September 26, 2016
False or misleading product claims
Termed ‘off-label marketing’, suppliers can market a product to healthcare providers outside the uses for which it has been approved by regulators and what is stated on the product label. This can be extremely profitable for suppliers, as increased use of their products will generate more revenue. A healthcare professional may prescribe off-label, for example, to patients in a different age group to those a product was tested on, to prescribe a different dose or duration, or to use a different mode of administration. This is extremely common for population groups that are often excluded from clinical trials, such as pediatrics or geriatrics.
Off-label marketing is an issue for many regulatory authorities. In the US, off-label marketing has resulted in large fines by the Department of Justice using the False Claims Act. In other parts of the world, this behaviour often can go unchallenged.
Off-label marketing can be dangerous for patients if the unapproved use that is promoted has not been shown to be safe and effective using robust evidence. There are also concerns that if the bar were lowered to allow such marketing practices, this would obviate the need for large scale clinical trials to get a drug approved by the regulators.