The article highlights comments made by authors who contributed to the book recently co-edited by the Catalyst team and published by the Food and Drug Law Institute (see release, below, on PDUFA and the Expansion of FDA User Fees: Lessons From Negotiators). The authors spoke during a panel discussion on user fees at the FDLI annual meeting. Moderated by Catalyst President Nancy Myers, the panel included comments by Alan Goldhammer, former PDUFA negotiator for PhRMA; the article notes Goldhammer’s take on the potential for user fees to spread beyond FDA, throughout government-regulated industries, and for user fees to approach 100% of FDA drug review funding. The article also highlights comments by CDER Director Janet Woodcock, who contributed a chapter to the book.
“FDA and User Fees: Time to Give 100%?”
The RPM Report