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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.

William
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  • Possible duplicate of Off-label prescribing of drugs – Chris Rogers Oct 16 '18 at 15:31
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    @ChrisRogers aren't off label prescriptions and drugs not approved at all by the FDA different? – William Oct 16 '18 at 15:44
  • This leads me to believe prescriptions not approved in the US may be refilled under extremish circumstances http://thehealthcareblog.com/blog/2013/08/26/should-a-doctor-prescribe-drugs-that-are-unapproved-by-the-fda/ – William Oct 16 '18 at 15:52
  • @William You can get virtually anything by purchasing online, but I don't believe a doctor can legally prescribe any drug not FDA approved except as part of a clinical trial. As the author of the article noted, doing so would likely be seen as malpractice if the patient suffered any harm. – Carey Gregory Oct 16 '18 at 19:10
  • A complete answer is going to depend on what, exactly, the drug is, and what you mean by "can", "prescribe", and "off limits". An order to a pharmacy is only necessary for things that require it, i.e., things that are determined to be dangerous outside medical supervision. I can recommend any number of things that a patient can get on their own, but don't require a prescription in order for it to be dispensed. – De Novo Oct 16 '18 at 23:49
  • @DeNovo I am talking about prescription drugs hence the prescription tag. – William Oct 16 '18 at 23:50
  • So, then you're talking about investigational drugs? Some drug in particular? – De Novo Oct 16 '18 at 23:51
  • That clarifies things :) You might edit your question to include it. – De Novo Oct 16 '18 at 23:53

2 Answers2

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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.

Bryan Krause
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@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.

De Novo
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