FDA will meet user fee goals

Executive Summary

Shortly after Office of New Drugs Director John Jenkins granted CDER staff permission to miss PDUFA goals, Commissioner Andrew von Eschenbach reaffirmed FDA's commitment to the user fee program. "We intend to live up to the commitments that are outlined in those user fee programs. They will be difficult to adhere to because of the complexities of bringing personnel into the agency," he said at the FDLI conference March 26 (1"The Pink Sheet," March 17, 2008, p. 11). However, "we have a very detailed and month-by-month program with targets and methods of acquisition across the various centers, and ... we have approximately met about one-quarter to one-third of [the] target at this point.