FDA Considers Allowing Off-Label Promotion

Scott Kappes

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Reports have surfaced alleging that the FDA may be considering allowing pharmaceutical companies to market their drugs for uses other than those the drug was approved by the FDA to treat. This is known as off-label promotion. Doctors are allowed to prescribe a drug for whatever purpose they see fit; however, drug companies are not allowed to market drugs for treatments the drug was not approved for. Many drugs are commonly used to treat off-label ailments and off-label prescription has become common place, but we should be very concerned if the FDA allows big pharma to start deciding what their drugs can and should be used for.

This summer Cephalon was accused of off-label marketing of their pain medications Fentora and Actiq. Four deaths were attributed to off-label use of Fentora. Antidepressants are not approved for use in children, but a few years back thousands of children were being prescribed strong antidepressant drugs Paxil, Zoloft, and Prozac; that is until a study was released linking adolescent suicide to antidepressants. It turns out that clinical trials suggested this connection but were concealed by the manufacturer.

Although it is common for drugs to be used for off-label treatments I think it would be extremely detrimental to the consumer to allow drug companies to promote these uses. Each person may react differently to the same drug, what works like a charm for some could have grave consequences for another, allowing drug companies to market off-label would only increase the likelihood and frequency of adverse reactions.

For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.