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Old 29th November 2021, 08:29 AM   #1
casebro
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Prescription drug costs, licensing fee, monopoly

Colchicine used to cost 10 cent/pill. But the FDA decided it needed to be tested and licensed, Price now $5.

]QUOTE] https://en.wikipedia.org/wiki/Colchicine "Oral colchicine had been used for many years as an unapproved drug with no FDA-approved prescribing information, dosage recommendations, or drug interaction warnings.[45] On 30 July 2009, the FDA approved colchicine as a monotherapy for the treatment of three different indications (familial Mediterranean fever, acute gout flares, and for the prophylaxis of gout flares[45]), and gave URL Pharma a three-year marketing exclusivity agreement[46] in exchange for URL Pharma doing 17 new studies and investing $100 million into the product, of which $45 million went to the FDA for the application fee. [/quote]

So half of the 100 million went to the FDA? Sound like institutional graft to anybody else?

AND, for that $45M, they got to patent an old drug for the same old use. Patent runs out in 2029. Generics are out there, but can not be sold for treating gout. IIRC, patents can not be granted for old ideas- least ways not for anything other than drugs. You can't patent the wheel barrow.
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Last edited by casebro; 29th November 2021 at 08:39 AM.
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Old 29th November 2021, 08:46 AM   #2
theprestige
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Originally Posted by casebro View Post
So half of the 100 million went to the FDA? Sound like institutional graft to anybody else?
Sounds like it to me, but cui bono? The FDA isn't a privately-held for-profit company. That $45 million isn't lining the pockets of some fat cat like Elon Musk or Jeff Bezos. And it's not like the FDA directors get together after hours and split the day's take amongst themselves. It's a government agency. The money is presumably tracked and accounted for. Did Congress order these fees? If so the legislators who voted in favor probably aren't going to see a dime of them. Did the president? Him neither, and anyway what happens when he leaves office?

---

The best I can imagine is a cabal of high-ranking FDA administrators, colluding to embezzle agency funds, and then drum up business like this to mask the budget shortfall. But that doesn't explain why the fee was instituted in the first place, and what the legislators or others who instituted it thought they were doing at the time.
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Old 29th November 2021, 09:20 AM   #3
Darat
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Originally Posted by casebro View Post
Colchicine used to cost 10 cent/pill. But the FDA decided it needed to be tested and licensed, Price now $5. ….
Nope, USA legislators decided it needed to be tested, the FDA is the government body that oversees such approvals.

Really not sure what your complaint is about? It appears USA legislators passed two pieces of legislation you object to?

Plus of course this only applies to the USA.
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Old 29th November 2021, 09:26 AM   #4
theprestige
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Originally Posted by Darat View Post
Nope, USA legislators decided it needed to be tested, the FDA is the government body that oversees such approvals.

Really not sure what your complaint is about? It appears USA legislators passed two pieces of legislation you object to?

Plus of course this only applies to the USA.
According to the linked Wikipedia article, it looks very much like this decision originated with the FDA, not with Congress. It looks like the law requires approval for new drugs, but gives the FDA discretion when it comes to preexisting unapproved drugs.

https://www.fda.gov/drugs/enforcemen...approved-drugs
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Old 29th November 2021, 02:44 PM   #5
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Originally Posted by casebro View Post
Colchicine used to cost 10 cent/pill. But the FDA decided it needed to be tested and licensed, Price now $5.

]QUOTE] https://en.wikipedia.org/wiki/Colchicine "Oral colchicine had been used for many years as an unapproved drug with no FDA-approved prescribing information, dosage recommendations, or drug interaction warnings.[45] On 30 July 2009, the FDA approved colchicine as a monotherapy for the treatment of three different indications (familial Mediterranean fever, acute gout flares, and for the prophylaxis of gout flares[45]), and gave URL Pharma a three-year marketing exclusivity agreement[46] in exchange for URL Pharma doing 17 new studies and investing $100 million into the product, of which $45 million went to the FDA for the application fee.
So half of the 100 million went to the FDA? Sound like institutional graft to anybody else?

AND, for that $45M, they got to patent an old drug for the same old use. Patent runs out in 2029. Generics are out there, but can not be sold for treating gout. IIRC, patents can not be granted for old ideas- least ways not for anything other than drugs. You can't patent the wheel barrow.[/quote]

Wheelbarrow Inc. in league with U.S. Government: "Hold our beer!"
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Old 29th November 2021, 10:55 PM   #6
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The patents do not cover anything that was known in the art prior to the filing date. They seem to cover combinations with other active ingredients or use in certain previously unknown ways to improve efficacy.

The likely problem for generics is that the fda approved one of these new formulations or methods of using this old drug. So the old usage is not fda approved. While the new usage is patented.

But I’m not a pharma person, so I could be wrong.
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Old 29th November 2021, 10:58 PM   #7
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Because of the revolving door between Pharma and the FDA, I would not at all be surprised if the agency did things that profit the industry more than the patients.
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Old 30th November 2021, 12:56 AM   #8
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Originally Posted by theprestige View Post
According to the linked Wikipedia article, it looks very much like this decision originated with the FDA, not with Congress. It looks like the law requires approval for new drugs, but gives the FDA discretion when it comes to preexisting unapproved drugs.

https://www.fda.gov/drugs/enforcemen...approved-drugs
Those powers did not one day appear creatio ex nihilo - who gave the FDA such powers?

Looking at the toxicology of the drug I would have thought that most people would be OK with the idea of it being tested with modern protocols. Obviously that could be done in a cack-handed manner which I think is casebro’s point?
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Old 30th November 2021, 06:10 AM   #9
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I think that the company is not patenting the drug, but has an exclusive marketing authority. The idea of a patent is to avoid a monopoly by making the knowledge of the invention open to all, but rewarding innovation by requiring people to pay a fee top the patent holder if they want to market their own version of the invention. Exclusive marketing authority has the opposite intention by deliberately creating a monopoly, but only within the US. My guess is the price charged is probably limited, and designed to cover the costs of putting the drug through modern licensing requirements. This may be particularly important for Familial Mediterranean Fever which is an orphan disease. Overall this is probably a good idea, colchicine is quite a toxic drug and essentially the drug company are being paid to produce the quality of evidence of effectiveness that would be required for a modern drug.
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