STORY AT-A-GLANCE
- The 2023 omnibus appropriations bill includes 19 lines that could give the U.S. Food and Drug Administration the power to ban off-label use of approved medications
- If the little-noticed provision is passed, doctors’ ability to freely treat patients, and patients’ ability to use all available treatments after making an informed decision, will be lost
- The amendment puts the FDA, and by proxy Big Pharma, at the helm of powerful health care decisions that should be made on an individual, personalized level between a patient and their health care provider
- In California, law AB 2098, which went into effect January 1, 2023, gives the state power to take away doctors’ medical licenses if they spread “misinformation” that goes against the standard COVID-19 rhetoric
- The trend to allow a Pharma-controlled government to silence your doctor and dictate basic components of your medical care is not confined to the U.S. — it’s happening globally
In the U.S., 1 in 5 prescriptions is written for an off-label use.1 While sometimes this allows medications to be overused or misused, it also protects doctors’ ability to freely treat patients, and patients’ ability to use all available treatments after making an informed decision.
That 20% of medications are used off-label also indicates “a degree of freedom physicians currently have that will be foreclosed,” notes English comedian and actor Russell Brand,2 if a little-noticed provision in the omnibus spending bill is passed. “Literally, this will mean that your doctor will not be able to do what’s best for you because they’ll work for Big Pharma now,” Brand says.3
19 Lines in 4,155-Page Bill Could Change Practice of Medicine
The 2023 omnibus appropriations bill — a 4,155-page tome involving $1.7 trillion in spending — includes 19 lines that could give the U.S. Food and Drug Administration the power to ban off-label use of approved medications. In a commentary for The Wall Street Journal, Dr. Joel Zinberg wrote:4
“Physicians routinely prescribe drugs and employ medical devices that are approved and labeled by the Food and Drug Administration for a particular use. Yet sometimes physicians discern other beneficial uses for these technologies, which they prescribe for their patients without specific official sanction.
The new legislation amends the Food, Drug and Cosmetic Act, or FDCA, to give the FDA the authority to ban some of these off-label uses of otherwise approved products. This unwarranted intrusion into the physician-patient relationship threatens to undermine medical innovation and patient care.”
FDA Wants Power to Regulate Practice of Medicine
“The new provision was enacted at the FDA’s urging,” Zinberg says,5 in response to a 2021 legal ruling that limited the FDA’s power to meddle with the practice of medicine. In March 2020, the FDA banned the use of electric shock devices for particular uses, namely to treat patients engaging in self-harm or aggressive behaviors that could harm others.
The devices are FDA approved, and while the FDA banned their use for certain contexts, it still allowed them to be used for smoking addiction and other purposes.6 This led to a lawsuit — Judge Rotenberg Education Center v. FDA — in which the Judge Rotenberg Education Center, a school for people with severe behavioral and intellectual conditions, sued the FDA over the ban.
The court ruled in the school’s favor, stating that the FDA’s ban violated federal law because it interfered with health care practitioners’ authority to practice medicine. As it stands, the FDA does not have the power to ban medical devices for a particular use.
The school’s attorney, Mike Flammia, who also represented students’ parents in favor of the device’s use, told CNN the decision “protects what all of us cherish, and that is the ability to go to our doctor and have our doctor decide what is the best treatment.”7
As it stands, Section 360f of the FDCA8 only gives the FDA authority to ban a medical device if it poses “an unreasonable and substantial risk of illness or injury.” It can ban the device outright, but it can’t pick and choose when it can and can’t be used.
“Barring a practitioner from prescribing or using an otherwise approved device for a specific off-label indication would violate another FDCA section, which bars the FDA from regulating the ‘practice of medicine,'” Zinberg says.9 The FDA is trying to change that.
Pharma — Not Your Doctor — Would Dictate Medical Decisions
The omnibus amendment would change Section 360f so that the FDA could ban a medical device if it poses an unreasonable risk for “one or more intended uses” while leaving it approved for others. “Since the new provision lets the FDA skirt the ban on interfering with the practice of medicine by banning devices for particular uses, the agency will likely claim this as a precedent allowing it to ban off-label uses of drugs as well,” according to Zinberg.10
This puts the FDA, and by proxy Big Pharma…