Medical Sciences Stack Exchange is a question and answer site for professionals in medical and allied health fields, students of those professions, related academics, and others with a sound understanding of medicine and healthcare-related sciences. It only takes a minute to sign up.
Sign up to join this community
There are lots of both prescription and generic drugs that are not approved at all for any reason in the United States.
Some of this I have gathered is do to funding and historical reasons they were not approved and not necessarily because they are unsafe.
Can Doctors in the United States prescribe these drugs because they are in a grey area or are they off limits?
An example drug that I might be referring to is Solian. Australia has it approved and parts of Europe yet not the US or Canada.
The FDA regulates manufacturers of drugs, not physicians, with respect to the drug approval process.
US law does not prevent physicians from prescribing unapproved substances (presuming they aren't illegal for some other reason), as long as it is not done for unapproved research.
That said, physicians may be restricted by local laws, professional organizations, their employers, and exposures to liability. It also isn't legal for a manufacturer to market an unapproved drug in the US, so simply obtaining an unapproved drug may be difficult.
For Solian, for example, it is marketed and approved in Europe, but the manufacturer isn't going to ship any to the US (doing so would likely run afoul of the FDA), no pharmacy is going to stock it, etc, so having a prescription won't do much good, and anyone who would be willing to ship it probably would not care whether or not you have a prescription in the first place. Therefore, a physician wouldn't have much purpose in writing a prescription for it rather than one of several similar drugs available in the US.
@BryanKrause's answer is correct. To add a little more, rules and regulations for physicians are primarily set by the state medical board and state legislature. States are different in the particulars, but you can make some general statements. Generally, if the treatment is intended to benefit the individual patient, there is informed consent (the unapproved status of the drug is discussed with the patient), and the physician can point to a sound scientific basis for choosing that particular drug, and everything is appropriately documented, there shouldn't be a license issue. There may be a liability risk, though. Personally, I'd be uncomfortable doing it without a compelling reason.
The specific drug will make a difference. If it is illegal or has been pulled from the US market or denied approval due to safety concerns, I don't think a conscientious and professional US physician would recommend it. Regarding solian, an atypical antipsychotic, with good evidence of safety and efficacy, I'm not a psychiatrist, but I could see a possible case where a patient is stable on solian. Here, the psychiatrist might recommend continuing solian, IF the patient has access and is able to purchase the drug from a reliable source with good quality controls. These are major challenges, though. I don't think being able to purchase it on the internet would necessarily satisfy them. Given so many approved atypical antipsychotics, though, I would have a hard time imagining a case where a US psychiatrist would start a patient on solian.
