Free Speech for Big Pharma: ‘Off-label’ drug promotion saves lives. So why does the FDA forbid it?
One of the most important elements of medicine is also among the least well known: the ability of physicians to prescribe approved medicines for purposes not sanctioned by the Food and Drug Administration. These so called “off-label” uses are perfectly legal, and doctors rely on them extensively. But in a number of ways, regulators make it difficult for doctors to learn about and prescribe drugs off-label; one such way is a rule that forbids manufacturers from promoting such uses. That might change soon. Two federal courts are now considering lawsuits that challenge the constitutionality of the off-label promotion ban.
Before a drug can be sold in the United States, it must be certified by the FDA as safe and effective for a specific, or “on-label,” use—to treat high blood pressure or a certain kind of leukemia, for example. However, once a drug has been approved, physicians may legally prescribe it for any other purpose. And because medical research reveals treatment successes long before a new use can work its way through the lengthy FDA approval process, off-label prescribing enables patients to benefit from the most up-to-date medical knowledge.
The practice is ubiquitous in a number of medical specialties and, by some estimates, at least 20 percent of all prescriptions written are off-label. Naturally, off-label prescribing must be done judiciously because “guesses” about possible uses of drugs may have deleterious results, as illustrated by a recent safety review of the heart drug Multaq (also known as dronedarone).
According to a December 2011 announcement by the FDA, although the drug reduces the likelihood of hospitalization in patients who have had transient atrial fibrillation (an abnormal heart rhythm)—which is the approved, on-label, use—the drug increases the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation. That means doctors must continuously gather information about the risks and benefits of all the medicines they prescribe, for both on- and off-label uses.