Off-label drug promotion now on the table: house and senate voice concerns.

And there is more, much more. If the FDA enforces these requirements, drug companies would probably not be sending around dubious articles based on bogus clinical trials, which is Waxman’s concern. The bigger risk is that physicians might not pay close enough attention to the risks of off-label use, which can be substantial. These risks come into play in connection with atypical antipsychotic agents, which are Grassley’s concern. In the October 2007 issue of P&T, David A. Casey, MD, reviewed the blackbox warnings that the FDA requires for the labeling of atypical antipsychotic agents. He stated: