Big Pharma pigs out

[Cecilie1200]

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.

It's still o.k. to NOT like how the fucking thing is working right now, eh?

That's kind of the point to these political bitch-boards, ain't it?

Dislike whatever you want. I don't give a shit. Start making unsubstantiated declarations about how things are and how the world works based on your personal preferences, and you'll get cut off at the knees.

 

[Chris]

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.

It's still o.k. to NOT like how the fucking thing is working right now, eh?

That's kind of the point to these political bitch-boards, ain't it?

Dislike whatever you want. I don't give a shit. Start making unsubstantiated declarations about how things are and how the world works based on your personal preferences, and you'll get cut off at the knees.

I think you just described yourself.

 

[Trajan]

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.

The FDA has always had this ability. It's not my fault, or theirs, that you were unaware of it until now. Makena is the only FDA-approved compound on the market. It's kinda their job to make sure people get safe prescription drugs, isn't it?

Developing Products for Rare Diseases & Conditions

The FDA offers this protection for orphan drug manufacturers in order to encourage them to produce medications for conditions that are not common enough to be big money-makers, the way Viagra, for example, is. If they didn't, there would be a lot of rare and uncommon medical conditions that would get no attention from pharmaceutical companies at all, since they're businesses, not charities.

Makena is an orphan drug, which is why KV is getting exclusivity for a certain number of years.

thx for the link, I didn't see the explanation as to exclusivity for marketing, manufacturing and sale as a sole purveyor in there, can you direct me to it?