6 ms·

“The GED is a treatment of last resort ... ” Sure it is. And if it is referred to in plain language as a treatment it sure sounds like it falls under the purv

“The GED is a treatment of last resort ... ” Sure it is. And if it is referred to in plain language as a treatment it sure sounds like it falls under the purview of the FDA to regulate it.

s1artibartfast 5y ago
As someone familiar with this area, it is much more complicated than that. The FDA has legal restrictions on what it can and can't regulate. At the heart of this ruling is the fact that the FDA is forbidden from regulating the practice of medicine. State law is required to regulate the practice of medicine. from the Dissenting opinion: >There is no dispute that the FDA has power under the statute to ban a medical device altogether—i.e., across all its potential uses. The issue in this case is whether the FDA can exercise its banning authority in a more tailored fashion: rather than ban a device across the board, can the agency ban the device for a particular intended use while allowing it for other uses?[1] The question becomes, once a device is approved, does banning it for a specific use constitute regulating the practice of medicine. [1] https://www.govinfo.gov/content/pkg/USCOURTS-caDC-20-01087/pdf/USCOURTS-caDC-20-01087-0.pdf https://www.govinfo.gov/content/pkg/USCOURTS-caDC-20-01087/p...
- jjk166 5y ago
  The FDA regulates medical device safety and effectiveness. Something that is safe and effective if used one way can most certainly be unsafe or ineffective if used in another way. Viagra as a treatment for erectile dysfunction? Safe and effective. Viagra as a treatment for low blood pressure? Extremely unsafe and the opposite of effective. And specifically, the law restricting the FDA from regulating the practice of medicine reads: > Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations. While this clearly leaves open the option for general off-label use, I don't read this as barring the FDA from limiting a specific form of off-label use. The decision also relies on some peculiar interpretations of language - for example it recognizes that the FDA has the right to impose use-specific restrictions on a device, but does not consider a ban to be a subcategory of restriction. And reading the definition of device which is intended to distinguish between a device used for medicine vs one that is not (which obviously ties a device's classification to how it is utilized) as implying use is irrelevant simply because the word disease is not explicitly singular seems absurd. Consider a test that distinguishes bacterial from viral infections - it doesn't make sense to label it as a separate device for every single viral and bacterial disease, but that doesn't mean it's use is irrelevant. And an important point from the dissent: > The devices, for instance, can be used to treat smoking addiction. When used for that purpose, the agency found, the devices present a different, and acceptable, benefit-risk profile. Id. at 13,317. That is in part because a smoker typically controls the device and can stop its use when it causes undue pain, and she can also communicate any harmful symptoms to a healthcare provider. Id. By contrast, persons with intellectual or developmental disabilities receiving treatment for self-injurious or aggressive behaviors often do not control the electrical stimulation devices they wear (rather, the devices are controlled by a third party or automatically trigger upon detecting certain movements). Id.; Proposed Rule, 81 Fed. Reg. at 24,394, 24,396. Those persons also may lack the ability to discern a causal connection between the devices and physical or psychological harm, or may be unable to communicate the harmful symptoms to others. It's not just what they're using the device for, it's how the device is physically designed to be used. Imagine a defibrillator that instead of going off when an operator pushes a button, instead goes off at random intervals. Imagine a medical radiation source with its radiation shield that controls dosage removed. Imagine an anesthetic delivery system that delivered the same amount of anesthetic to every patient regardless of their physiology. Changing how a device is controlled changes the device, and the FDA should most certainly have the power to ban devices with clearly unsafe or ineffective control schemes. I very strongly agree with the dissenting opinion on this one, and I hope this ruling gets overturned.
  - s1artibartfast 5y ago
    First off, I totally agree that the manufacture and approval drugs and devices can be regulated differently with respect to different intended uses. Also, there are specifics that I think both the majority and dissenting opinions got wrong. However, the key is that the FDA has jurisdiction over the manufacture and sale of devices, and no jurisdiction whatsoever over practice of doctors. >While this clearly leaves open the option for general off-label use, I don't read this as barring the FDA from limiting a specific form of off-label use There is no back door for intervening in the practice of medicine for specific forms of off-label use. They can go after manufacturers of products frequently used off label; they can make them add warnings, and perhaps even pull the product from the market, but they can't tell doctors what to do with a product that legally on market. For example, the FDA can't stop doctors from prescribing Viagra off-label as a cure for cancer, even if it is both dangerous and ineffective. The FDA can arrest doctors for prescribing Viagra for erectile disfunction if the pills are illegally imported from Canada because those pills are not legally on the market. Regulation and enforcement against using Viagra as a cancer cure is the jurisdiction of state legislature. >The FDA should most certainly have the power to ban devices with clearly unsafe or ineffective control schemes. They absolutely do have the power to recall these devices from the market. However, they can't tell doctors what to do with the devices or tell them not to substitute other legally marketed devices off-label. This specific case is complex because this naturally creates a conflict when a device has multiple potential uses, and doctors refuse to head FDA warnings about off label use. The FDA naturally wants to keep the devices on the market for the effective use and discourage the ineffective use, but their hands are tied. It must be like a sheriff staring at a fugitive across the boarder. The problem here is that the FDA is trying to cross the boarder between the manufacture devices and the practice of medicine instead of working within their jurisdiction. They could recall all devices approved with indications for treating Self-Injurious or Aggressive Behavior. They can probably go after the Judge Rotenberg Educational Center in their capacity as manufacturer for knowingly manufacturing a device for off-label use.
    - jjk166 5y ago
      > For example, the FDA can't stop doctors from prescribing Viagra off-label as a cure for cancer, even if it is both dangerous and ineffective. The entire point of the FDA is to make sure the drugs and medical devices being given are safe and effective. Why bother evaluating safety and effectiveness at all if that's supposed to be purely a case by case judgement call by a physician? The statements by congress clearly indicate that the intent of the law is for different use cases to be treated as separate devices, legal precedent clearly indicates that so long as the FDA's interpretation of the statute is reasonable that it should be deferred to by the courts, and their interpretation is reasonable. There is circular reasoning in the belief that the FDA can not impose a partial ban, and thus the device is legally on the market, and thus the FDA does not have the authority to impose a partial ban. You can not separate a device from its usage. The moment you start using an object to beat a nail into a piece of wood, it becomes a hammer, but if you use it to turn a screw, it's not a hammer, it's a screwdriver. If an agency has been invested with the power to ban screwdrivers, the fact that your screwdriver could theoretically be used as a hammer is irrelevant when you are using your screw driver to drive screws.

“The GED is a treatment of last resort ... ” Sure it is. And if it is referred to in plain language as a treatment it sure sounds like it falls under the purview of the FDA to regulate it.

s1artibartfast 5y ago

As someone familiar with this area, it is much more complicated than that. The FDA has legal restrictions on what it can and can't regulate. At the heart of this ruling is the fact that the FDA is forbidden from regulating the practice of medicine. State law is required to regulate the practice of medicine. from the Dissenting opinion: >There is no dispute that the FDA has power under the statute to ban a medical device altogether—i.e., across all its potential uses. The issue in this case is whether the FDA can exercise its banning authority in a more tailored fashion: rather than ban a device across the board, can the agency ban the device for a particular intended use while allowing it for other uses?[1] The question becomes, once a device is approved, does banning it for a specific use constitute regulating the practice of medicine. [1] https://www.govinfo.gov/content/pkg/USCOURTS-caDC-20-01087/pdf/USCOURTS-caDC-20-01087-0.pdf https://www.govinfo.gov/content/pkg/USCOURTS-caDC-20-01087/p...

jjk166 5y ago
The FDA regulates medical device safety and effectiveness. Something that is safe and effective if used one way can most certainly be unsafe or ineffective if used in another way. Viagra as a treatment for erectile dysfunction? Safe and effective. Viagra as a treatment for low blood pressure? Extremely unsafe and the opposite of effective. And specifically, the law restricting the FDA from regulating the practice of medicine reads: > Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations. While this clearly leaves open the option for general off-label use, I don't read this as barring the FDA from limiting a specific form of off-label use. The decision also relies on some peculiar interpretations of language - for example it recognizes that the FDA has the right to impose use-specific restrictions on a device, but does not consider a ban to be a subcategory of restriction. And reading the definition of device which is intended to distinguish between a device used for medicine vs one that is not (which obviously ties a device's classification to how it is utilized) as implying use is irrelevant simply because the word disease is not explicitly singular seems absurd. Consider a test that distinguishes bacterial from viral infections - it doesn't make sense to label it as a separate device for every single viral and bacterial disease, but that doesn't mean it's use is irrelevant. And an important point from the dissent: > The devices, for instance, can be used to treat smoking addiction. When used for that purpose, the agency found, the devices present a different, and acceptable, benefit-risk profile. Id. at 13,317. That is in part because a smoker typically controls the device and can stop its use when it causes undue pain, and she can also communicate any harmful symptoms to a healthcare provider. Id. By contrast, persons with intellectual or developmental disabilities receiving treatment for self-injurious or aggressive behaviors often do not control the electrical stimulation devices they wear (rather, the devices are controlled by a third party or automatically trigger upon detecting certain movements). Id.; Proposed Rule, 81 Fed. Reg. at 24,394, 24,396. Those persons also may lack the ability to discern a causal connection between the devices and physical or psychological harm, or may be unable to communicate the harmful symptoms to others. It's not just what they're using the device for, it's how the device is physically designed to be used. Imagine a defibrillator that instead of going off when an operator pushes a button, instead goes off at random intervals. Imagine a medical radiation source with its radiation shield that controls dosage removed. Imagine an anesthetic delivery system that delivered the same amount of anesthetic to every patient regardless of their physiology. Changing how a device is controlled changes the device, and the FDA should most certainly have the power to ban devices with clearly unsafe or ineffective control schemes. I very strongly agree with the dissenting opinion on this one, and I hope this ruling gets overturned.
- s1artibartfast 5y ago
  First off, I totally agree that the manufacture and approval drugs and devices can be regulated differently with respect to different intended uses. Also, there are specifics that I think both the majority and dissenting opinions got wrong. However, the key is that the FDA has jurisdiction over the manufacture and sale of devices, and no jurisdiction whatsoever over practice of doctors. >While this clearly leaves open the option for general off-label use, I don't read this as barring the FDA from limiting a specific form of off-label use There is no back door for intervening in the practice of medicine for specific forms of off-label use. They can go after manufacturers of products frequently used off label; they can make them add warnings, and perhaps even pull the product from the market, but they can't tell doctors what to do with a product that legally on market. For example, the FDA can't stop doctors from prescribing Viagra off-label as a cure for cancer, even if it is both dangerous and ineffective. The FDA can arrest doctors for prescribing Viagra for erectile disfunction if the pills are illegally imported from Canada because those pills are not legally on the market. Regulation and enforcement against using Viagra as a cancer cure is the jurisdiction of state legislature. >The FDA should most certainly have the power to ban devices with clearly unsafe or ineffective control schemes. They absolutely do have the power to recall these devices from the market. However, they can't tell doctors what to do with the devices or tell them not to substitute other legally marketed devices off-label. This specific case is complex because this naturally creates a conflict when a device has multiple potential uses, and doctors refuse to head FDA warnings about off label use. The FDA naturally wants to keep the devices on the market for the effective use and discourage the ineffective use, but their hands are tied. It must be like a sheriff staring at a fugitive across the boarder. The problem here is that the FDA is trying to cross the boarder between the manufacture devices and the practice of medicine instead of working within their jurisdiction. They could recall all devices approved with indications for treating Self-Injurious or Aggressive Behavior. They can probably go after the Judge Rotenberg Educational Center in their capacity as manufacturer for knowingly manufacturing a device for off-label use.
  - jjk166 5y ago
    > For example, the FDA can't stop doctors from prescribing Viagra off-label as a cure for cancer, even if it is both dangerous and ineffective. The entire point of the FDA is to make sure the drugs and medical devices being given are safe and effective. Why bother evaluating safety and effectiveness at all if that's supposed to be purely a case by case judgement call by a physician? The statements by congress clearly indicate that the intent of the law is for different use cases to be treated as separate devices, legal precedent clearly indicates that so long as the FDA's interpretation of the statute is reasonable that it should be deferred to by the courts, and their interpretation is reasonable. There is circular reasoning in the belief that the FDA can not impose a partial ban, and thus the device is legally on the market, and thus the FDA does not have the authority to impose a partial ban. You can not separate a device from its usage. The moment you start using an object to beat a nail into a piece of wood, it becomes a hammer, but if you use it to turn a screw, it's not a hammer, it's a screwdriver. If an agency has been invested with the power to ban screwdrivers, the fact that your screwdriver could theoretically be used as a hammer is irrelevant when you are using your screw driver to drive screws.