As FDA continues its wholesale review of policies governing off-label communications by device and drug companies, the agency got an earful on both sides of the issue at two-day public hearing held at its headquarters. At the Nov. 9-10 gathering, manufacturers asked for much more freedom to disseminate off-label information while patients and patient advocates expressed concern the move could endanger the public health.
The meeting took place in the context of a string of court decisions that have pushed back on FDA's interpretation...