FDA Jobs?
In the January 2007 issue of Drug Discovery & Development, Ted Agres authored an informative article called "FDA's Sweeping Changes" that outlined reforms that are slated to occur at the agency. One of these is an amendment to the Prescription Drug User Fee Act (PDUFA; which is up for renewal) to increase user fees for regulatory reviews. For those of you who are not familiar with PDUFA, it was passed in 1992 and it authorized FDA to collect fees from industry to hire additional staff to meet faster approval goals for Investigational New Drug (IND), New Drug (NDA) and Biological License Applications (BLA). Under PDUFA, user fees have grown from $9 million or 7% of FDA's drug review costs in FY1993 to ca. $ $280 million or more than 59% in FY 2007 which began on Oct. 1, 2007.
In addition to being used to speed drug review, the new fees will support post-market surveillance and post-market evaluation of drug safety. Further, for the first time, drug manufacturerers have agreed to provide user fees to support FDA review of direct to consumer advertising (DTC). At present, FDA has no authority over DTC ads prior to drug launch; companies submit copies of broadcast and print ads when they begin running. FDA is seeking the authority to review DTC ads before they can be aired or printed.
Increases in user fees suggest that the agency ought to be looking for a few "good women and men" to review regulatory submissions and institute its new focus on drug safety and surveillance.
Until next time......
Good Luck and Good Job Hunting!!!!!!!
