Off-label prescription of a drug is generally legal; some drug companies are using techniques to covertly promote off-label drug use, even when such promotion is illegal, according to an article in this week’s PLoS Medicine.
Adriane Fugh-Berman, MD, from Georgetown University Medical Center in Washington D.C., and Douglas Melnick, MD, a preventive medicine physician working in North Hollywood, Calif., wrote that while off-label drug use is “sometimes unavoidable” and sometimes “demonstrably beneficial,” it has also been linked with serious side effects. Off-label drug use, they said, “should be undertaken with care and caution due to the uncontrolled experiment to which a patient is being subjected.”
Yet, drug companies have a stake in promoting such off-label use, since increased off-label use means “larger revenues from larger user populations, especially for products with narrow indications,” the authors wrote.
Both Melnick and Fugh-Berman outlined some of the ways that drug companies can promote such off-label use, such as decoy indication.
In development, Fugh-Berman and Melnick said drugs may be promising for several uses, and companies must choose one or two conditions on which to focus research. Ease of approval is the most important factor in this decision. If extensive off-label use is anticipated, a company may seek approval for just a narrow indication to speed a drug to market. Therefore, a drug may be approved for this very narrow decoy indication while an extensive off-label campaign is not disclosed to drug regulators.
Another technique is to use drug representatives, even though in the U.S. drug reps are not supposed to detail off-label uses to doctors.
The authors cited an article in Medical Marketing and Media, in which a pharmaceutical industry attorney wrote: "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". In other words, that illegal promotion may be cost-effective if potential profits trump potential fines, Fugh-Berman and Melnick said.
Pharmaceutical marketing has "distorted the discourse on off-label uses and encouraged the unmonitored, potentially dangerous use of drugs by patients for whom risks and benefits are unknown,” they added.
“Companies that engage in off-label promotion should be heavily fined and their future marketing practices subject to increased scrutiny by regulatory agencies,” they wrote.