Footnotes (242)



Polluting Medical Judgment? False Assumptions in the Pursuit of False Claims Regarding Off-Label Prescribing

Sandra H. Johnson

Saint Louis University - School of Law

Minnesota Journal of Law, Science & Technology, Vol. 9, 2007

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.

Number of Pages in PDF File: 65

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

Open PDF in Browser Download This Paper

Date posted: July 11, 2007  

Suggested Citation

Johnson, Sandra H., Polluting Medical Judgment? False Assumptions in the Pursuit of False Claims Regarding Off-Label Prescribing. Minnesota Journal of Law, Science & Technology, Vol. 9, 2007. Available at SSRN: https://ssrn.com/abstract=999418

Contact Information

Sandra H. Johnson (Contact Author)
Saint Louis University - School of Law ( email )
100 N. Tucker Blvd.
St. Louis, MO 63101
United States

Feedback to SSRN

Paper statistics
Abstract Views: 1,271
Downloads: 139
Download Rank: 165,556
Footnotes:  242