"Off-label" Drug Use and Marketing

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Prescription drugs are approved by the Food and Drug Administration for specific uses (or indications) to treat specific conditions or diseases. Physicians may prescribe a drug for a use that’s not described in the approved labeling if it seems reasonable or appropriate to them. This is what’s called “off-label use.” For example, it is not uncommon for physicians to prescribe low doses of beta blocker drugs to help people overcome jitters before public speaking. Beta blockers are not formally approved for this use. The FDA advises doctors in such circumstances that “they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects.”

A study in the Archives of Internal Medicine found that about 21% of all estimated uses for commonly prescribed medications were off-label, and that 15% of all estimated uses lacked scientific evidence of any useful or beneficial effect. The authors concluded that “policy makers must begin to consider strategies for mandatory postapproval surveillance that focus on curtailing underevaluated off-label practices that jeopardize patient safety or represent economically wasteful prescribing practices.” Put another way, they recommend more careful monitoring of off-label uses that might waste money and harm patients.
Another important consumer issue regarding “off-label” prescribing is the fact that some insurance plans will not reimburse the cost of drugs prescribed for “off-label” use.

But while “off-label use” is permitted, marketing of a drug for an “off-label use” is not.
Perhaps the best known case of the dangers of off-label marketing is that of the drug Neurontin. Journalists and consumers should be aware of the potential pitfalls of “off-label” prescribing and should be wary of claims made for products being used “off-label.”


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