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Posts Tagged ‘FDA Approval’

How Anthony Fauci Controls Science Globally – LewRockwell LewRockwell.com

Posted by M. C. on January 22, 2022

“He shares the patents with them, and then he sells them to the drug companies, splits the patents with them, and he walks those drugs through the FDA approval process, which he completely controls from the bottom up. And then he gets them approved and in many cases he himself profits. People within his agency can collect $150,000 a year from royalties off each of these products.”

https://www.lewrockwell.com/2022/01/joseph-mercola/how-anthony-fauci-controls-science-globally/

By Joseph Mercola

Mercola.com

Robert F. Kennedy Jr. succinctly summarizes how Dr. Anthony Fauci wields his power to control and manipulate science in this riveting episode of The Jimmy Dore Show.1 Fauci has been painted as a hero throughout the pandemic, an image that is not only misleading but wildly inaccurate, as detailed in Kennedy’s best-selling book, “The Real Anthony Fauci.”

“I wrote the book because so many Americans were looking at Tony Fauci as this kind of savior,” Kennedy said. “… [T]he man on the white horse, or in the white lab coat, that would ride us out of this coronavirus crises but I knew from the beginning … that he does not do public health and has not done public health since the 1980s.”2,3

Rather than looking out for public health, Fauci and his agency, the National Institute of Allergy and Infectious Diseases (NIAID), prioritize pharmaceutical promotion. Kennedy refers to Fauci as the “leader of the pack” when it comes to those promoting pharmaceutical products, profiteering from Big Pharma and promoting their own personal power.

Public Health Plummeted During Fauci’s Reign

In 1984, when Fauci was appointed director of NIAID, 11.8% of Americans had chronic disease, but this has risen sharply since.4 Fauci doesn’t talk about this public health failure — at least not publicly — but as Kennedy noted, it was Fauci’s job to figure out why cases of autism, food allergies, ADHD, sleep disorders, juvenile diabetes, rheumatoid arthritis and many other chronic and infectious diseases have skyrocketed.

It was Fauci’s job to conduct research on these diseases to figure out their etiology and environmental causes to protect public health, but instead he turned the NIAID into an incubator for pharmaceuticals. According to Kennedy:5

“When Tony Fauci came in, 6% of American children had chronic disease. By 2006, 54% had it. We went from being the healthiest country in the world with the healthiest children to the sickest. Literally, we do not even qualify as a developed nation. We are 79th in the world, behind Nicaragua and Costa Rica in terms of our health outcomes.

And why did that happen? Well, the one figure who is more responsible for that than anybody else in the world is Tony Fauci. He is the reason we take more pharmaceutical drugs than any other nation in the world. Three times the average among western countries. We pay the highest prices and have the worst outcomes.”

Fauci’s Multibillion-Dollar Budget Gives Him Immense Power

Fauci has a $7.6 billion annual budget, which in total during his entire tenure is more than half a trillion dollars that he’s been in control of. Instead of using that to reveal the environmental issues leading to outbreaks of chronic disease, he uses the money to develop new drugs, Kennedy explains, which he then farms out to universities:6

“He shares the patents with them, and then he sells them to the drug companies, splits the patents with them, and he walks those drugs through the FDA approval process, which he completely controls from the bottom up. And then he gets them approved and in many cases he himself profits. People within his agency can collect $150,000 a year from royalties off each of these products.”

The NIH owns half the patent for Moderna’s COVID-19 injection, which means that it stands to make billions of dollars as a result. Four of Fauci’s top deputies will also collect $150,000 a year for life as a result — from a product they’re responsible for regulating, an obvious massive conflict of interests.

“The mercantile and commercial interests have overwhelmed the regulatory function at that agency and it no longer does public health — it does pharmaceutical promotion,” Kennedy said.7 As an example, between 2009 and 2016 there were 240 new drugs approved by the FDA, all of which came out of Fauci’s “shop,” he added. “He is the incubator for the whole pharmaceutical industry.”8

How Fauci Controls Science Globally

See the rest here

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When There Wasn’t Enough Hand Sanitizer, Distilleries Stepped Up. Now They’re Facing $14,060 FDA Fees. – Reason.com

Posted by M. C. on December 31, 2020

Government fans have something to celebrate tonight!

Is this the same FDA that approves drugs and vaccines?

https://reason.com/2020/12/30/when-there-wasnt-enough-hand-sanitizer-distilleries-stepped-up-now-theyre-facing-14060-fda-fees/

Jacob Grier

For many American craft distillers, 2020 was already one of their worst years ever. The COVID-19-related closure of tasting rooms and cocktail bars, loss of tourism, and inability to offer in-store sampling slashed their sales revenue and cut them off from their customers. Then this week, just as it seemed they’d made it through the worst of a terrible year, the Food and Drug Administration (FDA) had one more surprise in store: The agency delivered notice to distilleries that had produced hand sanitizer in the early days of the pandemic that they now owe an unexpected fee to the government of more than $14,000.

“I was in literal disbelief when I read it yesterday,” says Aaron Bergh, president and distiller at Calwise Spirits in Paso Robles, California. “I had to confirm with my attorney this morning that it’s true.” The surprise fee caught distillers completely off guard, throwing the already suffering industry into confusion.

When the onset of the pandemic led to a massive increase in demand for hand sanitizer this spring, many distilleries stepped up to alleviate the sudden shortage. The main ingredient in sanitizer is ethanol, which they are in the business of making, albeit typically in more fun and tasty formats. More than 800 distilleries pivoted from spirits to sanitizer, offering it for sale or in many cases donating it to their communities free of charge. Their prompt action helped ensure supplies of sanitizer when it was otherwise unobtainable.

(Even then, the FDA needlessly complicated things, imposing additional requirements on top of guidelines published by the World Health Organization for emergency production. The FDA’s mandate that all alcohol used in sanitizer first be denatured—rendering it undrinkable—created a bottleneck that raised costs for distillers and slowed production.)

Producing sanitizer is viewed as a point of pride in the distilling business, a way that they were able to help their communities in a fearful time of crisis. 

Now, however, that good deed is being punished with unanticipated fees by the FDA. “I compare it to surprise medical billing,” says Becky Harris, president of the American Craft Spirits Association (ACSA) and of Catoctin Creek Distilling in Purcellville, Virginia.

At issue is a provision of the CARES Act that reformed regulation of non-prescription drugs. Under the revised law, distilleries that produced sanitizer have been classified as “over-the-counter drug monograph facilities.” The CARES Act also enacted user fees on these facilities to fund the FDA’s regulatory activities. For small distillers, that means ending the year with a surprise bill for $14,060 due on February 11.

“People are incredibly anxious,” Harris says. “We have been dealing with tons of phone calls talking to individual members and state guilds to tell them what we know and what we don’t know.”

Harris and the ACSA have spent the day trying to learn more details about the law and the FDA’s intentions, but the combination of the holidays and the pandemic makes this a difficult time to reach anyone. “We recognize that this bill [the CARES ACT] was not written specifically for the issue of sanitizer,” Harris says. “The problem that we have right now is that [the fee assessment] is going out to a whole lot of small businesses who are struggling in the pandemic.”

Bergh’s CalWise Spirits is a typical example. He says that his distillery produced 5,000 gallons of hand sanitizer, with distribution prioritized to medical workers and others on the frontlines of the pandemic response. “Some of my hand sanitizer was donated,” he said in a statement today. “The rest was sold at a fraction of the market price. My goal was to get as much out as I could, at as low of a price as I could, while being able to bring my furloughed employees back to work. The hand sanitizer business saved me from bankruptcy—but I didn’t make an enormous profit.”

Potentially compounding the impact of the fee is that it is determined by registration as an OTC (over-the-counter) monograph drug production facility in the previous calendar year. That means that distilleries not only have to contend with this year’s fee; if they fail to update their status with the FDA by tomorrow, they may be liable for an additional fee in 2022 as well.

For now, Harris is advising members not to pay the fee right away. “We want to push back on this,” she says. She’s hopeful that if the FDA has some discretion as to the applicability of the fee, that they will exercise it to exclude distilleries, most of which no longer produce sanitizer and have no intention of continuing to do so now that the emergency shortage has passed. Currently, however, the FDA’s website explicitly notes that facilities that produced sanitizer under the agency’s temporary COVID-19 policy are not exempt. Reason‘s inquiry with the FDA has yet to receive a detailed response, but we will update if we receive one.

Paying a surprise $14,000 bill would be a challenge for small businesses in any year, but it’s a particular challenge for craft distilleries in 2020. An industry survey conducted earlier this year by the Distilled Spirits Council of the United States and the American Distilling Institute projected that sales revenue at craft distilleries would decline by more than $700 million this year, amounting to approximately 40 percent of their sales.

For many distillers, the unexpected fee assessment from the FDA thus arrives as one more substantial blow in an already devastating year. “If you were making sanitizer for your community at a limited capacity, this should not be something you have to deal with,” says Harris. “It will be a slap in the face to make it through all of this and then get hit with this bill.” 

Jacob Grier, a freelance writer, bartender, and consultant based in Portland, is the author of The Rediscovery of Tobacco (Kindle Direct) and Cocktails on Tap (Stewart, Tabori and Chang).

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Coronacrisis and Leviathan | Mises Institute

Posted by M. C. on March 14, 2020

First, we can expect that government controls on travel and assembly will tighten.

The second likely long-term effect is ideological. Already we’re seeing the meme that the crisis has been caused (or at least exacerbated) by “neoliberalism”—that thanks to pervasive (?) libertarian ideology public health agencies were “hollowed out” and thus unable to respond in force:

Of course, we know that in the US the CDC initially prevented private labs from testing or developing new tests without FDA approval. More generally, public (and private) health in the US, as in most countries, operates within a tangled web of federal, state, and local regulations, subsidies, restrictions, and other controls.

https://mises.org/power-market/coronacrisis-and-leviathan?utm_source=Mises+Institute+Subscriptions&utm_campaign=2a2bbe83dc-EMAIL_CAMPAIGN_9_21_2018_9_59_COPY_01&utm_medium=email&utm_term=0_8b52b2e1c0-2a2bbe83dc-228343965

Peter G. Klein

In his magisterial Crisis and Leviathan, Robert Higgs shows that the growth of government in the twentieth century can largely be explained by patterns of crisis and response. These crises can be real (World Wars I and II, the Great Depression, stagflation) or imagined (inequality, the various isms). In either case new government programs, agencies, and policies are established, purportedly as temporary responses to the perceived emergency. But, as Higgs shows with rich historical detail, most of the temporary measures become permanent—either explicitly or in a revised form based on the original.

As I summarized Higgs’s thesis in an earlier paper:

Higgs (1987) noted that the expanded role taken on by the state during the New Deal period remained largely in place once the crisis passed, leading to a “ratchet effect” in which government agencies expand to exploit perceived short-term opportunities, but fail to retreat once circumstances change. Higgs (1987) suggests that government officials (regulators, courts, and elected officials), as well as private agents (such as business executives, farmers, and labor unions) developed capabilities in economic and social planning during crisis periods and that, due to indivisibilities and high transaction costs, tend to possess excess capacity in periods between crises. To leverage this capacity, they looked for ways to keep these “temporary” measures in place. Indeed, many New Deal agencies were thinly disguised versions of World War I agencies that had remained dormant throughout the 1920s—the War Industries Board became the National Recovery Administration, the War Finance Corporation became the Reconstruction Finance Corporation, the War Labor Board became the National Labor Relations Board, and so on. In many cases the charters for the New Deal agencies were mostly copied verbatim from World War I predecessors. Higgs’ (1987) ratchet effect illustrates that excess capacity in organizational capabilities isn’t necessary leveraged as soon as it is created, leading to smooth, continuous organizational growth, but may remain dormant until the right economic, legal, or political circumstances arise, leading to sudden, discontinuous jumps in organizational size or scope.

How will leviathan expand—temporarily and then permanently via the ratchet effect—in response to COVID-19? It’s too early to make any definite predictions, but we can make educated guesses based on experience and our knowledge of how governments work.

First, we can expect that government controls on travel and assembly will tighten. Whether via legislative approval, unilateral executive action, or judicial decree, the principle that governments must control movement and gatherings of people to prevent the spread of disease has been clearly established (or reestablished). As we know from Higgs’s work, the additional capabilities in this area acquired by the Centers for Disease Control and Prevention (CDC) and other agencies will likely be retained and put to use long after the crisis has abated. And further government intervention in the biomedical and healthcare sectors is virtually guaranteed.

The second likely long-term effect is ideological. Already we’re seeing the meme that the crisis has been caused (or at least exacerbated) by “neoliberalism”—that thanks to pervasive (?) libertarian ideology public health agencies were “hollowed out” and thus unable to respond in force:

Of course, we know that in the US the CDC initially prevented private labs from testing or developing new tests without FDA approval. More generally, public (and private) health in the US, as in most countries, operates within a tangled web of federal, state, and local regulations, subsidies, restrictions, and other controls.

It is impossible to know how a free market medical system would handle something like corona. But we will be told that there are no free market enthusiasts during a pandemic (and that, at best, those of us who favor property rights, markets, and prices should embrace “state capacity libertarianism”). The case for markets will have to be made, as Mises would say, ever more boldly.

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PPT - RUSSIAN ECONOMY PowerPoint Presentation - ID:1666640

 

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“FDA Approval” is a Monopolist’s Scheme to Limit Competition | Mises Institute

Posted by M. C. on August 16, 2018

FDA approval is also crucial because Medicaid and Medicare and Veterans will then pay for it. They will not pay for a supplement, even if it is the same thing, even if it costs less than a tenth as much.

https://mises.org/power-market/fda-approval-monopolists-scheme-limit-competition

Hunter Lewis

Charging the price of an expensive car for a garden-variety amino acid, one we eat every day.

A year ago, the Food and Drug Administration ( FDA) approved a “drug” called Endari to treat sickle cell disease, which afflicts about 100,000 Americans of African descent and around 25 million more outside the US. Price tag: $28,000 a year.

So what is Endari? Anything approved by the FDA legally becomes a “drug.” But some have noted this “drug” is just a higher dose of L-glutamine, a common amino acid that is in our food and that our bodies also make. Indeed, The agency itself describes this “drug”  as “L-glutamine oral powder.” Amino acids are the building blocks for protein and we also use them for other purposes. Read the rest of this entry »

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