New Rules When Scientists Disagree at FDA (Orthopedics This Week)
What happens when you go to the FDA with an application and the scientists within the agency disagree about the science behind your device or procedure?
These disagreements lie at the heart of the lawsuit by the FDA 9 whistleblowers over exposure to radiation. Internal disagreements and the ensuing public prosecution by The Wall Street Journal of Regen Biologics, Inc. and their appeals process brought down the company's application and, according to some, hastened the departure from the agency of Dan Schultz, M.D., the former Director of the Center for Devices and Radiological Health (CDRH).
ReGen eventually filed for bankruptcy. Internal scientific disagreements within the agency have serious consequences when promoting public health and bringing new technologies to patients.
The FDA is trying to do something about it.
On September 4, 2012, the FDA announced the implementation a new "Standard Operating Procedure (SOP) for Resolution of Internal Differences of Opinion in Regulatory Decision-Making."
This document sets forth the general policy for the CDRH for resolving internal differences of professional opinion and...
