After a string of court losses concerning the ability for doctors to prescribe drugs for off-label uses for which they were not approved, Congress has quietly given the Food and Drug Administration (FDA) more power to prohibit off-label use .
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This is an alarming situation. The growing influence of corporations in our daily lives is paving the way for robots to take over certain medical tasks and replacing the human interaction and shared decision-making between doctors and patients.
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Very alarming. May be time to stock up on Rapamycin.
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80% of my prescribing is off label
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I don’t see how pharma companies would allow this
SO much prescribing is off label. It would be huge hit to revenue and it would be expensive to get every drug approved for every indication it’s currently used for.
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The amendment refers to
SEC. 3306. BANS OF DEVICES FOR ONE OR MORE INTENDED
page 3542.
That does not include drugs, because the term device is defined as:
(1) The term “device” (except when used in paragraph (n) of this section and in sections 331(i) , 343(f) , 352(c) , and 362(c) of this title ) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is— (A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 360j( o ) of this title.
So if has to enter the body to achieve its effect, and needs to be metabolized, then it is not a device. So the amendment clearly excludes drugs.
Alarmist.
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This is why people are trying to brew their own drugs in the basement.
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Might not be so alarmist, or clear for that matter, because the wording of it is sketchy.
The key word here is “or.”
The general wording of the items listed is like this: “The term device… means… (A)… (B)… or (C).”
The use of the word “or” indicates that it is not a combination of these three items, but any of these three items that qualify; so, (A) OR (B) OR (C), not (A) AND (B) AND (C).
For instance, it can be read as any device that:
-
(A) Is in the National Formulary or United States Pharmacopeia
OR -
(B) If it isn’t in the National Formulary or United States Pharmacopeia,
THEN drugs/medicine for use in treating humans or other animals
OR - (C) If it’s not in the National Formulary or United States Pharmacopeia,
NOR is a drug/medicine for use in treating humans or other animals,
THEN any device that isn’t necessarily metabolized, but still used to treat humans or other animals
I suspect this wording is a way to “cover all bases.”
For instance, there are medical devices, such as electrotherapy devices, which are commonly used for off-label therapies. I know many athletes use electrotherapy to assist in injury healing or to stimulate particular muscle groups for pain relief or other purposes.
This doesn’t achieve its effect metabolically, so it wouldn’t be covered in item (A) or (B), so this is likely why they threw in item (C) as a way to regulate cases such as this, too.
This is a common thing in medical legalese, so it is wholly dependent on how literal the judges are in interpreting the wording of this article. If they choose to interpret it literally, then it is any of the items (A), (B), or (C). Very, very risky and concerning stuff. As if our healthcare system wasn’t fucked enough…
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It’s not the pharma companies pushing this. It’s the FDA. Good 'ol, can’t-be-wrong, totally-sensible F(ucking)D(umb)A(sses).
It doesn’t have to make sense to be pushed by the FDA. They just love putting regulatory red tape whenever, wherever they can, even when it’s complete nonsense. And while they’re busy forcing that crap through Congress, they’ll then turn a blind eye towards the rampant fraud in the “natural and organic” industry, which is neither natural nor organic (but as long as your chickens get out of their cages for 6 hours before locking them up for another 18 hours, it’s A-OK to say they’re cage-free!).
I really wish they put their regulatory powers towards stuff that actually matters for the majority, rather than constantly concerning themselves with the few who do things that only affect themselves.
Your post is about devices.
The title of the article referred to, is
Doctors Bristle At New FDA Authority To Ban Off-Label Uses For Drugs
That is why I showed that the amendment covers devices, not drugs. It is in that sense that the title of the article is alarmist. The amendment cannot cover drugs, because of the way devices are defined.
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Ah, I should have clarified this.
In legal terminology, “device” does not necessarily mean a mechanical device such as your mobile phone. It is a broad term that means anything that can be used to achieve a purpose.
That is why it sets a very concerning precedent, because the definitions of these things are subject to change depending on the interpretation made by the judges.
The best example of this recently, of course, is the overturning of Roe v. Wade. One set of judges interpreted the definitions one way, but the precedents set by a few fringe cases in recent years let the current justices overturn it for another definition.
“Device” is just not far away enough from “drug” for us to just ignore this. This isn’t even mentioning all the other precedents that the FDA has been setting regarding their interference with doctors doing off-label use. For example, remember ivermectin being effectively banned by the FDA? Regardless of whether or not ivermectin was a legitimate treatment for COVID, the FDA stepped in to attempt to regulate its off-label use, and it isn’t the first time.
The FDA has had a long string of instances such as this, but so far it has all been informal - they exercised their soft power to control off-label use. Now that legislation is popping up that codifies their power in the law, it’s quite concerning.
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Genus Medical Technologies LLC v. United States Food and Drug Administration, No. 20-5026 (D.C. Cir. 2021)
Second page
Because the two definitions share a common “intended-use clause”—that is, both definitions include articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease—and because the drug definition features no other relevant limitations, it is apparent that any product that satisfies the “device” definition also satisfies the definition of a “drug.” The converse, however, is not true. Because a device must be “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article,” and further, because it may neither “achieve its primary intended purposes through chemical action within or on the body of man” nor be “dependent upon being metabolized for the achievement of its primary intended purposes,”2 the set of products that satisfy the device definition is necessarily encompassed by, but narrowerthan, the set of products that satisfy the drug definition.
Drugs and devices are subject to distinct regulatory regimes.
Last page
Instead, we necessarily address only the FDA’s conclusion that the FDCA grants it discretion to classify as a “drug” any product that meets the statutory definition of a “device.” We hold that it does not. Excepting combination products, see 21 U.S.C. § 353(g), devices must be regulated as devices and drugs—if they do not also satisfy the device definition—must be regulated as drugs .8 Thus, the FDA’s decision must be set aside because it was based on an erroneous interpretation of law. See 5 U.S.C. § 706(2)
Rapamycin, acarbose, and all the other allopathics discussed here are solely drugs, not combination drug/device. They do not come under the rubric of an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article. So the FDA has to regulate them as such - drugs. So the amendment does not reach pure drugs like what we discuss here.
This is exactly what I was talking about. That case is one out of many that could have decided “device” means “drug” and vice versa. And that was just from 2021!
There are many more active cases that are still testing these definitions, so the fact that “device” has been tacitly decided by the FDA to exclude off-label use means that the precedent is now dangerously close to “drugs” being included as well.
This issue is in flux, and I understand that you’re pointing out that, as of now, it’s technically still safe for off-label drug use. But two years ago, it wasn’t. Two years from now, that might flip again.
They’ve been going back and forth for a while now, and I just don’t have faith that the FDA will give up on this crusade. We’ve been lucky so far that plaintiffs have been able to win some cases, but them winning this “device” case means that “drug” isn’t off the table yet.
Using the term “alarmist”, ignores all the reprehensible things the FDA, CDC, and government have done the past few years.
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The adjective is used only to described the title of the article, in relation to its subject matter.
From the linked WBUR On Point article:
“It’s strictly related to device regulation. And strictly related to the banning of devices. So, you know, I guess you can always kind of make the claim that there’s a slippery slope to, you know, therapeutics and drugs and how the FDA regulates off label use and all of that. But, you know, just based on the language of what’s in the omnibus, it just related to devices. So anything else is kind of a hypothetical. We’ll see what happens in the future.”
- Zachary Brennan, senior editor at Endpoints News, where he covers the U.S. regulatory agency. (@ZacharyBrennan)