FDA Tells Ther-Rx That Other Pharmacies Can Make Cheap Versions Of Makena

[filkertom]

Score one for the good guys:

Amid a national uproar by pregnant women and their doctors, the federal Food and Drug Administration today told a St. Louis company that it would allow special pharmacies to make a cheaper version of a newly approved drug to prevent premature births, in competition with the company’s higher-price medicine.

Ther-Rx Corp. received FDA approval Feb. 3 to market the drug Makena. It is similar to drugs doctors ordered from pharmacies making a customized version of the progesterone preparation at $9.80 a dose, or $200 for a typical course of 20 injections.

Ther-Rx bumped up the price of Makena to $1,500 a dose or $30,000 for a typical pregnancy, citing sterile work conditions and other costly regulations required to win and maintain federal approval.

This is a perfect example of why we need a strong government regulatory system, and why The Glorious Free Market is a crock of shit. These fuckers cared nothing for patients, nothing for anything but profit. Thankfully, the FDA slapped them down.

May they continue to have a spine in the future. 'Cause this isn't the last time we'll see something like this.

Comments

[niqaeli]

I don't know if you read In The Pipeline, but dude regularly has a pretty interesting perspective on Big Pharma, small pharma, and on the government regulatory agencies. His take on this: KV Pharmaceuticals and Makena: The FDA's Move.

[sethb]

The free market provides the $9.80 doses from compounding pharmacies. It's government regulation that almost prevented it.

[the-s-guy.livejournal.com]

So... is the new thing the same as the old thing, in which case it shouldn't have been able to be patented (or affect the old thing being sold), or is it a different thing, in which case it still shouldn't have been able to affect the old thing being sold...?

I'm just having a bit of trouble with the concept that a product put together recently in a laboratory and priced at $1500 a dose would be able to have any effect whatsoever on the availability of a drug that's been around for ages for $10 a dose. How does that work?

Wait... did Ther-Rx own the older drug as well and decide to stop making it?

[caraig.livejournal.com]

Hydroxyprogesterone caproate is also the same drug as a much older one called Delalutin, which was approved by the FDA in 1956 and was used to treat female hormone disturbances and cancer, but withdrawn from the market for business reasons in 2008, the agency says.

"Makena is chemically the same as Delalutin," [FDA Spokesperson Shelley] Burgess said.

So it's basically an older drug repackaged and repurposed.

[caraig.livejournal.com]

Oh, and I got the article from here: http://www.businessweek.com/lifestyle/content/healthday/649631.html

Basicaly Ther-Rx was citing that their special procedures for mixing Delalutin was what bumped the cost up by 150 times the original.

[caraig.livejournal.com]

There is an interesting press release about this here: http://www.sacbee.com/2011/03/30/3515260/ther-rx-corporation-commits-to.html It's basically by Ther-rx PR people and says that the company will be taking steps to make it affordable and available.

What I find interesting, however, is their disclaimer/CYA/"Don't blame us if we can't pull this off"/"We don't promise nothin'!" statement which looks to be about three times as long as the press release itself, which I'm sure they would have loved to have put in Planck font.

In other words, this is exactly why there needs to be government oversight and regulation of this sort of thing: So, at the very least, there's a third party who can look at this sort of thing and say 'Yes, they're telling the truth, this is an extremely complicated and sensitive process and it requires this sort of cost associated with it.' Or, 'No, they're full of crap.'

Now that this sort of price-gouging is striking close to where the Religious Right feels it most -- in the uterus -- I wonder if there will be more replies from Congress?

Oh, as an aside, now that the FDA made their announcement, KV Pharmaceutical's stock dropped 20%.

[bayushisan.livejournal.com]

You know I wasn't previously as pro-regulation as I am now. Having seen how much medical costs are I hope that the FDA gets more involved in the regulation of medicine and getting cheaper meds out there for the people who need them.

[chaotic-nipple.livejournal.com]

The obvious libertarian counter-argument is that by giving this company exclusive license to market a drug whose patent had expired, government intervention caused this particular problem in the first place. Randroids are wrong about a lot of things, but you can't blame them for this one.

[jenrose]

Y'know, hiring pricey call girls to mix it with their sterile toes is just not enough justification for a price hike, y'know?

Or maybe they were using special twee robot fairies that are very hard to build, to flutter their wings at it?

No, I know! They were mixing it in NASA-grade parabolic mirror dishes, and could only get one batch per dish before the dish warped out of true from the mixing process!

[jenrose]

That means, "Anyone who can't get their insurance to cough up the full contracted price is welcome to beg us for a handout. At which point we'll have their name and address and be able to sell it to telemarketers over and over again, as potential suckers."

[jenrose]

Aaaand if the government had just a little bit more regulation, they'd have limits on what they were able to charge. Next!

[admnaismith.livejournal.com]

I love you.

[starcat-jewel.livejournal.com]

Oh yes I can. Who petitioned for that exclusive license in the first place? Nobody just gave it to them. The Libertoonies utterly fail to acknowledge the corporate hand up the government's butt -- because of course corporations can do no wrong. It's as much bullshit as anything else they say.

[zibblsnrt.livejournal.com]

Precisely how did the government force them to raise the drug's prices 150-fold?

[nancylebov.livejournal.com]

It didn't, it just supplied the chance at a monopoly. Are you guys hoping to invent an ungameable system?

If that company had been more moderate (say, just raising the price 10-fold) do you think people would have cared enough to take action?

[filkertom.livejournal.com]

I have the feeling they would have been. A friend of mine who's an OB-GYN said all the doctors at her hospital were bent out of shape on this one because it's a fairly common and easy scrip for low-income women. Many of them can wrangle $200; $2,000, not so much. However, going from $200 to $30,000 was guaranteed to get everyone's attention, showcasing the incredible greed of Big Pharma.

[alverant.livejournal.com]

But it's the gubment's fault the hand was up there in the first place. You can't blame a business for wanting to make money using any method, no matter how morally objectionable, and seizing an opportunity when they see it.

[filkertom.livejournal.com]

Uh, yes, indeed, we can blame a business for etc. There are two agencies for such, one more readily enforceable than the other: regulations, i.e., laws, and reputation, i.e., public shaming. Sadly, the court of public opinion is more easily and commonly ignored these days, as long as the coffers are full.

[alverant.livejournal.com]

(You know I was being ironic in giving the libertoony answer right?)

You're right about public opinion. It doesn't mean anything and even if it did affect the bottom line, the ones in charge would just fire some low level employees to counter what was lost. It's not like they'll accept responsibility for their actions.

[shrewreader.livejournal.com]

Barriers to market entry: Not ever a good idea.

Now if we can just get the cable regulators to start seeing it that way.

[alverant.livejournal.com]

So who's going to be responsible for the infrastructure? Will everyone get to string cables on telephone poles? How about water? How many systems of pipes can you put under a city?

[stevemb.livejournal.com]

This just shows that corporatist rhetoric about "limited government" is just BS for the rubes. Corporatists want Big Government (as long as it's in a shape that fits neatly into their back pockets).

[shrewreader.livejournal.com]

Awww, details. If we wanted a functional governmental institution, we'd pay for it.

Although, you ask an interesting question -- how did they do it when they broke up AT&T?

[alverant.livejournal.com]

As I understand it they broke it up into regions. New Company A got one state and New Company B got another. Ta-da, no redundant infrastructure, just using existing ones. Worked out pretty well too.

[filkertom.livejournal.com]

Actually, ace, I didn't. It certainly sounds exactly like the argument they'd use. We've really gotta get HTML 5 to recognize an official < snark > or < sarcasm > tag....

[filkertom.livejournal.com]

Big, small... they want controllable government. Government responsive to the needs of business, no matter what it does to people, the environment, or (for that matter) the business environment. Short-term profit uber alles has become the mantra, and the notion of doing things more carefully, fairly, or less destructively has gone away.

[alverant.livejournal.com]

And how long have I been here? lol
Nice to know I can do a successful Poe. Next time I'll include the snark indicator.

Anyway, that's where I got the arguement from. They put all the blame for corruption on the one accepting the bribe, not the one giving it. I'm reminded of credit card companies who keep sending you applications and tempting people to buy buy buy then act surprised when the nation gets a lot of credit card debt. They just shrug their shoulders and deny any responsibility.

I don't shift blame entirely from government though. The SOB who approved of the monolopy should be fired for betraying the public trust and forfit whatever gifts he got for doing so. It's part of the difference between government and business. Government is there to support everyone and business is there just to support itself.

[lone-cat.livejournal.com]

No. Googling "Delalutin" shows that Bristol-Myers Squibb had it.

[johnridley.livejournal.com]

In case you haven't already seen Colbert's take on AT&T and breakup/mergers:
http://www.youtube.com/watch?v=rsCp-1hgfxI

[filkertom.livejournal.com]

I know, I know. It's just, every once in awhile I find out one of my friends believes something I didn't know s/he believed. Is all. And, even more than during the BushCo years, it's astonishingly difficult to tell snark and satire from What They Actually Said.

[bayushisan.livejournal.com]

My mom did the math on the increase in the drug and it turns out that Ther-Rx rasied the price upwards of 153,000%.

I understand that drug companies have to make enough money to stay in business but an increase of 153,000% seems more than a little excessive.

[alverant.livejournal.com]

Cute, but it's worth pointing out that AT&T didn't do the T-1000 until after the anti-trust regulations were relaxed.

I think it's time to take a sledge hammer to them again. (The company not the executives. But you know.... no no bad Al. No advocating violence even if it's richly deserved.)