Big Pharma pigs out

[Quantum Windbag]

The government grants intellectual property rights every day, hundreds or thousands of times. In fact, there would be no market without granting such rights.

Quite true, but that is not what they did. They took a drug that was not the sole property of any single drug company and imposed restrictions on its manufacture, limiting it to one plant. The fact that anyone thought this was a good idea shows how stupid government in general is.

Limiting it to one plant drove the marginal costs up by a factor of 150?

I did not say that. What I said is that the government is stupid.

 

[Cecilie1200]

no one is demanding anyone give anything away...simply wondering why something that cost 10 bucks is now 1500 bucks, for no reason other than greed.

Well, here's ONE good reason, from dipshit's own link:

To get FDA approval, the company is spending hundreds of millions of dollars in additional research, including an international study involving 1,700 women.

I'm going to guess that, like with any newly-approved drug, the company is charging an initially high price to recoup the costs of the research and approval process.

Are you suggesting that we should do away with FDA approval and regulation of drugs in order to make them cost less?

Another thing that dipshit didn't bother to mention, also from his own fucking link:

The Ther-Rx patient assistance program promises free injections or much reduced prices based on income. Uninsured households making less than $100,000 are eligible for a copay of $20 or less.

Yeah, sounds really greedy and heartless.

 

[Cecilie1200]

This is the tell-tale line from the story:

But recently, KV Pharmaceutical of suburban St.Louis won government approval to exclusively sell the drug,​

Skull Pilot is right. All things being EQUAL, the market sets the price, but when the government creates an exclusive dealer, the government is setting the price.

If it was quality standards that they wanted, why didn't they just legislate a standard of quality that competing pharmaceutical companies would have to achieve?

Because it wasn't being produced by pharmaceutical companies at all. It was being mixed in pharmacies themselves.

The reason the FDA gave them exclusive approval for seven years - which is all they got - is the same reason they give exclusive approval to any company: KV is the one that spent the hundreds of millions of dollars on research to make sure the compound was safe to use and met FDA standards.

Would you rather do away with the FDA as an unnecessary expense on drug development and production?

 

[Cecilie1200]

Maybe people who can't have a child without extensive medical intervention should consider adoption instead of demanding that companies just give their goods away.

This might be news to you, but the need for this drug isn't necessarily known before someone becomes pregnant.

So, maybe EVERYBODY could adopt. Problem solved!

Actually, the drug is only indicated for women who are having a single-child pregnancy and who have already had a child prematurely prior to this pregnancy.

 

[Cecilie1200]

The government grants intellectual property rights every day, hundreds or thousands of times. In fact, there would be no market without granting such rights.

Quite true, but that is not what they did. They took a drug that was not the sole property of any single drug company and imposed restrictions on its manufacture, limiting it to one plant. The fact that anyone thought this was a good idea shows how stupid government in general is.

Limiting it to one plant drove the marginal costs up by a factor of 150?

Given that FDA approval requires hundreds of millions of dollars of research and clinical trials? Yeah.

 

[Trajan]

If I recall big pharma decided to fund the pro obama-care advertisements to the tune of 150 million dollars....hummm.

its the same old story, when the gov. sits down to mess with your Bus., if you are not at the table, you are on the menu.

So they decided to take a chair and here we are, payback time.


The WH switchboard can be reached at- 202-456-1414.

 

[AVG-JOE]

So even though a woman can't naturally carry to term she shouldn't be allowed to miscarry and a company has the obligation to supply cheap drugs?

She shouldn't be allowed to miscarry? She has every right to miscarry.

But if cheap drugs can prevent a miscarriage then a private company has the obligation to provide them right?

After all that is what this thread was about.

A private company shouldn't have an obligation in as much as an opportunity.

And ANY company that's willing to invest in the infrastructure required to produce a product to the standards that We, The People dictate, should have the opportunity to see what they can sell it for.

"Should We, The People provide the drug to folks who can't afford it?" is a different question...... But doesn't it make sense to have multiple organizations vying for the business that takes up so much of our budget?

Shit, when I get new mud shoes for the dogs Jeep, I get at least 2 estimates... Competition works - Sweet-heart deals using other peoples money, not so much.

 

[AVG-JOE]

This is the tell-tale line from the story:

But recently, KV Pharmaceutical of suburban St.Louis won government approval to exclusively sell the drug,​

Skull Pilot is right. All things being EQUAL, the market sets the price, but when the government creates an exclusive dealer, the government is setting the price.

If it was quality standards that they wanted, why didn't they just legislate a standard of quality that competing pharmaceutical companies would have to achieve?

The government grants intellectual property rights every day, hundreds or thousands of times. In fact, there would be no market without granting such rights.

Quite true, but that is not what they did. They took a drug that was not the sole property of any single drug company and imposed restrictions on its manufacture, limiting it to one plant. The fact that anyone thought this was a good idea shows how stupid government in general is.

The reason "Government" sucks for the average Joe is not because it's STUPID - Government sucks because it's profitable, and them that have the rivers of cash-flow flowing their direction are NOT going to relinquish those rivers or the government that helps them hold them with out a fight.

Government is a tool and currently that tool is available to the highest bidders.

 

[AVG-JOE]

This is the tell-tale line from the story:

But recently, KV Pharmaceutical of suburban St.Louis won government approval to exclusively sell the drug,​

Skull Pilot is right. All things being EQUAL, the market sets the price, but when the government creates an exclusive dealer, the government is setting the price.

If it was quality standards that they wanted, why didn't they just legislate a standard of quality that competing pharmaceutical companies would have to achieve?

Because it wasn't being produced by pharmaceutical companies at all. It was being mixed in pharmacies themselves.

The reason the FDA gave them exclusive approval for seven years - which is all they got - is the same reason they give exclusive approval to any company: KV is the one that spent the hundreds of millions of dollars on research to make sure the compound was safe to use and met FDA standards.

Would you rather do away with the FDA as an unnecessary expense on drug development and production?

Also from the article:

None of them anticipated the dramatic price hike, though — especially since most of the cost for development and research was shouldered by others in the past.​

Does anyone know what's actually going on with this deal? It looked to this average Joe that a pharma production plant got a sweet-heart deal exclusively producing an already proven compound to prescribed standards and they were taking advantage.

From another article: Price of Preventing Premature Births Skyrockets With New Drug - ABC News

Although the shot has been available in unregulated form from specialty compounding pharmacies for years for $10 a pop, the Food and Drug Administration recently granted KV Pharmaceuticals sole rights to produce the drug, which will be marketed as Makena and cost $1,500 per dose -- an estimated $30,000 in total per pregnancy.

"Progesterone is so cheap to make and we never had a problem with the compounding pharmacies making it. There's probably some variation between pharmacies, which nobody likes, but nobody likes $1,500 a shot either. That seems like highway robbery," says Dr. Jacques Moritz, director of gynecology at St. Luke's-Roosevelt Hospital in New York.​

Still sounds like a nice return on investment for those campaign dollar$ $weet-heart deal to me.

 

[Cecilie1200]

This is the tell-tale line from the story:

But recently, KV Pharmaceutical of suburban St.Louis won government approval to exclusively sell the drug,​

Skull Pilot is right. All things being EQUAL, the market sets the price, but when the government creates an exclusive dealer, the government is setting the price.

If it was quality standards that they wanted, why didn't they just legislate a standard of quality that competing pharmaceutical companies would have to achieve?

Because it wasn't being produced by pharmaceutical companies at all. It was being mixed in pharmacies themselves.

The reason the FDA gave them exclusive approval for seven years - which is all they got - is the same reason they give exclusive approval to any company: KV is the one that spent the hundreds of millions of dollars on research to make sure the compound was safe to use and met FDA standards.

Would you rather do away with the FDA as an unnecessary expense on drug development and production?

Also from the article:

None of them anticipated the dramatic price hike, though — especially since most of the cost for development and research was shouldered by others in the past.​

Does anyone know what's actually going on with this deal? It looked to this average Joe that a pharma production plant got a sweet-heart deal exclusively producing an already proven compound to prescribed standards and they were taking advantage.

Then you didn't read very closely. The cost of development and research WASN'T shouldered in the past, because it had never been approved by the FDA. KV was required to do hundreds of millions of dollars worth of VERIFIED research and trials in order to qualify. And although there had been no complaints that anyone knew about - or mentioned - concerning quality and consistency, that's far from saying all the production was up to FDA-prescribed standards, or reliable.

The FDA has certain requirements that must be met, and certain things that must be provided. However much this compound had been used in the past, if the documented research wasn't available - and obviously, it wasn't - then KV had to do it again so they could provide it.

From another article: Price of Preventing Premature Births Skyrockets With New Drug - ABC News

Although the shot has been available in unregulated form from specialty compounding pharmacies for years for $10 a pop, the Food and Drug Administration recently granted KV Pharmaceuticals sole rights to produce the drug, which will be marketed as Makena and cost $1,500 per dose -- an estimated $30,000 in total per pregnancy.

"Progesterone is so cheap to make and we never had a problem with the compounding pharmacies making it. There's probably some variation between pharmacies, which nobody likes, but nobody likes $1,500 a shot either. That seems like highway robbery," says Dr. Jacques Moritz, director of gynecology at St. Luke's-Roosevelt Hospital in New York.​

Still sounds like a nice return on investment for those campaign dollar$ $weet-heart deal to me.

How do you know KV donated ANYTHING to any campaign? Got proof?

Furthermore, how do you know how much of an actual profit margin they'll be making in the seven years that they're the sole FDA-authorized producer of Makena? Got any hard evidence that it's any greater percentage than the pharmaceutical industry makes on any orphan drug, which is a lot lower than the standard profit margin for most industries?

 

[Skull Pilot]

She shouldn't be allowed to miscarry? She has every right to miscarry.

But if cheap drugs can prevent a miscarriage then a private company has the obligation to provide them right?

After all that is what this thread was about.

No, they have no obligation to provide them.

Nor does the government have any obligation to protect their intellectual property.

This has nothing to do with patent laws.

 

[AVG-JOE]

Because it wasn't being produced by pharmaceutical companies at all. It was being mixed in pharmacies themselves.

The reason the FDA gave them exclusive approval for seven years - which is all they got - is the same reason they give exclusive approval to any company: KV is the one that spent the hundreds of millions of dollars on research to make sure the compound was safe to use and met FDA standards.

Would you rather do away with the FDA as an unnecessary expense on drug development and production?

Also from the article:

None of them anticipated the dramatic price hike, though — especially since most of the cost for development and research was shouldered by others in the past.​

Does anyone know what's actually going on with this deal? It looked to this average Joe that a pharma production plant got a sweet-heart deal exclusively producing an already proven compound to prescribed standards and they were taking advantage.

Then you didn't read very closely. The cost of development and research WASN'T shouldered in the past, because it had never been approved by the FDA. KV was required to do hundreds of millions of dollars worth of VERIFIED research and trials in order to qualify. And although there had been no complaints that anyone knew about - or mentioned - concerning quality and consistency, that's far from saying all the production was up to FDA-prescribed standards, or reliable.

The FDA has certain requirements that must be met, and certain things that must be provided. However much this compound had been used in the past, if the documented research wasn't available - and obviously, it wasn't - then KV had to do it again so they could provide it.

From another article: Price of Preventing Premature Births Skyrockets With New Drug - ABC News

Although the shot has been available in unregulated form from specialty compounding pharmacies for years for $10 a pop, the Food and Drug Administration recently granted KV Pharmaceuticals sole rights to produce the drug, which will be marketed as Makena and cost $1,500 per dose -- an estimated $30,000 in total per pregnancy.

"Progesterone is so cheap to make and we never had a problem with the compounding pharmacies making it. There's probably some variation between pharmacies, which nobody likes, but nobody likes $1,500 a shot either. That seems like highway robbery," says Dr. Jacques Moritz, director of gynecology at St. Luke's-Roosevelt Hospital in New York.​

Still sounds like a nice return on investment for those campaign dollar$ $weet-heart deal to me.

How do you know KV donated ANYTHING to any campaign? Got proof?

Furthermore, how do you know how much of an actual profit margin they'll be making in the seven years that they're the sole FDA-authorized producer of Makena? Got any hard evidence that it's any greater percentage than the pharmaceutical industry makes on any orphan drug, which is a lot lower than the standard profit margin for most industries?

Like I said, From reading BOTH articles it sounds like someone got a sweet-heart deal to exclusively produce a compound that has already been formulated by the market.

These clowns are getting paid a fortune to reinvent the wheel.

 

[Trajan]

Because it wasn't being produced by pharmaceutical companies at all. It was being mixed in pharmacies themselves.

The reason the FDA gave them exclusive approval for seven years - which is all they got - is the same reason they give exclusive approval to any company: KV is the one that spent the hundreds of millions of dollars on research to make sure the compound was safe to use and met FDA standards.

Would you rather do away with the FDA as an unnecessary expense on drug development and production?

Also from the article:

None of them anticipated the dramatic price hike, though — especially since most of the cost for development and research was shouldered by others in the past.​

Does anyone know what's actually going on with this deal? It looked to this average Joe that a pharma production plant got a sweet-heart deal exclusively producing an already proven compound to prescribed standards and they were taking advantage.

Then you didn't read very closely. The cost of development and research WASN'T shouldered in the past, because it had never been approved by the FDA. KV was required to do hundreds of millions of dollars worth of VERIFIED research and trials in order to qualify. And although there had been no complaints that anyone knew about - or mentioned - concerning quality and consistency, that's far from saying all the production was up to FDA-prescribed standards, or reliable.

The FDA has certain requirements that must be met, and certain things that must be provided. However much this compound had been used in the past, if the documented research wasn't available - and obviously, it wasn't - then KV had to do it again so they could provide it.

From another article: Price of Preventing Premature Births Skyrockets With New Drug - ABC News

Although the shot has been available in unregulated form from specialty compounding pharmacies for years for $10 a pop, the Food and Drug Administration recently granted KV Pharmaceuticals sole rights to produce the drug, which will be marketed as Makena and cost $1,500 per dose -- an estimated $30,000 in total per pregnancy.

"Progesterone is so cheap to make and we never had a problem with the compounding pharmacies making it. There's probably some variation between pharmacies, which nobody likes, but nobody likes $1,500 a shot either. That seems like highway robbery," says Dr. Jacques Moritz, director of gynecology at St. Luke's-Roosevelt Hospital in New York.​

Still sounds like a nice return on investment for those campaign dollar$ $weet-heart deal to me.

How do you know KV donated ANYTHING to any campaign? Got proof?

Furthermore, how do you know how much of an actual profit margin they'll be making in the seven years that they're the sole FDA-authorized producer of Makena? Got any hard evidence that it's any greater percentage than the pharmaceutical industry makes on any orphan drug, which is a lot lower than the standard profit margin for most industries?

good post thank you. your questions are apt. And I have tried goggling KV Pharmaceuticals and finding a link that say they directly contributed to the basket of money that pharma used to fund obama care ads, all I have found ifs that their PHARMACEUTICAL/DIRECTOR OF MARKETING gave 300 bucks to hillary and their PHARMACEUTICAL/VICE PRESIDENT OF ??? gave 300 to obama. They have 2 subsidiaries Nesher and Ther- RX, I cannot get information directly on them.

However thats not the way it works, they can give to orgs. that are not PAC's that allows a certian amount of any anonymity. *shrugs*


Apparently KV has had other issues making me wonder why they were chosen as an exclusive supplier......KV Pharmaceuticals – Long Time Problems with Issues - Quality Control, The FDA, and The Family – Will The One Time T - Wellsphere


In any event, we are supposed to be bending the cost curve down not upward. The gov. decides to pick a winner, there by creating losers and the price skyrockets? Who holds the patent on this compound by the way?

If the compound is so easy and relatively cheap to make, why choose an exclusive, put it out to bid , buy wholesale , a promised number of units and let the market take care of it. This reminds me of Roosevelt's Agricultural Adjustment Act in that we had ranchers killing live stock and farmers plowing over arable land, while people in urban areas were starving......unreal. Any time the gov. gets its hands into the process, little good happens.

 

[Cecilie1200]

Also from the article:

None of them anticipated the dramatic price hike, though — especially since most of the cost for development and research was shouldered by others in the past.​

Does anyone know what's actually going on with this deal? It looked to this average Joe that a pharma production plant got a sweet-heart deal exclusively producing an already proven compound to prescribed standards and they were taking advantage.

Then you didn't read very closely. The cost of development and research WASN'T shouldered in the past, because it had never been approved by the FDA. KV was required to do hundreds of millions of dollars worth of VERIFIED research and trials in order to qualify. And although there had been no complaints that anyone knew about - or mentioned - concerning quality and consistency, that's far from saying all the production was up to FDA-prescribed standards, or reliable.

The FDA has certain requirements that must be met, and certain things that must be provided. However much this compound had been used in the past, if the documented research wasn't available - and obviously, it wasn't - then KV had to do it again so they could provide it.

From another article: Price of Preventing Premature Births Skyrockets With New Drug - ABC News

Although the shot has been available in unregulated form from specialty compounding pharmacies for years for $10 a pop, the Food and Drug Administration recently granted KV Pharmaceuticals sole rights to produce the drug, which will be marketed as Makena and cost $1,500 per dose -- an estimated $30,000 in total per pregnancy.

"Progesterone is so cheap to make and we never had a problem with the compounding pharmacies making it. There's probably some variation between pharmacies, which nobody likes, but nobody likes $1,500 a shot either. That seems like highway robbery," says Dr. Jacques Moritz, director of gynecology at St. Luke's-Roosevelt Hospital in New York.​

Still sounds like a nice return on investment for those campaign dollar$ $weet-heart deal to me.

How do you know KV donated ANYTHING to any campaign? Got proof?

Furthermore, how do you know how much of an actual profit margin they'll be making in the seven years that they're the sole FDA-authorized producer of Makena? Got any hard evidence that it's any greater percentage than the pharmaceutical industry makes on any orphan drug, which is a lot lower than the standard profit margin for most industries?

Like I said, From reading BOTH articles it sounds like someone got a sweet-heart deal to exclusively produce a compound that has already been formulated by the market.

These clowns are getting paid a fortune to reinvent the wheel.

These "clowns" are mass-producing, standardizing quality of, and making more widely available a helpful orphan drug that previously you could only get from random pharmacies that might be willing to mix the compound for you. They've started a program to help poor women be able to continue to afford the treatment. And you want to piss and moan because they DARE to try to recoup the costs, without any real evidence other than a highly subjective and one-sided article.

Good job.

 

[Cecilie1200]

Also from the article:

None of them anticipated the dramatic price hike, though — especially since most of the cost for development and research was shouldered by others in the past.​

Does anyone know what's actually going on with this deal? It looked to this average Joe that a pharma production plant got a sweet-heart deal exclusively producing an already proven compound to prescribed standards and they were taking advantage.

Then you didn't read very closely. The cost of development and research WASN'T shouldered in the past, because it had never been approved by the FDA. KV was required to do hundreds of millions of dollars worth of VERIFIED research and trials in order to qualify. And although there had been no complaints that anyone knew about - or mentioned - concerning quality and consistency, that's far from saying all the production was up to FDA-prescribed standards, or reliable.

The FDA has certain requirements that must be met, and certain things that must be provided. However much this compound had been used in the past, if the documented research wasn't available - and obviously, it wasn't - then KV had to do it again so they could provide it.

From another article: Price of Preventing Premature Births Skyrockets With New Drug - ABC News

Although the shot has been available in unregulated form from specialty compounding pharmacies for years for $10 a pop, the Food and Drug Administration recently granted KV Pharmaceuticals sole rights to produce the drug, which will be marketed as Makena and cost $1,500 per dose -- an estimated $30,000 in total per pregnancy.

"Progesterone is so cheap to make and we never had a problem with the compounding pharmacies making it. There's probably some variation between pharmacies, which nobody likes, but nobody likes $1,500 a shot either. That seems like highway robbery," says Dr. Jacques Moritz, director of gynecology at St. Luke's-Roosevelt Hospital in New York.​

Still sounds like a nice return on investment for those campaign dollar$ $weet-heart deal to me.

How do you know KV donated ANYTHING to any campaign? Got proof?

Furthermore, how do you know how much of an actual profit margin they'll be making in the seven years that they're the sole FDA-authorized producer of Makena? Got any hard evidence that it's any greater percentage than the pharmaceutical industry makes on any orphan drug, which is a lot lower than the standard profit margin for most industries?

good post thank you. your questions are apt. And I have tried goggling KV Pharmaceuticals and finding a link that say they directly contributed to the basket of money that pharma used to fund obama care ads, all I have found ifs that their PHARMACEUTICAL/DIRECTOR OF MARKETING gave 300 bucks to hillary and their PHARMACEUTICAL/VICE PRESIDENT OF ??? gave 300 to obama. They have 2 subsidiaries Nesher and Ther- RX, I cannot get information directly on them.

However thats not the way it works, they can give to orgs. that are not PAC's that allows a certian amount of any anonymity. *shrugs*


Apparently KV has had other issues making me wonder why they were chosen as an exclusive supplier......KV Pharmaceuticals – Long Time Problems with Issues - Quality Control, The FDA, and The Family – Will The One Time T - Wellsphere


In any event, we are supposed to be bending the cost curve down not upward. The gov. decides to pick a winner, there by creating losers and the price skyrockets? Who holds the patent on this compound by the way?

If the compound is so easy and relatively cheap to make, why choose an exclusive, put it out to bid , buy wholesale , a promised number of units and let the market take care of it. This reminds me of Roosevelt's Agricultural Adjustment Act in that we had ranchers killing live stock and farmers plowing over arable land, while people in urban areas were starving......unreal. Any time the gov. gets its hands into the process, little good happens.

I don't think anyone holds a patent on it, that I can tell.

You all keep saying "chosen", and "picked", as though the government went out looking for someone to mass-produce and distribute this compound. That's not how the process works. It would be KV who decided they wanted to get FDA approval for this compound, and it was KV who decided to spend the money to to work it through the process.

 

[Trajan]

Then you didn't read very closely. The cost of development and research WASN'T shouldered in the past, because it had never been approved by the FDA. KV was required to do hundreds of millions of dollars worth of VERIFIED research and trials in order to qualify. And although there had been no complaints that anyone knew about - or mentioned - concerning quality and consistency, that's far from saying all the production was up to FDA-prescribed standards, or reliable.

The FDA has certain requirements that must be met, and certain things that must be provided. However much this compound had been used in the past, if the documented research wasn't available - and obviously, it wasn't - then KV had to do it again so they could provide it.



How do you know KV donated ANYTHING to any campaign? Got proof?

Furthermore, how do you know how much of an actual profit margin they'll be making in the seven years that they're the sole FDA-authorized producer of Makena? Got any hard evidence that it's any greater percentage than the pharmaceutical industry makes on any orphan drug, which is a lot lower than the standard profit margin for most industries?

good post thank you. your questions are apt. And I have tried goggling KV Pharmaceuticals and finding a link that say they directly contributed to the basket of money that pharma used to fund obama care ads, all I have found ifs that their PHARMACEUTICAL/DIRECTOR OF MARKETING gave 300 bucks to hillary and their PHARMACEUTICAL/VICE PRESIDENT OF ??? gave 300 to obama. They have 2 subsidiaries Nesher and Ther- RX, I cannot get information directly on them.

However thats not the way it works, they can give to orgs. that are not PAC's that allows a certian amount of any anonymity. *shrugs*


Apparently KV has had other issues making me wonder why they were chosen as an exclusive supplier......KV Pharmaceuticals – Long Time Problems with Issues - Quality Control, The FDA, and The Family – Will The One Time T - Wellsphere


In any event, we are supposed to be bending the cost curve down not upward. The gov. decides to pick a winner, there by creating losers and the price skyrockets? Who holds the patent on this compound by the way?

If the compound is so easy and relatively cheap to make, why choose an exclusive, put it out to bid , buy wholesale , a promised number of units and let the market take care of it. This reminds me of Roosevelt's Agricultural Adjustment Act in that we had ranchers killing live stock and farmers plowing over arable land, while people in urban areas were starving......unreal. Any time the gov. gets its hands into the process, little good happens.

I don't think anyone holds a patent on it, that I can tell.

You all keep saying "chosen", and "picked", as though the government went out looking for someone to mass-produce and distribute this compound. That's not how the process works. It would be KV who decided they wanted to get FDA approval for this compound, and it was KV who decided to spend the money to to work it through the process.

I believe I did make a reference to BID.

IF the gov. is going to award an exclusive, then thats the least they could do before awarding such....*shrugs*.

 

[Cecilie1200]

good post thank you. your questions are apt. And I have tried goggling KV Pharmaceuticals and finding a link that say they directly contributed to the basket of money that pharma used to fund obama care ads, all I have found ifs that their PHARMACEUTICAL/DIRECTOR OF MARKETING gave 300 bucks to hillary and their PHARMACEUTICAL/VICE PRESIDENT OF ??? gave 300 to obama. They have 2 subsidiaries Nesher and Ther- RX, I cannot get information directly on them.

However thats not the way it works, they can give to orgs. that are not PAC's that allows a certian amount of any anonymity. *shrugs*


Apparently KV has had other issues making me wonder why they were chosen as an exclusive supplier......KV Pharmaceuticals – Long Time Problems with Issues - Quality Control, The FDA, and The Family – Will The One Time T - Wellsphere


In any event, we are supposed to be bending the cost curve down not upward. The gov. decides to pick a winner, there by creating losers and the price skyrockets? Who holds the patent on this compound by the way?

If the compound is so easy and relatively cheap to make, why choose an exclusive, put it out to bid , buy wholesale , a promised number of units and let the market take care of it. This reminds me of Roosevelt's Agricultural Adjustment Act in that we had ranchers killing live stock and farmers plowing over arable land, while people in urban areas were starving......unreal. Any time the gov. gets its hands into the process, little good happens.

I don't think anyone holds a patent on it, that I can tell.

You all keep saying "chosen", and "picked", as though the government went out looking for someone to mass-produce and distribute this compound. That's not how the process works. It would be KV who decided they wanted to get FDA approval for this compound, and it was KV who decided to spend the money to to work it through the process.

I believe I did make a reference to BID.

IF the gov. is going to award an exclusive, then thats the least they could do before awarding such....*shrugs*.

FDA approval isn't like defense contracts. The government doesn't initiate FDA approval, like they announce, "We want someone to produce XYZ drug," and then a bunch of companies submit estimates and they pick one.

KV decided they wanted to mass-produce this compound with FDA approval. I haven't seen any indication anyone else wanted to do so at all. They produced the documentation for the FDA standards, the FDA said, "Okay, this looks up to snuff, we'll let you produce and sell it". And the FDA will not approve anyone else to mass-produce and distribute this compound for seven years, which is also pretty standard in pharmaceuticals, as far as I can tell, although when one is talking about NEW drugs, there is usually a patent involved.

 

[AVG-JOE]

Also from the article:

None of them anticipated the dramatic price hike, though — especially since most of the cost for development and research was shouldered by others in the past.​

Does anyone know what's actually going on with this deal? It looked to this average Joe that a pharma production plant got a sweet-heart deal exclusively producing an already proven compound to prescribed standards and they were taking advantage.

Then you didn't read very closely. The cost of development and research WASN'T shouldered in the past, because it had never been approved by the FDA. KV was required to do hundreds of millions of dollars worth of VERIFIED research and trials in order to qualify. And although there had been no complaints that anyone knew about - or mentioned - concerning quality and consistency, that's far from saying all the production was up to FDA-prescribed standards, or reliable.

The FDA has certain requirements that must be met, and certain things that must be provided. However much this compound had been used in the past, if the documented research wasn't available - and obviously, it wasn't - then KV had to do it again so they could provide it.

From another article: Price of Preventing Premature Births Skyrockets With New Drug - ABC News

Although the shot has been available in unregulated form from specialty compounding pharmacies for years for $10 a pop, the Food and Drug Administration recently granted KV Pharmaceuticals sole rights to produce the drug, which will be marketed as Makena and cost $1,500 per dose -- an estimated $30,000 in total per pregnancy.

"Progesterone is so cheap to make and we never had a problem with the compounding pharmacies making it. There's probably some variation between pharmacies, which nobody likes, but nobody likes $1,500 a shot either. That seems like highway robbery," says Dr. Jacques Moritz, director of gynecology at St. Luke's-Roosevelt Hospital in New York.​

Still sounds like a nice return on investment for those campaign dollar$ $weet-heart deal to me.

How do you know KV donated ANYTHING to any campaign? Got proof?

Furthermore, how do you know how much of an actual profit margin they'll be making in the seven years that they're the sole FDA-authorized producer of Makena? Got any hard evidence that it's any greater percentage than the pharmaceutical industry makes on any orphan drug, which is a lot lower than the standard profit margin for most industries?

good post thank you. your questions are apt. And I have tried goggling KV Pharmaceuticals and finding a link that say they directly contributed to the basket of money that pharma used to fund obama care ads, all I have found ifs that their PHARMACEUTICAL/DIRECTOR OF MARKETING gave 300 bucks to hillary and their PHARMACEUTICAL/VICE PRESIDENT OF ??? gave 300 to obama. They have 2 subsidiaries Nesher and Ther- RX, I cannot get information directly on them.

However thats not the way it works, they can give to orgs. that are not PAC's that allows a certian amount of any anonymity. *shrugs*


Apparently KV has had other issues making me wonder why they were chosen as an exclusive supplier......KV Pharmaceuticals – Long Time Problems with Issues - Quality Control, The FDA, and The Family – Will The One Time T - Wellsphere


In any event, we are supposed to be bending the cost curve down not upward. The gov. decides to pick a winner, there by creating losers and the price skyrockets? Who holds the patent on this compound by the way?

If the compound is so easy and relatively cheap to make, why choose an exclusive, put it out to bid , buy wholesale , a promised number of units and let the market take care of it. This reminds me of Roosevelt's Agricultural Adjustment Act in that we had ranchers killing live stock and farmers plowing over arable land, while people in urban areas were starving......unreal. Any time the gov. gets its hands into the process, little good happens.

With everything but the last line... Government does have a role - to set the minimum quality standards so nobody throws sawdust into the hamburger.

 

[Trajan]

and I would say after looking at the end user price point, that maybe they would like to exercise a little consumer advocacy, which they do on lots of others issues and see if there are any other interested parties.


if exxon said hey we can refine this special fuel, its going to be us only and heres the price we will ask and the fuel which many of us had to use would be $20 dollars a gallon, you think they'd get away with that? That the gov. would award them an exclusive? I don't think so.

 

[AVG-JOE]

Then you didn't read very closely. The cost of development and research WASN'T shouldered in the past, because it had never been approved by the FDA. KV was required to do hundreds of millions of dollars worth of VERIFIED research and trials in order to qualify. And although there had been no complaints that anyone knew about - or mentioned - concerning quality and consistency, that's far from saying all the production was up to FDA-prescribed standards, or reliable.

The FDA has certain requirements that must be met, and certain things that must be provided. However much this compound had been used in the past, if the documented research wasn't available - and obviously, it wasn't - then KV had to do it again so they could provide it.



How do you know KV donated ANYTHING to any campaign? Got proof?

Furthermore, how do you know how much of an actual profit margin they'll be making in the seven years that they're the sole FDA-authorized producer of Makena? Got any hard evidence that it's any greater percentage than the pharmaceutical industry makes on any orphan drug, which is a lot lower than the standard profit margin for most industries?

Like I said, From reading BOTH articles it sounds like someone got a sweet-heart deal to exclusively produce a compound that has already been formulated by the market.

These clowns are getting paid a fortune to reinvent the wheel.

These "clowns" are mass-producing, standardizing quality of, and making more widely available a helpful orphan drug that previously you could only get from random pharmacies that might be willing to mix the compound for you. They've started a program to help poor women be able to continue to afford the treatment. And you want to piss and moan because they DARE to try to recoup the costs, without any real evidence other than a highly subjective and one-sided article.

Good job.

Trust me Cecile, if pharmaceutical labs are willing to burn a batch of this goo at $10 a dose and folks out there in t.v. land are willing to force their insurance bureaucracies to pay $1,500 a dose, common ground for a competitive market needs only some sort of MINIMUM manufacturing standard for a recipie that sounds as common as fudge already.

Unless KV Pharm just invented this shit,

And I don't think either article even eludes to this being a newly discovered, in the human trials phase, substance.

This is the kind of shit that the drug industry lobby money that NOBODY denies is there is buying.