In a sneaky move, the FDA has extended its power over how doctors can practice medicine. Action Alert!
Doctors, be advised: the FDA is starting to regulate the practice of medicine. Buried in the 4,155 page spending bill Congress recently approved is the innocuous-sounding “Bans of Devices for One or More Intended Uses.” This dangerous provision allows the FDA to ban off-label uses of medical devices while leaving them approved for other uses. This provision expands the FDA’s power to dictate what your doctor can and can’t do. Today, it’s medical devices, but the FDA could easily use this as a precedent to further expand its power to regulate the practice of medicine and enforce a one-size-fits-all vision of medicine.
Off-label use of medicines and medical devices is a critical component of medicine. One in five prescriptions written are for off-label use—that is, when a doctor gives you a medicine approved by the FDA to treat a condition different than yours. Hundreds, if not thousands, of drugs are commonly prescribed for off-label uses. Here are some common examples. This is completely legal. The Food, Drug, and Cosmetic Act prohibits the FDA from limiting or interfering “with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease.” In simple language, the FDA is not allowed to interfere with the practice of medicine.
Off-label use of medical devices is also common, especially in pediatric populations, pregnant women, cancer patients, and patients with rare diseases, since companies are often not willing or unable to sponsor clinical trials to support claims for those uses. Pediatric off-label use of medical devices includes dilation balloons for pulmonary artery stenosis and valvar aortic stenosis, cutting balloons for pulmonary artery stenosis and creation of atrial septal defect, and radiofrequency perforation wire for perforation of atretic pulmonary valve.
The FDA’s role is to control which medications and devices are commercially available, not to limit or control how they are prescribed by physicians once the medications are on the market. A commentary in the Wall Street Journal encapsulates how important this is:
Off-label use enables physicians to assess their patients’ unique circumstances and use their own evolving scientific knowledge in deciding to try approved products for new indications. If the treatment proves useful, formal studies are performed and published. If enough evidence accumulates, the treatment becomes the standard of care, even if the manufacturer didn’t submit the product for a separate, lengthy and costly FDA review.
Off-label use is what allowed front line physicians to experiment with different approved medications (like hydroxychloroquine and ivermectin) for the treatment of COVID—with documented success.
It’s worth noting how this all came about. The FDA asked Congress for this change after it was blocked in court from banning certain off-label uses of medical devices. The court held that the FDA could ban a medical device altogether if it poses “an unreasonable and substantial risk of illness or injury,” but banning an off-label use of an approved device is regulating the practice of medicine and therefor prohibited. The FDA violated the law, so the agency turned to Congress to change it.
While the current policy change applies only to medical devices for now, we believe it is likely that the FDA will use this as a precedent to gain similar power over the off-label prescribing of drugs. The agency can then use this power to further the interests of Big Pharma. Keeping with the COVID example, the agency could have banned the off-label use of hydroxychloroquine and ivermectin—two generically available drugs that aren’t big money-makers—in an effort to get more people to receive the vaccines. Remember, as we’ve said many times, the FDA sees Big Pharma as its client. If the agency gains the ability to ban off-label uses of drugs, it can use this power to give blockbuster drugs that are about to come to market a boost by banning the off-label competition.
Consider, too, that intravenous vitamin C (IVC) is an FDA-approved drug for the treatment of scurvy. Intravenous vitamin C is widely used in the integrative medical community for a variety of conditions. The FDA could easily ban all off-label uses of IVC to eliminate one more form of competition for Big Pharma’s drugs.
This is the latest in what is becoming an onslaught on your doctor’s freedom to practice medicine as they see fit. We’ve seen a number of states introduce legislation that allows state medical boards to go after doctors for medical “misinformation,” which can of course be construed as anything that goes against current orthodoxies. California has approved one of these bills.
We cannot let the FDA gain more power over how medicine is practiced in this country.
Action Alert! Write to Congress and tell them to repeal this new policy that allows the FDA to regulate the practice of medicine. Please send your message immediately.
Neither of those drugs were any use at all for C-19, so you are using a failed strategy for an example. They might have possibly worked for a few people, but without a long winded, comparison study it’s not possible to know whether those same people would have got better without any drug at all – as some do , no matter which disease you are talking about.
You incompetents at the FDA have no authority to interfere with the patient doctor relationship. Look at the terrible job you’ve done with COVID and the “vaccine” amongst other fiascos. The FDA should be disbanded and replaced with an organization that cares about us citizens instead of the drug companies!!!
To the members of Congress:
The FDA is starting to regulate the practice of medicine. Buried in the 4,155 page spending bill Congress recently approved is the innocuous-sounding “Bans of Devices for One or More Intended Uses.” This dangerous provision allows the FDA to ban off-label uses of medical devices while leaving them approved for other uses. This provision expands the FDA’s power to dictate what my doctor can and can’t do. Today, it’s medical devices, but the FDA could easily use this as a precedent to further expand its power to regulate the practice of medicine and enforce a one-size-fits-all vision of medicine.
This bill takes away the doctor-patient relationship, and we have a right to choose what we feel is right for our health. I urge you to please take this egregious authority back from the FDA and leave it to doctors and patients to decide for themselves.
Doctors should be able to practice medicine to benefit the individual patient, and not have to follow dictates by the FDA or any other organization.
The FDA aids having difficulty keeping its focus on its mission: to see that labels are correct. Anything past this chore is over their pay grade. They have absolutely no role in governing how doctors practice medicine.
I am asking Congress to repeal the new policy that allows FDA to regulate the practice of medicine. It is unacceptable that FDA interferes with what my doctor can and cannot do.
The Food, Drug and Cosmetic Act prohibits the FDA from interfering or limiting “with the authority of a health care practitioner to prescribe or administer any legally device to a patient for any condition or disease. The FDA is not allowed to interfere in the practice of medicine!
The FDA’s role is to control which medications and devices are commercially available, not to limit or control how they are prescribed by physicians once the medications are on the market.
The courts held that FDA could ban a medical device altogether if it poses an “unreasonable and substantial risk of illness or injury” but banning an off label use of an approved device is regulating the practice of medicine and therefore prohibited. The FDA violated the law and is trying to get Congress to change it.
We cannot let the FDA gain more power over how medicine is practiced in the country, taking away our health freedoms.
FDA: You cannot limit a doctor’s right to practice medicine or prescribe the way he/she sees fit. I see this as a grab for power but also a way to pander to pharmaceutical interests, so more $$ to them and hence to you.
I’m being blocked by Google! FDA is Corrupt and Doctors MUST have the ability to practice Medicine as they deem Necessary! We the people place our Trust and welfare in Our Drs.; Help is need to lock up the Spike Protein,Vitamins needed! Ivermectine,Hydroxychloriquin, Nebulizing All are Necessary! JoAnn Hamilton 5582 HighlandRiver Rd.28645,NC.
The FDA, well known to be a heavily lobbied part of the government, is sneakily extending its power over doctors and their right to give Americans personalized care. This restriction of single use medical devices will eliminate American medical freedom; vital for about 20% of those receiving care; threatening the health of sensitive patients in our country who cannot tolerate a predetermined single use device; tying the hands of licensed physicians in our country from doing what works best for their patients. The FDA’s failed attempt to make this “one size fits all” approach to medical care restriction a law in the courts should have indicated to Congress it was a bad idea. The fact that Congress has given approval to this FDA spawned, unethical, dangerous Bill “Bans of Devices for One or More Intended Uses” is scandalous! Burying the “Bans of Devices for One or More Intended Uses” Bill within the 4,155 page spending bill demonstrates our elected official’s have been duped by lobbyists or are consciously deceiving the American people and the medical professionals who serve them. This is scandalous; eliminating valuable health devices from our doctor’s legal use.
This bill is an FDA over-reach. The FDA’s role is to control which medications and devices are commercially available, NOT to limit or control how they are prescribed by physicians once the devices, including medicines have been determined safe for use and are on the market. This Wall Street Journal commentary encapsulates how important this is:
“Off-label use in medicine enables physicians to assess their patients’ unique circumstances and use their own evolving scientific knowledge in deciding to try approved products for new indications. If the treatment proves useful, formal studies are performed and published. If enough evidence accumulates, the treatment becomes the standard of care, even if the manufacturer didn’t submit the product for a separate, lengthy and costly FDA review.”
Another example of how this bill brings potential public health loss is the use of intravenously administered vitamin C. Originally prescribed for scurvy, vitamin C is widely used and very effective , helping a wide variety of conditions. This bill is potentially another weapon for “Big Pharma” to use against citizens who want the most effective health care for themselves and a way for big government to eliminate American health care freedoms. This bill must be stopped!
Is it not possible to get that piece of the legislation overturned?
Could you contact a number of members of congress to ask whether they actually realised that was hidden in that legislation and if so – do they realise the implications of it?
It should be illegal to “bury” unrelated pieces of legislation in other legislation – especially something like this inside such a lengthy document that is otherwise – or should just be about budgetary allocations! Could you get a bill passed that blocks that sort of deceitful sleight of hand of slipping in unrelated pieces of legislation??
We live in a country with a constitution that gives the common freedom of life, liberty and pursuit of happiness.
Liberty DOES NOT include regulating the practice of medicine. Furthermore, there are so many options it is unfair to regulate it and unfair to the general public to limit treatment!
Please repeal this new policy that allows the FDA to regulate the practice of medicine.
Repeal this new policy that allows the FDA to regulate the practice of medicine.
The FDA’s role is to control which medications and devices are commercially available, not to limit or control how they are prescribed by physicians once the medications are on the market.
And now why would I need your interference with me and my own personal medical health?
If I need an electrician, don’t you think I’m smart enough to hire someone who has trained AT SCHOOL and got a degree that says they are qualified to be an electrician?
Well, the same qualifies in the school of my medical health.
Please stay out of an area where you have no business sticking your nose into. While you may feel you are protecting us Americans, I feel you are butting into an area you have absolutely no training for butting into.
My healthcare decisions are mine and do not belong to an unelected government bureaucracy that takes money from Big Pharma to promote their deadly drugs. You refuse to listen to independent scientists or have any transparency. My taxes go towards your paychecks and perhaps it’s time to disband the FDA.
The pharmaceutical companies need to stay out of decisions made by doctors! They have no right to limit treatments that work. I am tired of pharmaceutical companies that only want to make more money at peoples expense.