... Off Label ...
Is off-label drug use legal?
The off-label use of FDA-approved drugs is not regulated, but it is legal in the United States and many other countries. An exception to this is the use of some controlled substances, such as opioids (pain medicines like morphine and fentanyl). These drugs cannot legally be prescribed in the United States except for approved purposes.While it’s legal for doctors to use drugs off label, it’s not legal for drug companies to market their drugs for off-label uses. Off-label marketing is very different from off-label use.
Why are drugs used off-label?
Older, generic medicines are the ones most often used off label. New uses for these drugs may have been found and there’s often medical evidence from research studies to support the new use. But the makers of the drugs have not put them through the formal, lengthy, and often costly process required by the FDA to officially approve the drug for new uses.Off-label drug use is common in cancer treatment because:Some cancer drugs are found to work against many different kinds of tumors.Chemotherapy treatments often combine drugs. These combinations might include one or more drugs not approved for that disease. Also, drug combinations change over time as doctors study different ones to find out which work best.Cancer treatment is always changing and improving.Oncologists (cancer doctors) and their patients are often faced with problems that have few approved treatment options.Oncologists and their patients may be more willing to try off-label drugs than other medical specialties.