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 β€” especially those with life-threatening conditions β€” cannot wait for the agency to act. Even with recent changes in the FDCA, if a new use concerns a rare disease β€” or the drug is off-patent β€” 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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What's Political Correctness?

What's Political Correctness?
What’s Political Correctness?

There’s a lot of specific ways to phrase this truth, but the one above is as good as any of them. Political Correctness is giving up you own opinion to please assholes or, at least, censoring what you say or do in order to propitiate them.

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Mr. Musk's New Platform

Mr. Musk's New Platform
Twitter's His Now, Bitches
Mr. Musk’s New Platform

Yesterday, April 25, 2022, Multi-billionaire and the richest single individual in the world, Elon Musk outright purchased Twitter for roughly $44 billion. When your net worth is $264.6Β billion USD, you get to do that, and the Democrats’ government can’t do much about it and is unlikely to even try. πŸ˜‰

Twitter As We Know It Is Over… Maybe

So, if Elon Musk does all, most, or even a significant fraction of what he claims his plans are for renewing and rebirthing Twitter – and, since he’s taking it private, there’s nothing stopping him from doing so – the Twitter that we either love or loath is likely over.

Free speech is the bedrock of a functioning democracy, and Twitter is the digital town square where matters vital to the future of humanity are debated. I also want to make Twitter better than ever by enhancing the product with new features, making the algorithms open source to increase trust, defeating the spam bots, and authenticating all humans. Twitter has tremendous potential – I look forward to working with the company and the community of users to unlock it.

Elon Musk

Read Musk’s statement very carefully. Three words in the 1st sentence of it are very, very important, and firmly grounded in US case law. Those words are, “digital town square.”

As I’ve written before, the SCOTUS has already ruled twice that social media platforms are the modern age’s public or town square and are, as such, bound by the restrictions of the 1st Amendment.

Social media allows users to gain access to information and communicate with one another on any subject that might come to mind. With one broad stroke, North Carolina bars access to what for many are the principal sources for knowing current events, checking ads for employment, speaking and listening in the modern public square, and otherwise exploring the vast realms of human thought and knowledge. Foreclosing access to social media altogether thus prevents users from engaging in the legitimate exercise of First Amendment rights.

β€” Justice Anthony Kennedy
Packingham v. North Carolina, 582 U.S.

So, Twitter is now poised to be transformed into an actual platform for the free exercise of speech… if Mr. Musk actually follows through on his pledge. And truly, the only real thing that could prevent him from doing that is if the market will not bear it and Twitter’s federally limited number of stockholders find this too painful to tolerate. That seems more than little unlikely given people’s addiction to social media in general and Twitter in specific.

Now, it’s true that word of Musk’s now essentially fulfilled intent to buy Twitter spurred certain sorts of users, including some high-profile ones, to “say” #GoodByeTwitter, we’ve all seen, heard, and/or read about that sort of promised exodus before. πŸ˜‰ So I doubt there will be much in the way of financial fallout from the buyout and proposed changes.

So, the ball is in Elon Musk’s court. Elon Musk’s new platform will largely be whatever he wants it to be. He owns it after all. I’ve some hope for it, but that hope is seasoned by long experience.

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Enforcing Gleichschaltung

Dems Enforcing Gleichschaltung
Dems And Their SA Enforcing Gleichschaltung

As Americans have witnessed and all to often been subject to in recent years, the Democrats and their media outlets are more than both willing and capable of enforcing Gleichschaltung. And, as every sane person fully expected, it’s growing worse and more overt since the Dems overthrew the American government and installed the Biden-Harris regime.

And, it’s not something that could happen here; it is something that is happening here! For far too long, in willful blindness to the Democrats’ ever-increasing encroachment upon the fundamental rights and mores of our nation, good citizens have looked on and did nothing as the Democrats and those sorts who support them have chipped away at the foundations of America.

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There Is Only One Way

There Is Only One Way

Exactly! You can’t have it both ways because there is only one way under Natural/Divine Law, which is specifically enumerated by the US Constitution. You have your inalienable rights and those business owners have them too.

And no! I’m very much not one of those who’ve jumped on the Pandemic Panic bandwagon. Frankly, a disease with a 0.28% Crude Mortality Rate (CMR) and a 1.4% Infection Mortality Rate (IMR) doesn’t particularly impress me, especially when only 4.5% of those deaths occurred in people under the age of 65 who did not have an underlying medical condition such as: Diabetes, Lung Disease, Cancer, Immunodeficiency, Heart Disease, Hypertension, Asthma, Kidney Disease, GI/Liver Disease, and Obesity. But this isn’t about COVID-19; it’s about rights and what’s right and what’s wrong.

It was and is the same thing as businesses saying that you can’t bring your firearm into them. It’s their right. It’s also the same thing as businesses setting a basic dress-code. It’s their right.

You have a right to your person, but they have a right to their persons and their property. So, don’t be an asshole. You’re far closer to being an oppressor by doing so than those business owners are by exercising their rights.

You also have the right to just not patronize those businesses, just as they have the right to tell you that they don’t want your business.

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