What is the law regarding the off-label use of drugs?
In California, the law regarding off-label drug use is a complex one. Off-label drug use is the practice of prescribing, dispensing, and administering a drug for a use or indication other than the one approved by the U.S. Food and Drug Administration (FDA). It is important to note that off-label uses of drugs can be beneficial and can provide needed treatments to patients when an FDA-approved drug is not available or is not effective. Under California law, a physician may prescribe and administer an off-label drug to a patient as long as the physician is acting in accordance with an accepted standard of care. However, the physician must also make sure that the patient understands the potential risks and benefits of the off-label drug that are not included in the FDA-approved labeling. The physician must also document that the off-label drug is a medically appropriate treatment for the patient’s condition, in addition to any other medical information. It is also important to note that California law does not allow drug manufacturers or distributors to promote or advertise off-label uses of their drugs. Furthermore, health insurance companies may not deny coverage of off-label drug use when it is medically appropriate and the off-label use is supported by scientific evidence. To summarize, California law allows for off-label drug use as long as a physician is acting within an accepted standard of care, the patient is informed of the potential risks and benefits, and appropriate documentation is kept. Additionally, drug manufacturers and health insurance companies may not deny coverage when off-label drugs are medically necessary.
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