Off label uses of medications

[Pacman]

Are doctors legally allowed to prescribe medications for off label uses if they sincerely believe that there is a medically justified benefit for the patient? If they can, are there any substance and/or dosage restrictions/limitations?

I understand that the answer is probably highly dependent on the type of medication and what the condition is, but is there a general consensus on what is allowed and what is not allowed? Or are there many gray areas?

I would assume on the level of pure medical ethics this would be more than okay to do (medical benefit for the patient = medically ethical), but I'm really just asking from the legal and regulation aspects.

 

[CoastWatcher]

Here in Canada it is legal and, from what I understand, it is in the States as well.

 

[captq]

My Endo said no to HCG citing the off label use as in his words illegal to prescribe and illegal for the pharmacist to dispense. It was like I was asking for oxycontin for a papercut.

To complete the logic chain I asked what about Revatio for ED and he said exactly no way that's illegal that is an off label use. I think the drug rep has him drinking the cool aid.

 

[CoastWatcher]

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/

A nice, concise abstract explains that off-label use in NOT illegal in the US. It is liability, a law suit, that doctors fear. They use the "illegal" as an excuse to avoid it.

 

[Nelson Vergel]

Many medications are prescribed off label legally. Nothing wrong with it as long as there are studies the doctor can refer to if they ever get audited. Of course, this does not apply to schedule 2 drugs.


In the United States, no law prohibits a physician or other healthcare practitioner from prescribing an approved medication for other uses than their specific FDA-approved indications. Pharmaceutical companies are not allowed to promote a drug for any other purpose without formal FDA approval. Marketing information for the drug will list one or more indications, that is, illnesses or medical conditions for which the drug has been shown to be both safe and effective.

In our field TRT+ HCG, anastrozole, clomiphene, tamoxifen, and other drugs are commonly prescribed even though they have not been approved for their respective use in men.