PhRMA concurs with US FDA PDUFA reommendations

Responding to the US Food and Drug Administration's recommndations for reauthorization of the Prescription Drug User Fee Act (PDUFA IV) statement, Billy Tauzin, chief executive of the Pharmaceutical Research and Manufacturers of America said that the significant increase called for in the PDUFA funding proposed by the agency "would provide the resources necessary to improve and modernize the agency's already strong drug safety monitoring system. The FDA already devotes fully half of its pharmaceutical review budget to product safety, and user fees in recent years have been used to hire more agency drug safety officers."

Mr Tauzin concluded that "FDA officials are proposing to make a good system even better. The fact is the combined efforts of the agency and America's pharmaceutical research companies over the years have resulted in the USA having the world's best drug safety record. About 3% of medicines have been withdrawn from the American market for safety reasons over more than 20 years. The vast majority of American patients continue to receive safe and effective treatments."