Posted on 02/23/2023 8:24:13 AM PST by Twotone
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.
The authority to ban off-label uses was buried on page 3,542 of the 4,155-page omnibus appropriations bill signed into law at year's end, though it's specifically applied to "banned devices."
The FDA requested this "very unprecedented" update after a string of court losses, Endpoints News senior editor Zachary Brennan told WBUR earlier this month, while cautioning that it's not clear whether the agency could broadly interpret "devices" to cover drug treatments.
Law firm Morrison Foerster specifically credited the revision to a 2021 ruling by the U.S. Court of Appeals for the D.C. Circuit that prohibited the FDA from banning "individual intended usages of an otherwise legally marketed device," in that case "electrical stimulation devices used to treat aggressive or self-injurious behavior."
Some physicians aren't trusting the FDA to restrain itself. "FDA lobbyists got congress [sic] to grant the agency (not practicing doctors) the power to ban some uses of medications," Johns Hopkins medical professor and National Academy of Medicine member Marty Makary tweeted Tuesday.
"That's truly arrogant to think that the federal government is the one and only one who knows better than the physicians at the state boards of medicine about what good medicine is or what it isn't," medical device and drug regulatory lawyer Brad Thompson told WBUR.
(Excerpt) Read more at justthenews.com ...
Big Pharma at work.......................again...................
Is ivermectin something that could be sold over the counter? If so problem solved.
Just a bit more government over reach.
So Pfizer et al can use the FDA to keep the profits rolling in...
Bureaucrats just can’t resist the urge to control others.
EVERYTHING is corrupt!!!!.
Its just unbelievable anymore!!!!!!
For years FDA has wanted the power to “drug-i-fy” vitamins. This effort extended to even the simplest and most widely used vitamins like C and D.
It would also act against the availability of more subtle and secondary things like Ginko and Mellotonin.
FDA wants to force expensive and lengthy “safe & effective” clinical trials. Many vitamins would disappear or be prohibitively expensive to no great improvement in safety.
They just want Control...
“Is ivermectin something that could be sold over the counter?”
You can get the equine version from Amazon.
Government corporatism — 10% for the Big Guy.
If it’s right for a minor to take an abortion pill to kill her baby, but it’s wrong for an adult to take ivermectin to treat covid...you might be a Democrat.
Post of the day award!!!
If Pfizer had a patent on Ivermectin, the Govt would be handing it out like candy.
PROVEN murderers are given MORE power,
.... instead of accountability and prison.
This is a clear example of why there will never be a real cancer cure - too much existing profit at stake.
what ever happened to Right to Try?
And soon they’ll have gotten rid of the entire egg inductry since it was discovered that yolks block the covid activity..
I think there’s a couple of states where it’s sold OTC.
“This is a clear example of why there will never be a real cancer cure - too much existing profit at stake.”
Adenoid Cystic Carcinoma, one of the least common types of cancer globally, currently lacks an FDA-approved medication for its treatment.
However, there are drugs available that show potential in treating ACC. The “Right to Try” policy, implemented during Trump’s presidency, allows patients to use off-label drugs if a doctor believes they could be effective, offering an alternative to giving up hope. With the right to try some insurance companies would pay for those drugs. Some patients have beaten ACC or extended their lives with off-label drugs.
I guess this another policy being undone by the Biden administration. Only the rich will be able to afford treatment now.
Ivermectin doesn’t do anything for covid. But trying to outlaw people wanting to buy it is just authoritarian. People take all kinds of crap they think is healthy which doesn’t do a damned thing. Let people waste their money if they want to.
Here’s a review of all the studies on ivermectin with covid.
https://astralcodexten.substack.com/p/response-to-alexandros-contra-me
"Not just ivermectin: New FDA authority [??? emphasis added] to ban off-label uses alarms doctors"
FR: Never Accept the Premise of Your Opponent’s Argument
Patriots need to diplomatically inform their institutionally indoctrinated, constitutionally low-information medical doctors that the states have never expressly constitutionally given the big, bad, post-17th Amendment (17A) ratification feds the specific power to dictate peacetime INTRAstate healthcare policy.
"10th Amendment: The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people."
"From the accepted doctrine that the United States is a government of delegated powers, it follows that those not expressly granted, or reasonably to be implied from such as are conferred, are reserved to the states, or to the people. To forestall any suggestion to the contrary, the Tenth Amendment was adopted. The same proposition, otherwise stated, is that powers not granted are prohibited [emphasis added]." —United States v. Butler, 1936.
And even if the states had expressly constitutionally given the feds such power, it remains that the states have constitutionally authorized only popularly elected federal government leaders to make such decisions.
"Article I, Section 1; All legislative Powers herein granted shall be vested in a Congress of the United States, which shall consist of a Senate and House of Representatives [and the FDA, EPA, IRS, etc.?]."
The drafters of the Constitution had expected federal lawmakers to risk losing their offices for supporting unpopular legislation.
But post-17A lawmakers discovered that they afford themselves some unconstitutional job security by establishing constitutionally undefined, so-called "federal regulatory agencies" run by non-popularly-elected state and federal government bureaucrats who did legislators' dirty work for them.
After all, no big deal if unconstitutional state and federal bureaucracies wrongly weaken the constitutionally enumerated voting power of ordinary qualified citizens voters. /sarc
Government bureaucrats undoubtedly helped to foster the emergence of infamous career lawmakers.
Regarding unconstitutional FDA edicts, the following excerpts are from the writings of constitutional experts who had clarified that the federal government has no express constitutional authority to dictate intrastate healthcare policy, not even to try to stop the spread of disease.
"10th Amendment: The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people."
"Many are the exercises of power reserved to the States wherein a uniformity of proceeding would be advantageous to all. Such are quarantines, health laws [emphasis added], regulations of the press, banking institutions, training militia, etc., etc." —Thomas Jefferson to James Sullivan, 1807.
"Congress is not empowered to tax for those purposes which are within the exclusive province of the States." —Justice John Marshall, Gibbons v. Ogden, 1824.
"They form a portion of that immense mass of legislation, which embrace every thing in the territory of a state not surrendered to the general government. Inspection laws, quarantine laws, and health laws [emphasis added], as well as laws for regulating the internal commerce of a state, and others, which respect roads, fences, &c. are component parts of state legislation, resulting from the residuary powers of state sovereignty. No direct power over these is given to congress, and consequently they remain subject to state legislation, though they may be controlled by congress, when they interfere with their acknowledged powers." —Justice Joseph Story, Article I, Section 10, Clause 2, 1833.
“Inspection laws, quarantine laws, health laws of every description [emphasis added], as well as laws for regulating the internal commerce of a state and those which respect turnpike roads, ferries, &c., are component parts of this mass.” —Justice Barbour, New York v. Miln., 1837.
"From the accepted doctrine that the United States is a government of delegated powers, it follows that those not expressly granted, or reasonably to be implied from such as are conferred, are reserved to the states, or to the people. To forestall any suggestion to the contrary, the Tenth Amendment was adopted. The same proposition, otherwise stated, is that powers not granted are prohibited [emphasis added]." —United States v. Butler, 1936.
Below are excerpts from Supreme Court case opinions and congressional record that don't mention quarantine, but support the constitutional reality that healthcare issues, politically correct (imo) mandating of masks argued to slow spread of contagious diseases for example, is a state power issue, not the business of the feds.
”State inspection laws, health laws, and laws for regulating the internal commerce of a State, and those which respect turnpike roads, ferries, &c. are not within the power granted to Congress [emphases added]” —Gibbons v. Ogden, 1824.
From the congressional record, clarification by Rep. John Bingham, the main author of Section 1 of the 14th Amendment:
”Simply this, that the care of the property, the liberty, and the life of the citizen, under the solemn sanction of an oath imposed by your Constitution, is in the States and not in the federal government [emphases added]. I have sought to effect no change in that respect in the Constitution of the country.” —John Bingham, Congressional. Globe. 1866, page 1292 (see top half of third column)
“Direct control of medical practice in the states is obviously beyond the power of Congress [emphases added].” –Linder v. United States, 1925.
Patriots, the bottom line is this imo. What is your threshold of “pain” for peacefully stopping unconstitutionally big state and federal governments controlled by bully, constitutionally undefined political parties, from oppressing the people under their boots?
The inevitable remedy for ongoing, post-17A ratification, corrupt political party treason (imo)...
All MAGA patriots need to wake up their RINO federal and state lawmakers by making the following clear to them.
If they don’t publicly support either a resolution, or a Constitutional Convention, to effectively "secede" ALL the states from the unconstitutionally big federal government by amending the Constitution to repeal the 16th (direct taxes) and 17th (popular voting for federal senators) Amendments (16&17A), doing so before the primary elections in 2024, that YOU will primary them.
If the proposed amendment was limited strictly to repealing 16&17A, relatively little or ideally no discussion would be needed before ratification of the amendment imo.
With 16&17A out of the way, my hope is that Trump 47 becomes the FIRST president of a truly constitutionally limited power federal government.
In the meanwhile, I'm not holding my breath for significant MAGA legislation to appear in the first 100 days of new term for what may still prove to be another RINO-controlled House.
Trump will hopefully do another round of primarying RINOs for 2024 elections.
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