Now I could be wrong on this, but from what I understand…
The FDA regulates manufactured pharmaceuticals (and can regulate interstate commerce of pharmaceuticals).
Between the various state boards and the US Pharmacopoeia, compounding of drugs by pharmacists is regulated.
So likely the FDA was never regulating this drug but leaving it up to the state boards until this year. There is a similar thing happening in the PET drug industry as well, without the granting of exclusivity.
Well, there is a hefty application fee, so it could have some trickle down effect on the budget, so if you don’t use the drug it might be a savings of a thousandth of a cent or some such to you.
I suspect how it is supposed to work is this: in order to get a licence for a new use for the drug, the company is supposed to provide evidence that the drug is, in fact, safe and effective for that use - meaning, typically, a bunch of (expensive) clinical trials.
They are then rewarded with a drug license, enabling them to market and sell the drug (and to charge a price so as to recoup their cash outlay for clinical trials, plus a profit).
How to prevent gouging? Well, here in Canada, that is done by government price controls, which establish a maximum allowable price for all patented drugs - the theory being that the grant of a patent (a government monopoly) should come with it the right to impose terms, such as limits on what may be charged for the patented items.
Heh- you wonder why the USA spends so much of its GDP on health.
Nasonex costs the NHS £7.40 for a 140-dose spray- I’ve just checked on the British National Formulary.
In England it would cost a patient £7.20 unless they were entitled to free prescriptions, in Northern Ireland, Scotland and Wales it would be free to everyone.
Even if you were to get it on a private prescription (say, as a non-UK resident) you’d only pay the private script fee plus £7.40- probably less than £15 altogether.
Why can the NHS get such a good deal when US taxpayers and insurance companies can’t?
Price gouging is putting it mildly.
Well, here in America, we do the same thing. We buy drugs with prices capped by Canada’s government.
Years ago our Senate voted to allow importation of “cheap” drugs from Canada, somehow without realizing that the only reason those drugs were cheap was that Canada passed a law to cap the prices.
Because if there were no financial incentive to continuing research on alternative uses of medication, that research would not be done and those uses would not be found. Price gouging monopolies have been granted to every drug company that ever gets a medication approved, I don’t know why suddenly everyone is so pissed off about this one. Is what they’re doing unethical? Whoa, stop the presses! Drug companies aren’t only concerned with bringing cheap and effective drugs to market? Sometimes they have shady business practices? Holy shit! :rolleyes:
The philosophical problem posed by drug prices is this: normally, the market would decide - but in order to encourage innovation, monopolies are granted; unfortunately, if there are no competing drugs, and the drug is truly a life-saver, the lucky company can then charge patients what they think their lives are worth - if there was no mechanism to control prices.
This of course affects healthcare costs generally, but it is particularly noticable with drug prices, as often the actual costs of manufacture are low.
The problem becomes more acute where governments, with the best of intentions, add sweeteners to encourage orphan drug development.
Nothing exceptional about it, they’re just giving us the business, as usual.
Except that KV did none of those things. It wasn’t an “alternative use” it was a well known use. They didn’t research squat. The taxpayers did that. You find it odd that folks are outraged whereas I find it odd that you wouldn’t be. Just because that’s “how pharma and the FDA do things” doesn’t make it right.
Dude, most of the research that leads to drug discovery is done by the NIH, and a lot of it is just plagiarized from previous research. Take Lipitor for example. It’s now being allowed to extend the patent because of a new indication to “prevent heart attacks in people with high cholesterol”. It was always a cholesterol med, but now it’s being used to “prevent heart attacks”. Shitty? Yes. But not so shocking because it’s not about “omg premature babies!!!”.
And it most certainly was an alternative use, meaning off-label, meaning not what it was approved by the FDA to do. Just because a shit ton of people used it for that does not change that fact. Nothing says the company itself has to do the research, it just says they have to present it and be the first to demonstrate efficacy for the indicated use. Seriously, I get why everybody is pissed off, but you’re all pissed off about something that happens every day, and you’re trying to put all of these shocking things out there when very few of you have any clue how this process works. If there were not financial incentives to discover new meds, and research additional uses of current meds, we would not have a drug industry. Part of these rules mean that if a bunch of people are using drugs for an off-patent use, and you realize this and submit a new drug application for that use, surprise! they get the patent rights.
It’s not really all that shocking, but far be it from me to inject some facts into everybody’s recreational outrage.
Even if I go through the health insurance I pay $600 bucks a month for, Nasonex carries
a $108.00 co-pay
Thank you for your reasoned and objective opinion. Now is my prescription ready yet or not?
Yes, but your copay went up $56,000.
As a Democrat, I apologize on behalf of my party for the 2006 initiative that led to this, passed under Democratic HHS secretary Mike Leavitt, who was appointed by Democratic president George W. Bush and confirmed by a Democratic-controlled Congress. We never should have done this. This is what happens when Democrats are in charge of any aspect of our health care system.
P.S.: This is the “Unapproved Drugs Initiative”, not the Orphan Drugs Act.
Apostate! Traitor to the Hive Mind! No Volvo for you!
Which is it?
One of the outrageous aspects of this case is that the company did ZERO research to find or justify this off label use. They paid some money to go through the application process, and the public is expected to pay them huge profits for doing so. Fuck that.
The second outrageous aspect of this is was already a cheap, commonly available generic that’s been in use for 50 years.
Third is the distastefulness of squeezing the hell out of people who are desperate. These guys want to make 99% profit off the backs of people who have no alternate product to use, and use the drug to protect the health of their unborn baby. You don’t want to deal with the “omg premature babies!” PR disasters, don’t choose to get into the premature baby drug business.
Normally, I’m a pro business type of guy, but these jokers must have broken out their Snidley Whiplash costumes when they concocted this business plan.
What the fuck? Nothing you have said influences the outrage one bit. The fact remains that a shitty company did something immoral, and they did so because the FDA allowed them to. It doesn’t matter one bit that they were following the law. If the law results in immorality, then it is immoral.
And it’s not the OPs fault that we wrote a stupid law that perverts what the word patent means. With every other use of the term, you have to prove there is no prior art. The point is to let you make money on something you created, that you put money in to research.
The law was created to provide an incentive for the company to do it’s own research. It was not created to let companies have a monopoly they did no work on. Why do you think the FDA is circumventing it?
Moral people get outraged about immorality, and try to fix it. The fact that it’s legal doesn’t factor in. The fact that you think it does says a hell of a lot about you, and none of it good.
Looks like they’ve reduced the price to ‘only’ $690.
I can imagine the conversation that started this little firestorm.
Pres: “Great! We’ve got the exclusive contract, let’s jack the cost to $500 a dose!”
Marketing: “Everybody will scream bloody murder if we do”
Pres: “Screw em. We’ve got the contract.”
Marketing: “Let’s do this instead. Tell them we’re going to charge them $1500, and then when they complain, we’ll cut it by half to $750. If they’re still too upset, we can step it back again.”
Pres: “Brilliant! Make it so!”
Pres: “Now scat. I’ve got to calculate the value of my stock options and bonus.”
Pres: “Oh. And have legal send cease and desist notices to all the pharmacies that can still make it for 20 bucks. Buncha fuckin leeches.”
For balance, we really need the “nothing is wrong if you can get away with it” perspective on this… now where’s that self-professed “tax lawyer” off to?