PDUFA talks stuttering

Negotiations on terms for the second renewal of the Prescription Drug User Fee Act, which expires Sept. 30, appear to be suffering from the lack of leadership at the FDA, according to Pharmaceutical Research and Manufacturers of America President Alan Holmer.

Talks on PDUFA III "are not going as smoothly as they did last time," Holmer said last week at a briefing on PhRMA's priorities for 2002. FDA "had clear leadership" during negotiations for PDUFA II, he noted. "It was able to make decisions, and we have a different circumstance now." ...