and Drug Administration with [the] additional resources it needs to promote and protect the public health. The increased fees will allow the agency to expand drug safety monitoring, hire additional staff for post-market surveillance and modernize its information technology systems."

Among the provisions of the new version of the PDUFA, which was first enacted in 1992 and is renewed every five years, the FDA will have the capacity to modernize its adverse events reporting system for collecting and aggregating safety data, enhance its use of epidemiology studies and medical databases and better evaluate risk communication, as well as risk management programs.