Hidden truth: The perils and protection of off-label drug and medical device promotion.

What can you do if you learn you have a life-threatening illness but there is no Food and Drug Administration-approved medicine to treat it? Sometimes, there is nothing to do but hope. Very often, though, your doctor will be able to prescribe a drug or medical device that has been approved by the Food and Drug Administration (FDA) for a different condition. This practice, called “off-label” prescribing, is perfectly legal, commonly practiced within the medical community, viewed as an essential component of good medical care, and offers greater choice in treatment options for millions of American patients. It is not without controversy, however. Because the safety and efficacy of off-label uses have not been certified by FDA, some in government and the public health community have long criticized the practice. And FDA has long forbidden drug and device makers from disseminating most information about off-label uses, often making it difficult for doctors and their patients to learn about important therapeutic options. No federal statute explicitly forbids manufacturers from promoting or otherwise disseminating information about off-label uses of their drugs and devices. FDA has, however, extended its authority over product labeling to encompass manufacturers’ speech in other contexts—including print and broadcast advertisements, brochures