Posted on 02/25/2023 3:34:54 PM PST by george76
A little-noticed provision of the omnibus spending bill could give the agency power to ban off-label use of approved therapies..
Secreted within the 2023 omnibus appropriations bill—4,155 pages, spending $1.7 trillion—is a 19-line section that could change the way medicine is practiced.
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.
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the agency will likely claim this as a precedent allowing it to ban off-label uses of drugs .
This is a problem for many reasons. The statute gives the FDA the power, without any public input, to prevent patients’ access to off-label therapies even though their physicians and their patients have found the treatments to be beneficial or even essential.
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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.
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Substituting regulators’ wisdom for the cost-benefit judgment of physicians and their patients will discourage attempts to use approved products in new and beneficial ways and deprive patients of valuable treatments.
(Excerpt) Read more at wsj.com ...
Past-tense, Joel, you DA.
More government overreach-just what we need…/s
“Substituting regulators’ wisdom for the cost-benefit judgment of physicians and their patients...”
If “scare quotes” were ever justified in any writing, it would be the word “wisdom” in that sentence. What a joke to even think there is any “wisdom” with regulators. They’ve all been captured by the entities they regulate.
In other words... We can’t allow Ivermectin
All aimed at Ivermectin and hydroxychloriquine.
Academic medicine is not the same as real-world medicine.
Sounds like a good reason for legal action asserting the FDA is not authorized by the constitution.
No hydroxychoroquine, ivermectin or Oreo cookies allowed to cure COVID. Unreliable, expensive new therapies only!
The FDA is the government and it’s here to help you!
No Big Deal!
Our communist masters know that the pathetically servile and indolent Aamerican people will just continue to roll over and spread their collective cheeks...
Tyranny is viewed as "bliss"...
What a load of crap…. Politicians voting but reading the bill.
Well. Even if this is the law I’d the land I have a legal work around. I believe right try is also the law of the land. If this were to come to fruition I would continue my practice the same way and if queried about “being allowed” I would make sure the chart reflected my awareness of off label use and invoke right to try. At that point there would be a test case in which I would be happy to participate and a deep bench of lawyers who would love to make the argument.
Remember. There are always work arounds. Even with off label use we might disagree with as colleagues, I think the vast majority of us would defend the right to exercise our learned judgments. What will come out of this is there will be some clear requirement to document that patient is aware of off label use.
I am going to guess FDA will realize what a pain in the ass this will turn iout to be for them and that will cause this to be walked back or simply not enforced.
Maybe we need to stop the revolving door of FDA, Pharma folks. https://www.pfizer.com/people/leadership/board-of-directors/scott_gottlieb-md
It happens, too often.
FDA..F, Democratic Assholes
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