To the Editor: In their Commentary criticizing the guidelines proposed by the Food and Drug Administration (FDA) on off-label promotion, Drs Psaty and Ray1 point to shortcomings in the peer-reviewed literature about unapproved uses of approved drugs and devices. However, in focusing on sponsors' distribution of such literature, the authors fail to recognize the full extent of the problem.
Dresser R. Off-Label Indications for Medication Use and the Published Literature. JAMA. 2008;300(12):1411-1412. doi:10.1001/jama.300.12.1411-b