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Pfizer Paid the Largest Criminal Fine in U.S. History

Pfizer Paid the Largest Criminal Fine in U.S. History—Lawsuit Details​

BY DANIELLE LETENYEI
AUG. 26 2021, PUBLISHED 2:43 P.M. ET

Getting full approval from the FDA for its COVID-19 vaccine is a big deal for Pfizer. The FDA-stamp of approval is a critical step in getting a drug to the market. If a pharmaceutical company starts promoting a drug for something that the FDA hasn’t okayed, it can get in big trouble.
In 2009, Pfizer agreed to pay $2.3 billion in a criminal and civil liability lawsuit stemming from the illegal promotion of certain drugs. At the time, it was the largest healthcare fraud settlement in history.
In 2012, healthcare giant GlaxoSmithKline (GSK) agreed to pay $3 billion in criminal and civil charges for the unlawful promotion of drugs like Paxil and Wellbutrin for uses that weren’t FDA approved. However, Pfizer still holds the record for receiving the largest criminal fine in history.

How FDA approval works for pharmaceutical companies​

Under provisions of the Food, Drug and Cosmetic Act enacted in 1938, the FDA approves pharmaceuticals for specific uses that a company identifies on its application. After the FDA approves the product as safe and effective for a specified use, a company’s marketing of its drugs must be limited to the FDA-approved use. Uses other than FDA-approved are considered “off-label uses,” and the FDA considers these “misbranded.”

Pfizer received the largest criminal fine in history.​

In Pfizer’s 2009 settlement, the company had to pay a criminal fine of $1.195 billion and its subsidiary Pharmacia & Upjohn Company Inc. had to forfeit $105 million, for a grand total of $1.3 billion. It's still the largest criminal fine ever imposed in the U.S.
The company pled guilty to felony charges or violating the Food, Drug and Cosmetic Act by misbranding the anti-inflammatory drug Bextra and promoting it for uses that the FDA “specifically declined to approved due to safety concerns,” the Department of Justice stated.
Pfizer also paid $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs—Bextra, anti-psychotic drug Geodon, antibiotic Zyvox, and anti-epileptic drug Lyrica. The settlement claims that Pfizer paid kickbacks to healthcare providers to entice them to prescribe the drugs.

Amazing what a simple Google Search will reveal. :unsure:
 

Jackalope

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Pain drugs Bextra and Celebrex proved to be particularly costly for Pfizer, with the drugmaker as recently as 2016 agreeing to shell out $486 milion to settle a long-running shareholder suit alleging Pfizer withheld information on the drugs’ cardiovascular risks.

Huh. Sounds familiar.
 

Wildlife

Denny
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People would be sick, disgusted or perhaps amazed if they knew just how much the markups are of drugs from manufacturers and those pharmacies that sell those drugs.

Just with Merck alone make enough in annual profits that would cover any of the fines stated in those articles very easily and it still wouldn't hurt them.

Back in the 90's, Merck's annual profits exceeded over 33 1/2 billion annually on a consistent bases. I know because I worked for them for 10 years at a high level as a IT person. It's disgusting and one of the reasons why I moved on from them. I can't even begin to tell you how many of their drugs or interactions have caused sever pain and/or death either. Part of my job was to diagnose nonconforming issues and even put forth any legal findings/testimonies if the organization was being sued and/or challenged by any legal entity.
 
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Tipmoose

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I'll still take their antibiotics when I have strep throat. We can rail against "big pharma" all we like, but without them a whole lot more of us would be dead.
 

Wildlife

Denny
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I'll still take their antibiotics when I have strep throat. We can rail against "big pharma" all we like, but without them a whole lot more of us would be dead.
I won't dispute that. I still take only what I have too, even so, that's a challenge. I try to stay as healthy as one can possibly do. In fact, one of Merck's drugs was a life changer for me, so yes, not all of big pharma drugs are bad. All I was trying to clarify is, they absolutely make tons of money annually, and they have that process down to a absolute science, even measuring their monies down to fractions of a penny. They don't miss nothing when it comes to making or losing money.
 
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Wildlife

Denny
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I'll add...

When a pharmaceutical company thinks their about to come up with a new drug for market, legal, regulatory, mathematicians and many other experts are at their disposal to figure every possible variable into that drug for profits sake, before it's introduced publicly, typically.

That is why they're all for vaccines because they are protected, and it's the future for them, to even make more profits. Quite simple really, but they have been working on that for a very long time.
 
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Jackalope

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I'll still take their antibiotics when I have strep throat. We can rail against "big pharma" all we like, but without them a whole lot more of us would be dead.

No doubt, but there is a massive problem with them covering things up and pushing drugs to expand beyond the group of people who actually need it. While taking it for strep is perfectly logical they have a history of telling people it's also good for a stubbed toe, paying doctor kickback for prescribing for a stubbed toe, and cover up the side effects of the known drugs.
 
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