There were problems with the user-fee approach from the beginning. The original legislation required that no portion of companies' fees (about half a million dollars per drug reviewed) could be spent to evaluate drug side effects after approval — the time when many important safety concerns become apparent. The new law mandated strict deadlines for approval decisions. To comply, the FDA reassigned staff scientists to work on new drug applications, pulling the scientists from other regulatory activities. Several were taken from the Office of Drug Safety, which conducts adverse-effects surveillance — a move that helped to shrink and demoralize that unit.Click here to access (registration required; NEJM is offering as a free text article). Please note there are a couple of other free text articles on FDA reform in the same issue.
Wednesday, April 25, 2007
Jerry Avorn, MD, chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital, gives his perspective on the Prescription Drug User Fee Act (PDUFA) in the New England Journal of Medicine: