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off-label, false claims, physician learning, post-marketing clinical research


Over half of the FDA-approved prescription medications taken by patients are prescribed for a different purpose, in a higher or lower dose, for a discrete population, or over a longer period of time than that for which the drug was approved. Safety and efficacy concerns attract the most attention; but critical benefits in fostering innovation and providing patients with medications that may be uniquely effective for them are often overlooked.

The current dominant public policy response to off-label prescribing addresses this practice as a particular breed of financial conflicts of interest in which pharmaceutical firms pollute medical judgment by appealing to the financial self-interest of physicians. This conflicts-of-interest approach, however, including that embodied in the current campaign of False Claims Act litigation, relies on untenable assumptions concerning clinical knowledge. It mistakenly assumes that once the polluting factor is eliminated, a purer environment with adequate information for prescribing will remain.

This article begins by examining the literature on physician learning and how learning patterns affect off-label prescribing and weaken demand for post-approval clinical trials. It then describes deficiencies in contemporary clinical research and analyzes how they reinforce skepticism toward research on the part of physicians and hamper regulators in determining whether off-label prescriptions are appropriate. Finally, this article uses landmark False Claims Act litigation, which resulted in a $455 million settlement paid by a manufacturer for marketing, education and research activities relating to off-label use of a single approved drug, as a lens to illustrate the inherent limitations of the conflicts-of-interest approach.