by Marc Boutin
Policy Forum (Volume 2, Number 15, August 8, 2012) explores implementation options for the long-awaited Prescription Drug User Fee Act V (PDUFA V) – How Should FDA Align Benefit-Risk Drug Evaluations Stipulated By PDUFA V With The Needs Of The End Users – Patients? The author, Marc Boutin, Executive Vice President and Chief Operating Officer of the National Health Council, will explain that under PDUFA V, FDA is required to create a qualitative framework that analyzes the benefits and risks of new drugs. Boutin asserts that FDA’s current method of evaluating drugs is ad hoc and informal. He recommends that FDA create a qualitative benefit-risk framework by receiving input directly from patients across the entire spectrum of conditions. Patients with chronic conditions have a different perspective on the benefits and risks of new drugs, and therefore need to be engaged by FDA, he concludes.
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