The FDA wants to regulate the practice of Medicine
After everything that has come to light, do you want them to have this kind of power?
For those who have been paying attention to the regulatory apparatus in recent years, you may remember quite a bit of noise concerning the use of generic drugs for the treatment of a certain respiratory infection.
Basically, the biomedical industry told us to sit at home until they could release a series of experimental drugs which, by any reasonable standard, would not have met safety or efficacy thresholds for commercial distribution let alone coercion.
They were able to do this because the WHO had declared a Public Health Emergency of International Concern (PHEIC), and this provided the basis by which the FDA could start pumping out unproven experimental drugs under the label of an “Emergency Use Authorization.”
First it was PCR tests, then Remdesivir, then it was gene-therapy, and finally they moved onto novel ‘early treatment’ options like Paxlovid.
They even have a catchy commercial for it:
Bit of Background
With respect to the practice of medicine, the FDA has the responsibility of assessing whether new drugs or devices meet the regulatory standards to be used in licensed practice.
For example, a New Drug Application will be submitted to the FDA (by a pharmaceutical company) for the ability to market this new drug in the commercial sector.
The FDA, in theory, would review the applicants documentation supporting the approval of the drug and make a judgement about a few important factors. For our purposes, the FDA will determine if the drug is safe for public consumption and if the the drug is effective for the purposes that the manufacturer intends to claim.
Hence the popular catchphrase, Safe and Effective™.
For the practice of medicine, one of these FDA functions is more important than the other. If you haven’t guessed it - it’s safety. As you may know, effectiveness can be in the eye of the beholder.
What is effective for one person may not be for another. Effectiveness also varies by indication. What exactly are we trying to treat? One drug can, and often does, have multiple effects. Which means there are multiple potential targets the drug can be used for.
For example, for patients with PCOS (polycystic ovarian syndrome) metformin can be used as a fertility aid (even though it is typically used as a medication for diabetics). The practice of using an FDA approved medication for something other than the commercially approved indication is called off-label.
Off-label use of FDA approved medications is very common, and by the FDA’s own admission accounts for up to 30% of prescriptions. As it should be.
The job of the physician is to know what tools are available for him to use, and how best to use them.
This is what clinical expertise is for.
If there is a tool which is effective for the problem at hand, we need not wait for the FDA to amend the NDA to include that problem. After all, these ‘labels’ are only for what the manufacturer desires to claim on commercial documents.
What’s the Big Deal?
This article from the Wall Street Journal may be interpreted as rather sensationalist.
The author states that the 4000+ page Omnibus Appropriations bill soon to be signed by Biden includes a 19-line section that stands to give the FDA more control over ‘how doctors practice medicine.’
Specifically, the new legislation would amend the Food, Drug and Cosmetic Act (FDCA) to give the FDA the power to ban off-label use of devices. Admittedly, this is specific to a ruling that occurred in 2020, in which the FDA banned the use of an electronic stimulator device for a specific indication.
You may think that this is rather innocuous and idiosyncratic - not to be blown out of proportion.
However, there is a provision in the FDCA which prevents the FDA from regulating the practice of medicine.
Now, if the FDA were a forthright organization that made decisions solely for the benefit of Americans - then I would agree with you. In such a fantasy scenario, we shouldn’t make too much of this amendment.
However, we live in the reality in which the FDA:
has unbelievable conflict of interest with the industry it is meant to regulate
withdraw approval or add black-box warnings to a large proportion of products they thought were Safe and Effective™
Only after allowing the manufacturer to make billions of dollars over years to decades
more recently, have decided to play favorites and promote drugs under emergency use authorization in place of drugs that have been used for decades, with some of the best safety profiles in existence…
This is the same FDA that continues to promote using ineffective, harmful, experimental gene-therapy for infants as young as 6 months old!
Who among you believe that the FDA is not in the pocket of the medical industry?
Who among you believe that, once the FDA is given the power to ban off-label use of a product freely available on the market, it would not abuse this power?
Who among you are certain, that once such a precedent is set - the FDA’s benefactors (AKA big pharma and biotech) wouldn’t strong-arm them into banning off-label use of generic drugs so that doctors would be forced to prescribe newer, more expensive, and less well understood alternatives?
Just look at what our regulators have done to antagonize use of something as benign as vitamin D, and as commonplace as hydroxychloroquine or ivermectin…
Not only that, but our medical boards threatened and revoked the medical license of doctors who prescribed safe drugs for off-label early treatment of covid.
Pharmacies stopped fulfilling prescriptions written by real doctors.
By now, you may have gathered that the omnibus bill within which this amendment lies is most likely going to be put into action. All that is left is for Biden to sign it.
I highly doubt that Biden would back out of this money-printing bill after it’s made it to his desk.
Over the last 2 years every time I have thought to myself:
Surely, they wouldn’t go that far?…!
Shortly thereafter, they do.
At this point, I am just preparing myself for the inevitable.
So should you.
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Doc, in the meanwhile, Ontario (Canada) are working on accelerating med school training.
"Shorten the time to get into medical school.
Shorten the duration of medical and nursing training.
Shorten residencies (post-graduate hands-on learning; like an apprenticeship)."
Do you see this model getting replicated in other parts of the world?
So, the question is, what are we to do?
I sincerely doubt my state senators or rep care about this provision hidden away in the bloated bill.
What recourse do we have?
I am sick and tired of the F D A doing everything that is opposed to decent human compassion, everything that does good only for the pockets of the pHarma companies.
Pretty soon we will lose all the old generics that have reasonable track records, because the big companies will demand use of only their latest and greatest inventions. I present Coumadin as but one example. Why is it no longer available?