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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Seemingly Every Time

Seemingly Every Time
Seemingly Every Time…

That’s the sad truth these days. Seemingly every time an election’s ballot count is delayed, a Democrat is declared the victor. It’s like they need to do a preliminary check in order to determine how close the votes are, and then, if needed, demand the time to wrangle up the Emergency Democrat Votes.

Now, correlation is not causation. But when there’s repeated enough correlation to produce a pattern, there’s evidence enough not to ever trust the results or grant respect or authority-in-practice to the Democrats “elected” in these political races. Usurpers are not democratically elected and, once proven by preponderance of evidence to be so, the People need not limit themselves to democratic means to remove them.

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So, Musk Is Saving Twitter

Musk Is Saving Twitter
Musk Is Saving Twitter

We now, as of Friday, November 19, 2022, have empirical evidence that Elon Musk is saving Twitter and greatly reducing the use of the social media platform for spread misinformation/disinformation to the world’s public. Apparently CBS has “suspended” its Twitter use. The Democrat propaganda outlet has indefinitely put a hold posting new tweets in the wake of Elon Musk’s purchase of Twitter and his subsequent cessation of censoring voices that run contrary to the Lamestream Media’s comfort.

It is thought that other media outlets which purport to be journalism will do the same in the coming days, weeks, or months. And that, Ladies and Gentlemen, would go a long way towards saving Twitter from continuing to be the Orwellian, Social Justice Safe Space the ex or soon to be ex staff turned it into over the years.

So, much to the chagrin of Liberals, Progressives, and other crybullies, Musk is saving Twitter.

Vox Populi, Vox Dei!

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But Israel Is Racist

But Israel Is Racist When They Do It
But Israel Is Racist

Ah, the consistent illogic and bias of Anti-Semites worldwide, and especially those polluting our nation with their living within its borders. The Muslims of both the West Bank and the Palestinian Authority have long ago codified that the official religion of their areas is Islam and their official language is Arabic, and this is somewhere between A-OK and ignored by the Left, who hate Israel and any Jews who are insufficiently Leftist and critical of Israel’s existence. And, at the same time, Israel being formally a Jewish nation and having Hebrew as its national language is by their accounting racist – an example in their hate-filled minds of how Israel is an apartheid state.

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No Forgiveness For Biden

No Forgiveness For Biden
No Forgiveness For Biden

There’s no forgiveness for Biden. Specifically, there’s no ill-conceived and illegal student loan forgiveness for him and whichever group of his handlers had him sign the Executive Order to cancel approximately $400 billion in voluntarily incurred student loan debt. His or their plan to buy a plethora of 2024 votes with federal monies is essentially dead in the water at this point.

First a federal judge in Texas blocked it. Then, just a days later and regarding a separate suit against Biden, a unanimous ruling by the 8th Circuit Court of Appeals in St. Louis blocked it again via injunction. Most likely, if the Texas ruling goes for appeal, the 5th US Circuit Court of Appeals will do as the 8th did. Even if they don’t, however, the 8th Circuit Court of Appeals’ injunction against it will still stand until that Court reaches a final decision in State of Nebraska v. Joseph Biden, Jr..

😉 It’s dead, Joe. Shuffle away and forget about it.

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