Physicians have the authority to prescribe drugs for any reason they believe will benefit the patient, regardless of whether the use is on- or off-label. Off-label prescription is neither illegal nor unethical when based on the best available evidence.
By contrast, off-label promotion—unlike off-label use—has heretofore invited legal liability including criminal charges, penalties under the False Claims Act, and misbranding actions by the Food and Drug Administration (FDA). Opponents of off-label promotion argue that the off-label uses have not passed scrutiny by the FDA, the chief regulatory body charged with ensuring both efficacy and safety for specific indications of drugs.
In recent years, however, the trend toward heightened constitutional protection of commercial speech in the health care arena has opened up opportunities for off-label promotion without threat of liability. Proponents of both off-label drug promotion and expanded protection of commercial speech argue that, in an era of increasing transparency in health information, citizens have a right to know about any evidence that a drug might be effective for a particular off-label use.
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