So apparently the FDA has just approved what was formerly an off-label use of progesterone to prevent premature births and gave KV Pharma the exclusive right to produce it (to ensure quality!)
So they decided to call this esoteric hormone Makema and jacked the price from 15 or 20 bucks per dose to $1,500.
Story here.
Presented with no comment - no comment at all.
Edit: Title should be KV Pharma. I was too flabbergasted to type correctly.
Yeah, i was reading about this a couple of weeks ago, but never got around to starting a thread about it.
It’s a pretty royally fucked-up situation. And it’s not like KB Pharam developed this drug out of their own skill and resources (which is one of the justifications for high drug prices); it’s been around for ages, and much of the early development was actually funded with tax dollars through the NIH. The only thing that’s changed is that they’ve been handed an artificial monopoly.
I’m mildly confused.
“Off-label” use implies that the drug was already available for other purposes. Who manufactured it? Is it old enough to have a generic available?
I’m also bewildered as to why the FDA felt it necessary to license to one manufacturer an already existing synthetic drug.
Something’s missing from this story. I don’t know what, but . . . something . . .
Off-label was my choice of words. It was my understanding that it had not been previously approved for this purpose before.
The drug had never been officially approved for this purpose, but had been mixed and dispensed for years by compounding pharmacies. The FDA move to approve an official version was, apparently, in the interests of ensuring quality control and uniformity.
During the process, a lot of doctors actually expressed some approval, not specifcallybecause they thought that the compound pharmacies had been dispensing bad products, but simply because they felt that FDA approval would be a good thing, and would officially ensure that minimum standards would be adhered to in producing the drug.
Many of these same doctors were horrified when, having been handed a monopoly, KV jacked up the price to 150 times its previous level.
As many of these doctors have since noted, the progesterone produced by compounding pharmacies worked great. Also, as i said in my previous post, KV didn’t even have to invest the sort of R&D money that most drug companies invest in a new product. This drug had been used for years, and subjected to tests previously. As one doctor in this article notes:
The company’s rationale for the price hike is also hilarious:
So, because this drug, which has been around for ages, can prevent premature birth, save people endless anguish, and save the health industry, government, and consumers millions of dollars, a company that didn’t even invent the thing can charge $1,500 per dose just because it has been handed an effective monopoly.
Of course, KV has responded to the criticism by pointing out that it will make allowances to ensure that no-one misses out on the drug due to financial hardship, but this till adds a layer of paperwork and stress to what was once a simple and cheap procedure. Also, i wonder if the drug company would give the same discount to Medicaid, or if the taxpayers will get kicked in the nuts by this as well.
[Mod mod]Changed “KB” to “KV” in title.[/Mod mod]
Well, no, but they have offered steep discounts to patients on Medicare and/or Social Security.
Thanks, mhendo.
I’m happy to climb on board. This is bullshit.
Nobody should be charged that amount for the drug. Not insurance companies, not the government, not self-payers, not nobody, not no how.
What law allows the FDA to give the exclusive right to manufacture an unpatented drug to any company?
The monopoly should be revoked and the company heavily fined for greed. Progesterone is widely available and very inexpensive. I’ve used it before and never paid more than a $5 co-pay. Any Republican legislators who allow this sort of free market blackmailing bullshit to continue have some serious explaining to do to the American public.
Uh, it’s not unpatented anymore. It’s not like this company won the patent lottery, they submitted the application and were granted.
More than likely, due to the continued off-label prescribing of the drug this specific company just went through the hoops to submit the new drug application. They demonstrated efficacy in this additional area, which extends a patent for the med to be prescribed for that use. This happens quite frequently with medications that are about to go off-patent in fact. They magically find another indication for the drug, or they slightly reformulate it in some way and push the newly branded med. I don’t see any reason why compounding pharmacies would not be able to continue producing the compounded version though.
I’m sorry, what’s this bullshit? Since when is this a Republican problem? You may have somehow managed to avoid noticing it, but we’re generally against the government handing out monopolies. It’s the Right, not the Left, which had been criticizing the FDA for years. You want to complain, go ahead. But don’t stick your head up your ass doing it.
Fucking Lefties always find some way to hyprocritically blame the Right for everything. :rolleyes:
According to some news sources, KV sent cease and desist letters to the compounding pharmacies to stop them from producing it. They’re covering all the bases…
Same here. I thought it was an outrage even before I realized women require multiple doses.
Can’t wait for all those pro-family politicians to weigh in (Santorum? Bueller?).
Glad someone posted this (not sure why I didn’t but needed doing so good on the OP).
This company seems dicey (the following is recent):
The FDA may have supplied them with the means to be greedy bloodsuckers, but the FDA did not make them greedy bloodsuckers.
For the record, I made an additional tyop in my original OP. The drug is named Makena, not Makema as in Marian and Pata Pata. It’s time for bed I guess.
Ah the irony… 
Great, just great. This drug is decades old and has been used to prevent premature births for quite a long time. Doctors have been ordering it from compounding pharmacies because the pharmaceutical companies weren’t making it. In other words, neither the drug nor this use of it is new. As I understand patent law, the most basic requirement for something to be patentable is that it be new. Does that rule somehow not apply to drugs?
Also, aren’t patents granted by the patent office? When did the FDA get the authority to grant patents?
I have no understanding of how the law works here.
What I have gathered is the government and medical community both felt having a manufacturer produce the drug provided some level of consistency and reliability and presumably a stable supply (i.e. rather than having to make a special order hospitals would just have some in stock). Presumably compounding pharmacies had less ability at quality control (which I can buy as a rationale although I have seen no one noting where things went wrong because a compounding pharmacy fucked up on this drug).
Doctors felt, originally, this would be a good move.
Everyone, near as I can tell, was stunned at the price increase. Doctors included. If anything you think prices would go down as a manufacturer would gain efficiencies that a compounding pharmacy could not achieve and still make a profit.
This is price gouging run amok.
What little I have gathered about this company (and posted a bit about above) makes me think the REAL tragedy here is how the FDA ever granted this to them. I want to know how that process works and who along the line made the decision to allow this and why.