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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Mind, Body, Soul

Book Yoga - Mind, Body, Soul
Book Yoga – Mind, Body, Soul

Ah, yoga. It’s always been about centering and calming the mind, body, and soul. And, with a few variations, even works in these days. 😆 So, light up that Old Book Smell candle and be well.

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Health Measures

Health Measures
Healthy Measurements
Th
Health Measures That Save Lives

Taking proper health measures, both physical and mental, is more than little important. So, remember that science says that thick thighs save lives, societal studies show that curvier women are happier, and there’s quantifiable and qualitative evidence pointing to this being very good for men’s health as well.

Thick Thighs Save Lives & Make Them Better

So, take health measures – and measurements 😆 – but be moderate in how seriously you take them. After all, don’t let your mental health suffer unduly for the sake of your physical health. That wouldn’t help anyone or make anyone happier, so why do it?

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Not Suitable For Democrats

Home COVID-19 Tests Are Not Suitable For Democrats
Test Is Not Suitable For Democrats

A few days ago I posted about a simple home COVID-19 test to replace the vaporware ones Biden has promised to deliver. Sadly I guess, I have been notified that those particular tests are not suitable for Democrats.

Apparently constant direct exposure has caused Democrats to undergo olfactory sensory adaptation. Tangentially, this also explains why so many of them think their shit doesn’t stink. 👿

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COVID-19 Tests

COVID-19 Tests Are Easy
COVID-19 Tests

Since Biden has rather badly failed to deliver on his promise to provide the nation with “free” COVID-19 test kits – or, at least, I think he promised that; he often doesn’t speak coherently, so I can’t be 100% sure – here’s a simple and truly free alternative. 😉

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