FDA’s Lethal Regulations

FDA's Lethal Regulations
FDA’s Lethal Regulations

As with all regulatory agencies when left unchecked, the FDA causes great harm through its hyper-authoritarian stances and rules as well as preventing harm through other rules. It’s why such agencies, operating outside of legislation but having the force of law, need to be regularly checked and forced to defend their actions by properly elected officials.

A perfect case in point is the FDA’s lethal regulations that categorically and absolutely forbid drug manufacturers engaging in any form of speech which can be construed as describing or promoting a use of their drug(s) for any use other than an the FDA approved on-label use, even if the information about this other use is entirely truthful, totally non-misleading, and could help physicians better treat their patients.

As a result of the FDA’s interpretation of the Federal Food, Drug and Cosmetic Act (FDCA), manufacturers of pharmaceuticals may face severe penalties for disseminating truthful and non-misleading information about off-label uses before those uses are approved by the FDA. Indeed, some companies have paid settlements of hundreds of millions or billions of dollars in the face of threatened prosecution or trial in civil false claims cases. Governments and other private actors do not suffer the same burdens on their speech, even though the pharmaceutical manufacturer likely has the most complete, up-to-date, and useful information about the product. Moreover, even when it makes economic sense for a pharmaceutical manufacturer to seek FDA approval for a new use, the FDA can take many months or even years to approve such new uses. Patients — especially those with life-threatening conditions — cannot wait for the agency to act. Even with recent changes in the FDCA, if a new use concerns a rare disease — or the drug is off-patent — it may not be economical for the pharmaceutical manufacturer to seek approval of a new use.

Regulatory Transparency Project

And, sadly, this is lethal regulatory intransigence and tyranny. It has killed, is killing, and will continue to kill people. And all for no valid purposes other than keeping the manufacturers of pharmaceuticals on their proverbial knees before the Deep State and maintaining the perceived relevance – and budget appropriations – of the FDA.

With the FDA censoring what drug makers can publish – even when it’s true, simply presented, and efficacious – many doctors aren’t able to know that there are alternative, off-label, treatment options available for their patients. Similarly, this censorship makes it functionally and legally impossible for health insurance providers to cover the costs of those prescriptions. That has, can, and will kill people – all for the sake of the powermongers of the FDA.

This seems to be no longer be true, but in my day, if you wanted to try CHANTIX to aid you in stopping smoking, insurance wouldn’t cover it because it was an off-label use of the medication.

And, if we’re to even begin to believe the current, #Woke sorts, this is systemic racism since non-Whites, especially the Blacks, are less likely to be able to afford medications that aren’t covered by health insurance. Hence, they’re “disproportionately impacted” by the FDA’s lethal regulations upon free speech involving medicines’ uses.

Honestly, American or Democrat, everyone should be calling for a end to the FDA’s lethal regulation and censorship and calling upon the organization to account for and defend its regulations – which aren’t laws but carry the weight thereof without Legislative oversight – or be forced to abandon them.

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The Evolution Of Medicine

The Evolution Of Medicine
The Evolution Of Medicine

It’s a sad fact that the evolution of medicine, especially in America, has been an evolution from providing medical services to becoming a massively profitable industry focused at least as much on making money as in treating or curing medical conditions. Indeed, it has evolved so far along that path that the medical industry – as opposed to, mind you, the majority of doctors – much prefers to treat diseases’ symptoms, rather than cure them.

Think about it for a moment. The pharmaceutical industry, which comprises only slightly more than 10% of the US medical industry’s wealth-based power, has repeatedly been able to dictate terms to the US government in order to protect themselves from income-damaging legislation.

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Pseudepigraphal Spring

Pseudepigraphal Spring
Pseudepigraphal Spring

And lo! As it was written in Claritin 3:16, No pollen formed against shall prosper! ROFLMAO We are firm in spirit of our Lord and clear in head by his grace. Neither pollen nor dust shall sway us.

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COVID Booster Acceptance

This Just Might Explain The Low COVID Booster Acceptance

This just might explain the low COVID booster acceptance, and a bit of the COVID vaccine acceptance too. 😛

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Is It In The Water?

I’ve been feeling exhaustipated and I’ve been unsure as to why. I’ve considered that it could be some combination of: politics, society’s degeneration, work, life, the weather, or some combination of any number of these factors.

Fukitol
Fukitol – 1000mg Once Daily

Perhaps though, it’s accidental or deliberate pollution of my water supply. It wouldn’t be the first time that drugs were added to our water or the first time that drug residues and pharmacological pollutants found there way into either.

My being exposed to steady, low doses of Fukitol could be to blame for my exhaustipation. It could also explain the low voter turnout in the 2012 elections and why Liberals and Progressives, fond of their bottled designer water, were less affected by it.

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