FDA Asks Industry Where to Draw the Line on Off-Label Communication

Industry proposals to loosen regulations on off-label communication neglect to provide a comprehensive framework for the FDA to monitor unapproved uses, leaving the agency to wonder where boundaries should be drawn.

AdvaMed recommends the FDA expand the scope of scientific information devicemakers can share with healthcare professionals. Scientific findings on the use of a device should not be limited to data from randomized controlled trials, said Khatereh Calleja, AdvaMed’s senior vice president of technology and regulatory affairs.

The FDA should also acknowledge the value of retrospective studies, registries, observational research and meta-analysis, she said at an FDA public hearing on off-label communication.