I would expect the efficiencies to lower the cost of manufacture. With neither competition nor price regulation, what reason does the manufacturer have to pass those cost savings on to the consumer? Don’t any of the people who pushed for this idea know anything about market economics?
pohjonen is correct that KV is threatening to sue compounding pharmacies for making this drug. That’s what a patent is - the exclusive right to manufacture something. If KV didn’t have this right they wouldn’t be able to charge thirty times what the compounding pharmacies were charging (to be more exact, they wouldn’t make any sales at thirty times the market price).
BTW, is there any other field where a patent can be granted for a new use of an old invention? If I get a patent on a new type of wood saw, would I then be able to patent it as a metal saw when the original patent is about to expire? What is the difference between this and allowing a drug company to get a new patent for an off-label use of an existing drug for which their original patent is about to expire?
One would assume a manufacturer could produce the product for less.
If they continued to sell it for $20 or even $30 I doubt anyone would fuss about it. The company could make a tidy, if not huge, profit off it. I’m fine with that.
But $20 to $1500???
That is insane (albeit if you have an instant monopoly makes sense I guess since people have no other option). It is price gouging run amok.
This is an application of the Orphan Drug Act. I personally think this is an abuse of the law, mostly because KV Pharma took on basically no risk and bought it from someone who bought it from someone who bought it who relied on government studies. They’re paying more to buy the ANDA rights than they will to continue the studies currently in progress. More info here, with additional links.
Additionally, I wonder if the patient population really is small enough for the Orphan Drug Act to really apply.
It was the FDA that gave the company this monoploy. The FDA is not Republican. In fact, it’s part of the Executive Branch, an operational division of the Department of Health and Human Services. The FDA is headed by the Commissioner for Foods and Drugs, who reports to the HHS Secretary.
The HHS Secretary reports to the President.
The President is Barack Obama, a Democrat.
The HHS Secretary is Kathleen Sibelius, a Democrat appointed by Barack Obama and confirmed by a majority Democratic Senate run by Majority Leader Harry Reid, a Democrat.
The Commissioner for Foods and Drugs is Dr. Margaret Hamburg, a Democrat, appointed by Barack Obama and confirmed by a majority Democratic Senate run by Majority Leader Harry Reid, a Democrat.
March of Dimes has a working relationship with this company which is coming perilously close to ending over this price. I believe the company put in a lot of their own money to get the field trials and the approval; which doesn’t make it right, but which is their justification.
I think it’s seven years? Anyway there is some number of years after which the company can longer be the exclusive producer.
Did we ever expect that companies in a for profit business would charge what was “fair”?
Because this is exactly the sort of behavior Republicans have no problem with when it comes to our health care system. The private sector routinely jacks up prices for medical services and medications all the time. The Republicans have made it clear they don’t care just as long as we don’t have “socialized medicine.” President Bush’s basic response on this issue was to just go to an emergency room.
Frankly the Dems have hardly been any better. I am bitterly disappointed with Obama right now. I may not even vote for the SOB again because I don’t think he gives a damn about the ordinary middle class American. But denying access to medication if someone can’t afford it (and I sincerely doubt that someone without medical insurance will be able to afford multiple shots at $1500 per) is a Republican principle, not a Democratic one.
Republicans simply don’t give a shit if you die because you can’t afford medical treatment. They don’t or they would have fixed the fucking system that lets that happen years ago. They don’t care if bad things happen to you just as long as they adhere to their notions of principle. Malcolm Gladwell outlines the Republican philosophy quite nicely here.
The FDA shamefully gave out this monopoly. But it took private sector greed (a source of praise in Republican land) to dream up the disgusting price increase. Republicans would ultimately simply not care if a woman gave birth to a premature baby solely because she could not afford this treatment.
Normally I cite the cost of years and years of research to explain some of the cost of meds (full disclosure: I work for a hospital doing medical research on human volunteers, which includes studies from the government, pharma companies, and private agencies), and definitely the cost of the numerous drugs that have failed to be safe/produce results after many years of development and testing. However, that does not appear to be the case here. Hell, I’ve filed applications with the FDA for a whole lot less compensation. Fuck this company for having such gall.
The fact remains that this decision was implemented at every level by Democrats, with nary a Republican voice in sight, and yet you blame the Republicans because… because… because it’s “exactly the sort of behavior Republicans have no problem with.”
Seriously? The Democrats do it, but your blame goes first to the people that have no problem with it?
How about FIRST blaming the people that, you know, actually DID it? Then if you must you can shoot an offhanded barb at the people that you claim don’t have a problem with it.
In case you haven’t noticed the person leading the charge against this company is a Democrat. The FDA gave this company a monopoly to help make sure the product was safe and effective. Supervision of the private market is a principle of the Democratic party.
I sincerely doubt that the Dems (or anyone at the FDA) expected company officials to act like greedy assholes. Two Democratic senators are trying to get this company’s behavior to change and get the FDA’s decision revoked.
But were they unable to get company officials to back down most Reps would hardly give a damn if women without health insurance were unable to get access to this drug because they couldn’t afford it.
Well in most patent litigation, the means test is usually first use, most use. I’m not sure what patent protection exists in the Orphan Drug Act, but I would expect patent lawsuits to follow this move unless the Act grants them necessary protection from lawsuits.
Yes, and how convenient of you to ignore the litany of complaints against the FDA from Republicans, especially since an artificial monopoly award to a company that did NOT invest any particular effort in design and research is a false signal to the free market and an action that Republicans decry.
And good for them… but if the DEMOCRATS in charge of HHS, FDA, and the White House would act, then no one would need to “try” and get the FDA’s decision revoked, would they?
And what could Republicans do to reverse this, if they wanted to? Nothing. This is entirely in the hands of Democrats.
This is beyond ridiculous. The decision was made by Democrats, and Demorats would be the ones to revoke it. Take off your partisan blinders and put the blame where it belongs.
I hope you won’t be too offended by my off-handedly noting the your fingers aren’t broken. And I KNOW that you’re capable of crafting a perfectly serviceable rant. Could I request that YOU step up and tear the Obama administration a new one for being (at the very least) asleep at the switch wrt this issue (even if only to show us how it’s done, if it turns out that you don’t really have a problem with it)?
I agree with you that Republicans did not do this. Also, to the extent that it is connected with any particular party, i think the Democrats have to accept some responsibility because, as you note, Democrats are the people who currently run the Administration, and who are in the positions with direct oversight of the FDA.
But i don’ think it’s correct to say that “this decision was implemented at every level by Democrats.” It was implemented at every level by career FDA employees, who are not political appointees, and happened to occur under a Democratic Administration. And i would say the same about Republicans if they were in the White House right now. If some direct order or political intervention, or even a more general policy change, attributable to the Obama administration is found to be the cause of the problem, i will amend my position.
But no information that i have read so far suggests that the process of getting FDA approval for this drug, or the monopoly that goes along with it, was in any way outside normal FDA procedures or the result of specific changes made by the Democrats. What we have, in this particular instance, is a structural failure of policy. The very fact that this can happen without some sort of direct political intervention, and simply as a result of following standard bureaucratic FDA procedures is, in itself, extremely problematic in my opinion, and bespeaks lack of thought and concern among those who put the procedures in places. And i think that both parties bear some burden of blame for that situation.
Come on Bricker, you are right to say that its not directly the Republican’s fault, but to say that Obama himself or any of his political appointees is ludicrous. The drug was approved by a board of civil servants whose political affiliation are unrelated to their position. It is also silly to use Republican opposition to the FDA as a claim that they are on the right side. The Republicans hate the FDA becuase it is a regulatory agency and Republicans opposition to regulation in general, not because the FDA grants patents. In general since long term patents and intellectual property rights make money for big business, the Republicans seem to be in favor of them.
Until one side or the other comes out in favor of KV, its not really a Republican or Democratic issue. Its more an issue of a greedy company, and a gullible review board who didn’t think that the company would be so greedy.
The Republicans are currently attacking the FDA right now to reduce the food safety budget and the number of food safety inspectors so I am not exactly impressed with their claims against the FDA.
Disgusting, huh?
Republicans control the House of Reps right now. Do you really think they couldn’t do anything in this case?
The truth is that you see two Republican principles at work here: an unfettered free market and the constant mantra that fetuses are sacred. When the free market threatens the fetus I am left with amusement as I wonder which one the Reps will pick.
Dems granted this monopoly to help make sure the drug was safe. Do you really think they thought the company in question would respond in such an outrageous fashion?
I agree it is problematic (and agree with the rest of your post) but I disagree that this necessarily bespeaks a lack of thought and concern (it might but I need to know more).
Considering that this has not happened before (that I am aware of) I’d say a company found a cheesy way to exploit the rules for their own benefit. Frankly, people/companies look for ways to game the system all the time (e.g. Enron).
It is a hole that, now exposed, needs to be corrected to be sure. The whole policy seems crazy to me (who the hell grants a freaking monopoly?).
