It is becoming clear that the Nissen article in the NEJM is part of larger effort on the part of a tort lawyer sponsored group of academics who oppose PDUFA. The editorial in support of the Nissen article was written by Curt Furberg and Bruce Psaty who, as this blog has noted in the past, have participated in the efforts of the The Project on Scientific Knowledge and Public Policy (SKAPP), based at the George Washington University to undo current PDUFA legislation. Major support for SKAPP is provided by the Common Benefit Trust, a fund established pursuant to a court order in the Silicone Gel Breast Implant Products Liability litigation.
It's time for the FDA to stand up to the bullying if it wants to retain authority...
It's time for the FDA to stand up to the bullying if it wants to retain authority...
