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Sorry, I do not quite follow. FDA regulates the marketing of drugs, biologics, medical devices, etc. They do not regulate the practice of medicine. Your docto
by pfisherman 3y ago
Sorry, I do not quite follow. FDA regulates the marketing of drugs, biologics, medical devices, etc. They do not regulate the practice of medicine. Your doctor can prescribe whatever they want “off label”.
So for example, manufacturers cannot market erbitux as a cure for migraine headaches because no sponsor has submitted an application to FDA with compelling evidence that it is safe and effective for that particular indication. However, your doctor can still prescribe it for migraines if they so choose. Whether your insurance will pay for it is a different story.
- AnthonyMouse 3y ago> Your doctor can prescribe whatever they want “off label”. They can prescribe a drug which is not FDA approved, can they? You also have the question of which drugs need a prescription or are considered a controlled substance, which is certainly government regulation regardless of whether or not the regulatory agency is the FDA.
- pfisherman 3y ago> They can prescribe a drug which is not FDA approved, can they? Yes they can. They can give you whatever medical advice or prescribe whatever regimen they want. They could tell you to drink bleach and the FDA would be powerless to do anything about it. I think the strongest argument for you would be a drug approved in another country; but not in the US. Your doctor can still prescribe it; and under the right conditions that prescription can allow you to obtain the drug in a foreign country and bring it back to the US. https://www.fda.gov/consumers/consumer-updates/5-tips-traveling-us-medications https://www.fda.gov/consumers/consumer-updates/5-tips-travel...