Under the FDCA, the FDA is banned from regulating the practice of medicine – however, Section 360f allows the FDA to ban the use of “off label” medical devices = regulating the practise of medicine
The FDCA is described here:
Federal Food, Drug, and Cosmetic Act (FD&C Act) | FDA
“The Federal Food, Drug, and Cosmetic Act and subsequent amending statutes are codified into Title 21 Chapter 9 of the United States Code.”
Interesting articles covering this continued overreach of the FDA here and here:
The FDA Wants to Interfere in the Practice of Medicine - WSJ
Commented on this tweet by Dr Makary of Johns Hopkins (medical professor and National Academy of Medicine member)
It rather begs the question “is the banning of off-label devices the equivalent of practising medicine?”
Seems to me that – provided off label use is beneficial to treatment and no malfeasance liability arises – banning a proven cure is a medical intervention.
What is even more egregious is that no debate was allowed in Congress because of the usual tactic of submitting a 4,155 Omnibus Bill and burying significant legislation on page 3,542.
This is no way to run a representative democracy for any country and stinks to high heaven.
“Doctors are speaking out against a new law that arguably paves the way for the FDA to prohibit treatments for purposes it hasn’t expressly authorized, going far beyond highly politicized subjects such as treating COVID-19 with ivermectin,” Just the News reported this week.
Not just ivermectin: New FDA authority to ban off-label uses alarms doctors | Just The News
Onwards!
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FDA' sought power-status (covering any/all drug prescribing) seems to be a precursor to that certain persons in power have the means to dictate how and which conditions to treat. Med- doctors will be their civil servants and patients will be their lab-rats.What occurred during 2020 -23 will in the future be the norm. It is a precursor to the WHO treaty.
This will result in an astronomical increase in the cost of medical research and therefore an astronomical increase in the cost of drugs and devices and delay in availability.
Currently if there are two or more disorders that could be treated with a drug and one is common and the other is relatively rare you do the research on the common disorder because it is easy to get enough patients to study. If the drug is approved, the doctors know that they can cautiously use it for the other less common conditions with the same pathophysiology. and additional studies will follow. It gets used and published and becomes standard of care. Safety studies do not need to be done separately because you already established that with study of the first disease and by the time that its use in the second disease become SOC you have even more safety tested by its use in the first disease.
If FDA chooses to do this they will have to do studies on each and every disease for which the drug can be used thus taking more time and money - resulting in the drug being more expensive and delaying availability.