A seemingly simple question is actually pretty complicated.
Let me start with a few basic general principles of FDA drug and state law.
First, after a drug is approved for marketing under an NDA (New Drug Application), the drug manufacturer can only advertise its FDA-approved labeled indication. However, as far as federal law goes, physicians can prescribe almost any drug for any purpose, (subject to state law standard of care issues which I will talk about in a bit).
This principle was established in the early 1980s in the case involving the father of a good friend of mine. U.S. v Evers. The FDA tried to stop CAM (complementary and alternative medicine) doc, Ray Evers, from using Chelation Therapy beyond its FDA-approved use (acute lead poisoning). The Fifth Circuit held that Ray Evers was practicing medicine and the FDA did not have the statutory authority to regulate or interfere with that, because the practice of medicine is a matter of state law. Here is the decision. https://openjurist.org/643/f2d/1043/united-states-v-h-evers-m-d-h
(The only federal statutory exception to this general FDA rule is that HGH (Human Growth Hormone) can only be prescribed for 5 medical conditions (3 in children and two in adults). That came about in an amendment to the Controlled Substance Act in 1990. Prescribing beyond those 5 indications is a federal felony. In the ’90s and early 2000s, there were a number of physicians who lost their medical licenses for off-label prescribing of HGH. But that doesn’t happen so much now for a few reasons. (And I don’t see the point in going into this any further).)
It is true that the federal government authorities, namely the CDC and the FDA have strongly discouraged the use of the off-label use of these drugs, but per the above, neither federal agency has the direct power to enforce their opinions. On the other hand, the pronouncements of these agencies can have a very strong indirect effect, in particular with the state agencies which do have the authority to limit access to these drugs, and take action against those health care professionals who continue to provide patients access to the see drugs. That would be the state medical and pharmacy boards.
Very recently a group of doctors has filed a lawsuit against the FDA for in effect interfering with their ability to practice medicine and exceeding their statutory authority in doing so. Seems like a good lawsuit. The feds will move to dismiss for failure to state a claim. We’ll see what the district judge does. Here is the complaint. 01-Complaint-without-ExsThe case is being handled by a high-power DC guy who used to be white house counsel to the first President Bush. I hope the case survives dismissal.
But getting back to state law:
In some states, it is difficult to get a prescription filled for Ivermectin or HCQ. It is well-known that one Maine physician got her medical license summarily suspended for writing scripts for these meds and lying about the reason for the script. Doctors in states which frown on the off-label use of these treatments have developed some tricks to lessen the risk that state boards will discover their prescription writing.
Notice that we are talking much about physicians and what they can do and whether they might get into trouble, and that is because the right of patients to get these off-label prescription drugs is obviously inextricably tied up to a physician’s ability to prescribe these medications without undue risk to their medical licenses. Based on the FDA’s and the CDC’s views, which have been adopted by the mainstream medical professional organizations (just recall the medical organizations which suppose the AB 2098 covid misinformation bill), it is clear that prescribing these drugs off-label is not within the standard of care.
But that is not the end of the story because in some states physicians are given the right to practice non-mainstream medicine, which is usually called either complementary and alternative medicine or integrative medicine. Functional medicine and homeopathy would be other forms of alternative medicine. And of course, naturopathic medicine would be included, but in California (and a couple of dozen other states) naturopathic physicians are recognized and have their own boards. (So I won’t be including licensed naturopathic medical doctors in this analysis.)
I have litigated these alternative medicine cases in many states over the last few decades. Texas has the best law (actually a board policy which has been added to the state administrative code (Chapter 200)). New York has a sentence dealing with nonstandard of care in its board law. Washington had (and I think still has) a provision, but that provision was so bad that I elected to proceed under the regular standard of care (when that version of the law was in effect back in the mid-1990s. More recently, again I used the regular standard of care (and got a defense verdict in a board case).
Turning to California, it does have a CAM statute Bus. & Prof. Code Section 2234.1. Here it is if you want to look it over.https://codes.findlaw.com/ca/business-and-professions-code/bpc-sect-2234-1.html
On its face, this statute it might appear to allow physicians to provide either HCQ or Ivermectin to patients with proper informed consent. However, there are no published Court of Appeal or Supreme Court decisions interpreting or applying this safe harbor provision (which was passed around 2005, largely because of the late and great health freedom advocate Frank Cuny).
Those who read my blog know I raised the issue recently in the medical exemption context. However, both the ALJ and the Superior court judge found the law inapplicable for a couple of reasons, including because the risk of not vaccinating outweighed the potential benefit to the children who had the medical exemptions. This risk-benefit analysis led the courts to conclude that providing these medical exceptions was not covered by the 2234.1 safe harbor. (Take a look at the definitional section in the law which is linked above).
Besides the two successive judges in the Board case, the Section 2234.1 issue was argued to a couple of other Superior court judges in special proceedings involving medical records. Those other judges agreed with these two.
Reluctantly, that leads me to think that in the vaccine and pandemic context, the Medical Board and the California courts may not give physicians the same discretion to provide CAM treatments or advice, as say with other CAM modalities, say functional medicine, or for other non-pandemic diseases or medical conditions. AB 2098 if passed, would be another indication that the Board won’t look kindly on doctors who write these scripts. (I explained this more in my previous post.)
But the only way we are going to know for sure is by seeing how this plays out if the Board goes after physicians for writing these off-label scripts for Covid. As I have said before, California medical doctors writing these kind of prescriptions should be very careful.
There has been no direct legal challenge by California patients asserting a right to utilize these treatments. That might be an interesting thing to explore. This kind of challenge by patients, like the Texas lawsuit discussed above, would challenge the FDA’s action as well.
If patients do have a right to take a prescription drug off-label with informed consent, even if such use is not within the standard of care, that would seem to imply that physicians have the legal right to write such prescriptions without violating the standard of care.
But like I said, I don’t think there is any absolutely on-point authority on this issue.
The closest case on the issue of a patient’s right to take a treatment which is not consistent with the standard of care may be a case my former law firm handled and made new law on a few decades ago. It was a civil case, not a medical board case.
But here is what the Second Circuit Federal Appeals Court said about patients’ rights to take the treatment of their choice, and that treatment was not even FDA approved!
“We see no reason why a patient should not be allowed to make an informed decision to go outside currently approved medical methods in search of an unconventional treatment” because that is “within the patient’s right to determine what shall be done with his own body.” Now those were judges who knew what was right!
The case is Schneider v. Revici decided in 1987. Here is the link to the decision. https://www.casemine.com/judgement/us/59148ca5add7b04934535d57 .
This story behind this case and our firm’s defense of medical maverick cancer doc Emmanual Revici is the first chapter in Galileo’s Lawyer . You may find the story interesting and even relevant to some of the issues we are facing today, so here is a pdf of the chapter. (warning it’s pretty irreverant).
Maybe it’s time for the patients to get involved in these standard of care issues. Just putting it out there.
Rick Jaffe, Esq.