FDA, KV Pharma Bend A Bit To Public Pressure; Lower Makena Costs, Allow Competing Drugs To Remain... For Now

from the public-pressure-works dept

Fri, Apr 1st 2011 1:55pm — Mike Masnick

We've been discussing how the FDA has been systematically banning drugs that have been on the market for years, and retroactively granting monopolies to particular pharmaceutical firms. The case that's drawn the most attention is that of Makena, a drug to prevent early childbirth which is provided on the market by a bunch of different firms, and was competitively priced around $10/dose. Yet, after the FDA stepped in and gave a monopoly to KV Pharmaceutical under the economically-clueless belief that this would help make the drug "more available," there was a massive public backlash when people discovered KV would increase the price of the drug from $10 to $1,500.

In response, it appears the FDA is backing down ever so slightly. Drew points us to the news that it has put out a statement that it will not stop other pharmacies from making and offering the drug. KV had been threatening others, but the FDA stepped in and said that, even though it's granted this monopoly to KV, it wouldn't enforce it against these other manufacturers. The FDA put up a statement explaining this:

In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products.

Of course, it also says it may change its mind on this at any time (i.e., after the attention and backlash die down) and appears to have no interest in revisiting its other new monopolies.

Not surprisingly, with this news in place, KV Pharmaceutical has also announced that it is dropping the $1,500 price down to $690. Of course, that's still a lot more than $10 per dose, and this seems in response to the fact that (a) the public is blasting it at every turn and (b) the FDA won't really enforce the monopoly... for now.

How about we try to fix the underlying problem of monopolies, rather than just focusing on this one case?

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Filed Under: drugs, fda, makena, monopolies, pharma
Companies: kv pharmaceutical

29 Comments

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:Lobo Santo (profile), 1 Apr 2011 @ 2:00pm

This sort of April Fools joke...
This sort of April Fools joke is mean.
Almost starts to get your hopes up until one realizes what day it is.

:-(
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Capitalist Lion Tamer (profile), 1 Apr 2011 @ 2:20pm

What a deal.
Temporarily marked down to 69 times its nearest (former) competitor's price.

Quick! Go get some while it's still at kidney-hocking prices!
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Mike42 (profile), 1 Apr 2011 @ 2:25pm

This is sick
"KV has defended Makena�s price, saying the company had spent more than $200 million to develop the drug"

Develop? Does this mean marketing, or kickbacks to the FDA?

"Because the drug must be given for about 20 weeks, Makena would cost about $30,000 for each at-risk pregnancy, which could add more than $4 billion to the nation�s health-care bill."

Oh, goody. We aren't spending enough on health-care as it is.

"KV�s stock price fell more than 20 percent Wednesday."

Lovely to know that so many investors would be looking to benefit from overpricing drugs used to help babies. They didn't dump the stock until after they fould out the FDA wouldn't go after other producers. Nice.
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Squirrel Brains (profile), 1 Apr 2011 @ 2:44pm

Re: This is sick
I was under the impression that KV did not actually develop this drug. I heard something about it being developed by Squibb but lost because of their misconduct.

The $200 million could have been the cost of setting up the required facility to mass produce the drug. That does sound steep, but hey, my knowledge of drug manufacturing is very limited.

I hope that the stock dropped because people finally realized what douches the managed were.
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Anonymous Coward, 1 Apr 2011 @ 4:53pm

@FDA:
Nice short-term solution. Now please come up with a long-term one.
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Mr Big Content, 1 Apr 2011 @ 6:13pm

Re: This is sick
I was under the impression that KV did not actually develop this drug.

They did not develop the generic version. But they did develop their own branded version. Don�t you think they should be entitled to a fair return on their precious Intellectual Property investment, and protection against those who would rip off their hard work?
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Anonymous Coward, 1 Apr 2011 @ 6:59pm

Two steps forward, one step back. Two steps forward, one step back.
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Anonymous Coward, 1 Apr 2011 @ 7:11pm

Then there is the story over on the Consumerist, where a gout drug has had its price jacked up out of the reach of someone who will die without it. It treats his heart disease, which the only other treatment is to have his chest cracked and the sack around his heart cleaned out.

Do the rich people understand if they manage to kill the rest of us off, they will have to mow their own lawns?
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Anonymous Coward, 1 Apr 2011 @ 7:36pm

Re:
This insanity will make the public hate IP more, and when the number of IP haters reaches a tipping point, we will likely see IP (both copy'right' and patents) substantially reduced, if not eliminated altogether.

The best thing IP maximists can do to maintain their laws is to make those laws more reasonable.
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Anonymous Coward, 1 Apr 2011 @ 7:41pm

Re: Re:
(and, personally, I can't wait till the day that these laws are gone. GO AWAY IP, AND DON'T COME BACK!!!).
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Any Mouse (profile), 2 Apr 2011 @ 1:43am

Re:
Wait, what? Please name the drug. Gout is a crystalization of uric acid in the joints, and while painful it is not deadly.
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JackPott (profile), 2 Apr 2011 @ 2:42am

ummm, non-lethal aside... i hope you're not claiming that (gout) pain is acceptable?!
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Anonymous Coward, 2 Apr 2011 @ 4:25am

Re: Re:
Correct me if I'm wrong but what I understood is that the guy is using a drug developed for Gout to treat his heart condition and that could be fatal for him without it.

Is that not what he said there?
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Anonymous Coward, 2 Apr 2011 @ 4:30am

Re: Re:
In other words a drug developed to treat something else is used to treat a heart condition.

That is what I understood anyways.
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JR Smith (profile), 2 Apr 2011 @ 5:32am

Re: Re: This is sick
In a word, no. This nothing more than a gigantic rip-off. Many of us are quite weary of the feds support of these immensely greedy corporations. It's way past time to reign them in. They're out of control and it's costing us all a fortune just so a few can get more damn money than anyone needs.
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JR Smith (profile), 2 Apr 2011 @ 5:35am

Re:
No, because they simply don't care about anything or anyone except their insane love of money. None of them would survive if they had to actually work.
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Gordon (profile), 2 Apr 2011 @ 7:27am

Re: Re: This is sick
Sooo....they made a copy then re-named it.

Tell me again how that is is developing a new thing? In fact if they didn't develop the drug in the first place then how could they possible be allowed a patent for their "Intellectual Property when in fact someone else created it?

Disclaimer: I'm not sure who actually came up with the drug but the wording in your comment suggests that another company originally created the drug.
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Anonymous Coward, 2 Apr 2011 @ 2:12pm

But, but, we lowered the original price by 95%!!!!1!11!! See what good guys we are? /sarc
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Anonymous Coward, 2 Apr 2011 @ 7:38pm

Re: Re:
Colchicine

http://consumerist.com/2011/04/colchicine-a-drug-primarily-used.html

"Hello, I have a major complaint about the doctor-prescribed medicine Colchicine. I am a 22 year old male in generally good health, however I was diagnosed three years ago with a medical condition known as Pericarditis, which is an inflammation of the sack around my heart. When this condition flares up I am tremendous pain and usually have to be admitted to the hospital. The only thing that helps me is the prescription drug Colchicine which I have to take twice a day, every day, for potentially the rest of my life as there is no cure for my type of Pericarditis outside of having my rib-cage cracked open and getting a bunch of junk scraped out. "
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Anonymous Coward, 2 Apr 2011 @ 11:19pm

Re: Re:
I tried posting the drug name and a link to the story on Consumerist, but I think the spam filter ate it.

The person in question has pericardia (sp) disease, and the gout medication keeps the inflammation down and him out of the hospital.

A drug manufacturer did some tests to get a 3yr exclusive on a drug that has been around for years. They jacked the price up and even with his insurance it is getting to where he can not afford it.
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tm, 3 Apr 2011 @ 2:59am

crony capitalism
Which of Obama's greedy friends are invested in KV?
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Anonymous Coward, 3 Apr 2011 @ 10:21am

Re: This is sick
Interesting fact how many of the babies born in this country are victims of mothers that spend much more than 20$ of their money on crack, cocaine and heroin to only cost the tax paying people of this country much more than. Tens of billions of dollars providing care paid for. By the government "we the people". So look at the big picture as most of the insurance companies already have . Of just pack and move to a socialist country and leave this one be for the free will open minded hard working tax paying people that built this land you call home .
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Jose_X, 3 Apr 2011 @ 12:16pm

Re: Re: This is sick
>> But they did develop their own branded version. Don�t you think they should be entitled to a fair return on their precious Intellectual Property investment, and protection against those who would rip off their hard work?

By fair return you were thinking monopoly gouging. Have a very wealthy group sitting on too much money with not enough return for their greed get monopoly control to exact on society the absolute highest price possible.
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Anonymous Coward, 3 Apr 2011 @ 9:36pm

Re: crony capitalism
While it is a nice try to blame the entire failed system on the current figurehead, this has taken years of grooming by lobbyists.

The biggest problem is in the signal to noise ratio of the interwebs, "HE"S A KEYAN!" "GREEDO SHORT FIRST!" etc. stories like this get very little coverage.

Our congress critters make multiple times more than the people they are supposed to "represent". Instead the align themselves with people who fill their campaign coffers and give them "special" treats.

The American people become to focused on the hot button issues that are spoon-fed to them to worry about.

As an example the "tea-party" faithful with their signs screaming no socialism while they collect their disability or medicare checks.
The bible-belt faithful screaming about the murder of the unborn, while making sure no money can be spent to educate kids to avoid the problem. Abstinence only works on paper, but instead they refuse to fund stopping the problem, they fear funding the murder of children, and they try very hard to avoid supporting all of these children who end up in the system.
The liberals who scream about the violation of the public's rights, but meanwhile rubberstamp the TSA policies that do nothing but move us closer to a police state.

There is plenty of blame to go around, but until the people stop voting for the "guy" with the best slogan and demand accountability we will get more of the same.

Corporations exist to make money.
Government is supposed to make the rules to make sure they do not make money at the expense of people.
The problem is we give lip service to demand better but we refuse to vote out the source of the problem because then we might not get control over the "important" issues.
Only when you discover that your local Evil Corporation has poisoned your drinking water, and they are going to do nothing to clean it up.
Then it does not seem to matter that much that someone who doesn't share your faith might consider an abortion to save her life across the country.

We have a "representative government" if this is how they represent us we must be insane.
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Anonymous Coward, 4 Apr 2011 @ 1:22am

Re:
More like: "two steps backward, one step forward"
rinse, lather, repeat?
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anymouse (profile), 4 Apr 2011 @ 7:35am

Re: Re: This is sick
So your answer to this is to have the GOVERNMENT (the ones 'subsidizing' the health care of these alleged 'crack, cocaine, and heroine' mothered babies) foot the bill to the tune of $30,000 per birth, rather than the generic cost of $300 per birth....

That will teach those dirty 'mothers' a lesson now, won't it? (and I'm not talking about the ones having the babies here).

1. Mandate health-care for all (subsidized by the government of course)
2. Grant monopolies to drug manufacturers so they can inflate prices 1000%
3. Kill babies.... by restricting use due to excessive cost to only government subsidized births
4. Profit... for the drug companies, and the senators and congress men they bought

Sounds like a plan, I'm sure I have a patent on this business model somewhere, or I can submarine one in there pretty quickly.... lets get some lawyers and get to suing, it's the American way after all right?

When did as American as Mom, Apple Pie, and Baseball become...

As American as Monopolies, Malfeasance and Litigation?
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Any Mouse (profile), 4 Apr 2011 @ 12:04pm

Re: Re: Re:
Thanks! I couldn't find that, and it's an interesting sidebar to the discussion. To the previous respondent, it was an honest question since I have gout and a high incidence of heart disease runs in my family, so knowing this sort of thing ahead of time is generally a /good/ thing.
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Anonymous Coward, 4 Apr 2011 @ 4:14pm

Re: Re: Re: Re:
The truly sad thing is the drugs been around forever and used to treat gout, the pharma did tests to prove it helped with gout and this got them the 3yr exclusive.

Mind you this is what I gathered, I might be misinformed but it sounds about right given how KV got their deal.
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Bob Calta, 3 May 2011 @ 7:17pm

Colchicine
Writing on this blog won't change anything. Email the White House and FDA to have your voices heard
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