Duke Center Floats Tiered Labels, 3rd Party Review As Possible Off-Label Solutions

The recently formed Duke-Margolis Center for Health policy, headed by former FDA Commissioner Mark McClellan, is floating tiered drug labeling and third-party reviews as a possible path forward in the heated debate over FDA's role in policing off-label promotion of drugs. A center working group also urged FDA to quickly clarify what drug manufacturers can and can't say regarding off-label uses in order to put the agency back in the driver's seat following recent losses in federal courts over the...