Two physicians describe how some drug companies may promote off-label use — prescribing drugs for a purpose outside of their approved use.
Adriane Fugh-Berman of Georgetown University Medical Center and Douglas Melnick, a physician working in Hollywood, Calif., write in the journal PLoS Medicine that while off-label drug use is “sometimes unavoidable” and sometimes “demonstrably beneficial,” it also has been linked to serious side effects.
Off-label drug use “should be undertaken with care and caution due to the uncontrolled experiment to which a patient is being subjected,” the physicians said.
In development, drugs may be promising for several uses, and companies must choose one or two conditions on which to focus research. If extensive off-label use is anticipated, a company may seek approval for just a narrow indication in order to speed a drug to market, Fugh-Berman and Melnick said.
Another technique is to use drug representatives, even though U.S. drug representatives are not supposed to detail doctors on off-label uses, the authors said.
The authors quote an article in Medical Marketing and Media in which a pharmaceutical industry attorney said: “Before engaging in off-label promotion, companies should ascertain the risk profile, safety, efficacy and potential commercial benefits of the use — without committing that last bit to print.”
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