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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.
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.
I hope there are no lobbyists for the Oil Industry who hang at USMB.Um...to the OPer.
KV Pharmaceuticals is NOT "Big Pharma".
They had 325 employees and sales of only $152 M in 2010.
Um...to the OPer.
KV Pharmaceuticals is NOT "Big Pharma".
They had 325 employees and sales of only $152 M in 2010.
Oh, poor KV.
Only $152 million dollars to spread among 325 employees.
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!
Um...to the OPer.
KV Pharmaceuticals is NOT "Big Pharma".
They had 325 employees and sales of only $152 M in 2010.
Oh, poor KV.
Only $152 million dollars to spread among 325 employees.
Sales and profit are two different things.
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.
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.
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.
If KV was willing to scrape $30 billion out of the American Health Care Industry, what makes you think other labs weren't just as eagerly interested in the project?
Of course they were picked, and I'll bet $1.00 that the CEO was as giddy as a school-girl winning the science fair when he got the news and that he kissed his lobby-lawyer full on the mouth, but just as friends.
Um...to the OPer.
KV Pharmaceuticals is NOT "Big Pharma".
They had 325 employees and sales of only $152 M in 2010.
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.
It's not the government's job to set prices. It is, marginally, the government's job to ensure the safety of medications. And yes, as a matter of fucking fact, if Exxon was the only company mass-producing and distributing something, the government WOULD protect their intellectual property on the subject, whatever they charged.
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.
It's not the government's job to set prices. It is, marginally, the government's job to ensure the safety of medications. And yes, as a matter of fucking fact, if Exxon was the only company mass-producing and distributing something, the government WOULD protect their intellectual property on the subject, whatever they charged.
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.
No, believe ME, the FDA doesn't give a shit HOW cheap some PHARMACY (not pharmaceutical lab) can throw this together. What they care about is that they don't put their seal of approval on ANY drug that hasn't met their research standards, however much that costs. What, you think KV was DYING to go through all that time and hassle and expense? Oh, wait, of COURSE you do, because you have decided, in your infinite armchair wisdom, that every single cent of that increase is going right in their directors' pockets as profit, no expenses involved, despite having produced not a single fact supporting that.
No one ever said this was "newly discovered", genius. The article said it was newly approved by the FDA, something that it wasn't before. So either you're saying that cost makes the job of the FDA superfluous and we should disband them because their standards are too expensive to meet, or you're saying that we should discourage companies from taking on the job of mass-producing necessary medications and making them available to many, MANY more people by insisting that they can't recoup the cost of doing so.
You don't hear "low-income program to help the poor and uninsured afford the drug". You don't hear FDA approval. All you hear is that someone's making more money than you want them to, and you're on the warpath. Fuck all those women who might not have been able to get the drug at any price because there didn't happen to be a random pharmacy on hand that was willing to make the compound. Fuck the possible safety ramifications. Stick to the rich guys! That's all that matters!
Because it's an orphan drug, which are seldom researched by more than one company. But by all means, while you're adding to your hypothetical "evidence", why don't you find me some evidence that ANY other company was trying to achieve FDA approval for this compound? You can show it to me right after you show me evidence of KV's actual profit margin on this drug, AND evidence that KV donated money to any political campaign in the last election cycle.
The FDA does not "pick", and I don't care HOW much you want to see things your way. The bureaucracy works the way it works. The first company to meet the clinical and research standards for a medication gets the approval. Look it up, or add it to the evidence you have yet to provide me. I'm getting extremely tired of you telling me how things are based on "I just know that's how it works, because rich people are evil and in collusion!". Provide proof, or go eat your liver out in envy elsewhere.
Um...to the OPer.
KV Pharmaceuticals is NOT "Big Pharma".
They had 325 employees and sales of only $152 M in 2010.
They're rich. That's all that fucking matters. "Stick it to the fatcats! Who cares who gets hurt, as long as the rich fuckers get it!"
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.
It's not the government's job to set prices. It is, marginally, the government's job to ensure the safety of medications. And yes, as a matter of fucking fact, if Exxon was the only company mass-producing and distributing something, the government WOULD protect their intellectual property on the subject, whatever they charged.
That makes no sense to me, Cecilie. Are you speaking of some completely new product with a brand new patent, or are you saying that Exxon has a right to petition the government for a monopoly on petroleum production?
I'd like to go on record as being against that idea. It's bad enough having only 4 or 5 petroleum production companies competing for our business since the 'Merger-Madness' of the 1990's.
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.
It's not the government's job to set prices. It is, marginally, the government's job to ensure the safety of medications. And yes, as a matter of fucking fact, if Exxon was the only company mass-producing and distributing something, the government WOULD protect their intellectual property on the subject, whatever they charged.
There's no need to get vulgar.
I know its not the gov's job to set price, however; they are involving themselves in the process in that they are granting an exclusivity. So they are in. They have changed the paradigm.
With all of the angst over obama care and bending the cost curve the one thing obama cares does not appear to do, I see this as a huge contradiction to the spirit of what they are supposedly trying to do or claimed to have done.
