Danya Institute Inc.

Film Review: Off-Label

Off-Label, this feature film’s title, refers to the practice by some physicians of prescribing a legal drug for a condition or disease for which the drug has not been specifically approved.

Off-Label is quite different from what might be expected for an educational documentary. Rather than presenting a lot of facts or statistics in a traditional narrative, this film is very artistically shot – a real pleasure for the eye that presents a rich, impressionistic tapestry of stories about our “pharma-culture”. It profiles drug-testing subjects (volunteer “guinea pigs”), drug representatives, and people with mental illness or PTSD who have experienced limited success with a pharmalogical approach to managing their symptoms.

There are many emotional moments in this film. Although some of the images and stories are shocking enough to make this film better suited for a “mature” audience, Off-Label is so very well edited that the viewer never feels bombarded. Unlike too many frenetically edited movies these days, the pacing is very well executed; the many scheduled pauses allow the viewer to fully absorb what is being presented.

This film examines the marginal lives of some of the people who volunteer to be drug testers or “guinea pigs”.  Particularly disturbing are the allegations that it is common knowledge that many of the volunteers selected regularly lie or misrepresent facts about their health and suitability for drug testing. In retrospect, this seems quite credible; who but the most desperate among us would otherwise seek to subject their bodies to such a risky endeavor? The viewers must draw their own conclusions about how effectively and adequately some of the drug testing is being conducted.

Another disturbing claim presented by the film is that many primary care physicians dispense medications (particularly antipsychotic ones) in a haphazard and potentially dangerous (off-label) way for unsuited and unintended purposes. Therefore, many psychiatrists find that they must detoxify their patients from drugs incorrectly prescribed by their primary care physicians. Other medical professionals also view off-label use negatively, believing that this practice can increase health care costs, and discourage evidence-based practice. Some professionals do believe, however, that in certain instances ‘off-label’ drug use may be the only option where approved treatments have failed, or are not available (Stafford, 2008).

This non-traditional documentary may present some controversial points and can, therefore, be used to start a much-needed conversation about the current role that pharmaceuticals play in American medicine. As an educational tool, use this film to inspire discussions on: (1) the use and abuse of pharmaceuticals in the US, (2) the possible overdependence in treating conditions with drugs instead of considering alternatives, and (3) the meaning of the term “polypharm” a term which may refer either to the use of multiple medications by one patient, or to excessive and/or unnecessary prescriptions, as described in the film.

Official Off Label Film Website:


Official US Trailer:


Stafford, R. S. (2008).  Perspective: Regulating off-label drug use–rethinking the role of the FDA. New England Journal of Medicine, 358, 1427-1429.

Simone Fary is the Instructional Design and Technology Specialist for the Danya Institute