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September 1st, 2009
Off-Label Prescription Use Driven By Mistaken FDA Approval?

A recent national survey revealed that a considerable minority of physicians inaccurately thought that specific off-label uses of prescription medications had been approved by the U.S Food and Drug Administration.

Author of the research and Assistant Professor of Medicine at the University of Chicago Medical Center, Caleb Alexander M.D., says “Off-label prescribing is common, but researchers have not always known why.  Our research shows that some off-label prescribing might be driven by mistaken beliefs about FDA approval and the level of evidence supporting off-label drug use … the results indicate an urgent need for more effective methods of informing physicians about the level of evidence supporting off-label drug use – especially for common off-label uses that are ineffective or carry unacceptable risks of harm.”

The survey composed of 22 drug-indication pairs – a specific drug prescribed for a specific medical condition – of those, the physicians were able to accurately distinguish the FDA-approval status of roughly half.

The survey was administered during 2007 – 2008 and included 1,199 physicians (of those physicians, 599 were primary care physicians and 600 were psychiatrists), and 22 drug-indication pairs.  The indications were diverse in their FDA approval status from on-label use to off-label use substantiated by medical evidence to off-label use considered incapable.

The FDA states that they only regulate prescription drug marketing, not drug prescription.  Once the FDA has deems a drug adequate for marketing, an official label is created informing health care practitioners of specific indication, dose, intended population and duration of use.  As a result, health care practitioners are not bound to the FDA’s indications on their drug approved list, they may prescribe any approved drug for any indication.

Alexander hopes that their “research will increase awareness of off-label prescribing and highlight the pressing need for more evidence-based use of prescription drugs.”  He continues on to admit that “some off-label uses are well supported, many are not.”

Alexander presents the following disadvantages and advantages of off-label drugs:


Could minimize public expectation that drugs will be gauged for safety and efficacy before use

Blunts industry motivation to perform studies required for FDA label changes

Off-label drugs may have unrecognized safety and efficacy problems

Encourages the use of drugs in populations, such as children and the elderly, for which they have not been tested


Permits clinical innovation, especially for patients who do not respond to standard treatments

Could be the only available option for unique conditions or for unstudied patient populations

Physicians are able to anticipate growing evidence of efficacy before formal evaluation

Increases pharmaceutical return on investment


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