The FDA wants to “interfere” in the practice of medicine. (More than they already have).
Shockingly, I thought they were already doing this when they banned Ivermectin and Hydroxychloroquine over the last 3 years. But apparently they want a legitimate law on the books now that they can go to for these “important” times when God forbid, a healthcare provider wants to do their job but the government does not want to let them.
The omnibus bill amends Section 360f to allow a finding that a device can pose an unreasonable risk for “one or more intended uses” and ban those uses while leaving it approved for other uses. 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. Yet 1 in 5 prescriptions written are for an off-label use. In some fields off-label use is the rule, not the exception. In oncology, the standard treatment for specific types or stages of cancer often includes the off-label use of one or more drugs. And off-label uses are routine in pediatrics, where scientific, ethical and logistical concerns preclude conducting large trials for approval in children.
Allowing the FDA to ban certain off-label uses will impair clinical progress. 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.
Many prescriptions are written for off label use. Propranolol is used for social anxiety prior to speaking in front of crowds. It is not an anti-anxiety medication, it is a beta blocker that reduces the physical symptoms of anxiety such as racing heart and skin flushing. We use it off label for anxiety all the time. Trazodone for sleep? That will go bye bye. It is technically an SSRI to treat depression, but it makes everyone tired so we use it off label in smaller doses for sleep and rarely use it as therapy for depression any longer. This will also be the end of Adderall for “wake me up” medications. That is off label use. You will be required to have a diagnosis of ADHD or narcolepsy to avoid off label prescribing. All of you on the Ozempic/Mounjaro weight loss craze right now? Yeahhhhhhh, that is off label use for weight loss unless you are diagnosed with diabetes. There are thousands of examples of off label use for medications, and it should be at your healthcare providers descretion to choose what is best for your medical ailment, not let the FDA interfere in that relationship. We already saw what they are capable of during covid, this takes it to a dangerous new level.
You just knew that this was coming after their unprecedented and illegal assault on Ivermectin and HCQ. Honestly, l can’t tell you how happy l am to be retired. I would be in a constant state of rage if l was still in practice and had to follow this cookie cutter, boiler plate practice of medicine. The corporate capture of medicine has obliterated critical thinking. Just follow the algorithm. If your stumped refer. If it’s too complex give it to someone else. If its an acute but not life threatening illness, go to the ER or Urgent Care. What a shit show.
This is both a power grab by the government and a get richer longer scheme for the drug companies. Only the drug companies have the money to run the clinical trials required for FDA approval which means the drug companies will control how drugs can be prescribed. It also allows them to continue their patent monopolies even after the original patent expires. If they patent the off label use as a new method of treatment, obtain FDA approval so the prescribing instructions include the off-label use, they can then sue any generic competitor for inducing infringement of the method of treatment by selling the drug which will have to include the instructions for using the product in that manner. The drug companies may lose some sales from off patent uses during the life of the original patent, but they can nonetheless prevent generic infringement for decades. When the interests of the government and drug companies coincide you should expect bad things to happen.