Many of you tuned into the recent oral argument in the physicians’ lawsuit against the FDA. The bone of contention? Alleged interference with the practice of medicine due to the FDA’s statements (and tweets) against using Ivermectin for Covid. And who could miss that provocative and heartening recent headline in Epoch Times: “Doctors Can Prescribe Ivermectin for COVID-19: FDA Lawyer”?
If you missed it, catch up here:
Now, to all the doctors who’ve been rubbing their hands in glee, thinking they can now freely prescribe Ivermectin for Covid without any repercussions, hold your horses 🐎 because if you had paid close attention to the judges’ questions, you’d know why. For those who missed the memo, I will explain, but I want to give some history, background and context so we’re all on the same page.
The FDA is tasked with approving drugs, biologics, and medical devices for interstate marketing and also gives the green light to clinical trials testing these products. Due to financial constraints, drugs and devices are usually approved for one specific indication or use. Once a drug gets the NDA (New Drug Application) stamp of approval, it can be legally marketed interstate. Manufacturers can promote the drug, but only for its approved use.
However, once a drug has NDA approval, physicians can prescribe it for any purpose. This is known as “off-label” use or prescribing, which is a very common practice.
The journey of off-label use typically starts with a few daring physicians trying the drug on patients who haven’t responded to FDA-approved treatments for the specific condition. Sometimes these doctors document their results in published case studies, or they just tell their fellow doctors about their success. Other physicians then try out the off-label treatment, and on it goes. Sometimes, there are studies on the off-label use, but often it’s just word of mouth or through physician meetings, local then regional and then national. At some point, the off-label use becomes recognized as the standard of care for a condition, even if the FDA hasn’t given it the official nod. Manufacturers can apply for additional uses, but that is very pricey. And with drugs having a limited patent life, it is usually not worth the coin to do so. And that is why many off-label drugs which are used within the standard of care never receive formal FDA approval.
Ray Evers vs. The FDA
In the swinging ’70s, the FDA believed it could regulate or even prohibit physicians from using certain drugs off-label, if it chose to do so. Its main target? EDTA/chelation therapy, an FDA-approved IV drug for acute heavy metal toxicity.
Enter Dr. Ray Evers, the poster child of alternative health clinics in the ’70s and a staunch advocate of EDTA chelation therapy for heart disease. This method was cheaper and less invasive than standard treatments, and that my friends is the surest way for a doc to get into trouble in this country. (Hey, I don’t claim to be a completely disinterested reporter.) The FDA, probably carrying the water of big Pharma and conventional heart doctors, (see previous sentence) tried to shut him down.
Mike’s Dad stomps on the FDA!
An Alabama district judge ruled that Ray’s use of the FDA-approved drug was the “practice of medicine,” and the FDA had no say in it. This decision was groundbreaking. The Fifth Circuit upheld the result, albeit on narrower grounds. For those who love the legal weeds, check out the decision here.
US v Evers 643 F2d 1043 5th Cir 1981
(I have a personal connection to Ray’s case. His son, Mike Evers worked on the case and is a long-time close friend and fellow health freedom warrior.)
Since then, the FDA has mostly steered clear of directly regulating/putting its thumb on the scales in practice of medicine issues, except for a few hiccups like the Ivermectin and HCQ debacle.
Who’s the Boss of “Practice of Medicine”?
Simple: state medical boards. They regulate the “practice of medicine” by enforcing the “standard of care.” This standard reflects the majority consensus in a particular medical community or specialty. Medical boards determine this standard mainly through disciplinary actions against doctors who allegedly violate it. Occasionally, the medical boards adopt policy statements or guidelines on specific issues.
Doctors are presumed to know the standard of care, which to me is a dubious proposition for many reasons, but that is a topic for another time.
Connecting the Dots: Ivermectin, the Fifth Circuit Case, and the ET Article
The long and short of it is that state medical boards, not the FDA, regulate the practice of medicine. They decide if the use of Ivermectin and other off-label drug use aligns with the standard of care. So, an FDA attorney’s acknowledgment that doctors can legally prescribe these drugs (under federal law) has ZERO RELEVANCE in determining if a doctor can be prosecuted and sanctioned by a state medical board for prescribing these drugs for Covid.
Big picture wise, it’s a matter of federalism, i.e., the division of responsibilties between the federal and state governments, and the law is very clear here on who calls the shots. Of course, there are other important issues in this federal case, like whether the FDA has the power or should exercise it in speaking out as it did. But frankly, it’s complicated and beside the point of this post.
So, dear doctors, if you think the FDA attorney’s statement or the ET article grants you a free pass/legal immunity to prescribe these drugs for Covid, sorry to burst your bubble, think again.
Stay informed and stay safe!
Rick Jaffe, Esq.