What is Off-Label Drug Use?
Health Canada regulates drug products available to Canadians. Drugs manufactured and sold in Canada must go through a regulatory process to ensure their quality, safety and effectiveness before being approved for sale. In the case of Topamax, the drug has gone through the regulatory process and been approved for use as an anti-convulsant. This is considered the on-label use of the drug. This is also referred to as the drug’s indication. Health Canada has not yet approved this drug for use for other indications. The drug company must make a separate submission for approval for a different indication. When a doctor prescribes a drug for a use for which that drug has not yet been approved by Health Canada, that’s considered off-label use. The drug has already been approved for one use, for example, for epilepsy in the case of Topamax, but it has not yet been approved by Health Canada for use in other medical conditions. Is it allowed? Yes. There is nothing illegal about off-label drug use
Health Canada regulates all drugs sold in Canada. Before they are approved, drugs manufactured and sold in this country must go through a regulatory process to ensure their quality, safety and effectiveness. When a doctor prescribes a drug for a use for which that drug has not yet been approved by Health Canada, that’s considered off-label use. If a drug company wants to market a drug as a treatment for something other than for what it was originally approved, it must go through the regulatory process again. That can take years.
When a doctor prescribes a drug for a condition which it has not been approved for, this is known as off-label drug use. Around the world, off-label use is an accepted and common practice, especially in certain medical disciplines. At times, off-label use represents an innovative and fresh approach to a condition, while in other cases it reflects the standard of care and many years of customary use. In most cases, off-label prescribing is perfectly legal, although it may not always be safe for the patient. Before a drug is released, it goes through a lengthy testing and approval process. The drug is usually targeted at a specific condition, and the testing is designed to ensure that the drug is effective against the condition. During the approval period, the best doses and method of delivery are also determined. At the end of the testing period, the regulatory agency such as the United States Food and Drug Administration (FDA) will either approve or deny the drug application. Once appr
When the Food and Drug Administration (FDA) approves a new drug, it means the federal government has found the drug to be safe and effective for a certain disease or condition. The label information printed in the official prescribing information and in the package insert explains the use for which the FDA has approved the drug. It describes the approved dosage and way the drug should be given (pill, injection, infusion, etc.). In many cases, doctors – based on their knowledge and new information – may prescribe a drug for a use that is not listed in the approved labeling. The use of a drug for a disease that the FDA did not approve it for, or in a dose or by a route not listed on the label, is called “off-label” use of the drug. Off-label drug use is legal in the United States and in many other countries. But, drugs used off-label are only covered under Part D if the use is cited in one of the reference standards for prescription drugs (called a compendium) named in the new Medicare l
In the United States new drugs are tested in 3 phases of clinical trials (research studies) before they are approved for use in the general public. The clinical trials are done to prove that the drug effectively treats a certain medical condition, works the way it is supposed to, and is safe when used as directed. When the Food and Drug Administration (FDA) is satisfied that the drug is safe and effective, it works with the maker of the drug to create the drug label. This is not an actual label that sticks onto a container, but a report of very specific information. The FDA also must approve this report, which is made available to health professionals who dispense and prescribe the drug. The drug label contains information about the drug, including the approved doses and how it’s to be given to treat the particular medical condition for which it was approved. When a drug is used off-label, it is most commonly given for a different disease or medical condition than described in the FDA-
