Progesterone shot, once $10, is now $1,500 after FDA grants monopoly
The drug’s importance, [Dr. M. Kathryn Menard] says, cannot be understated. “This is the only evidenced based approach we have, medication we have to prevent pre-term birth.”
Menard said, like others in the field, she had supported efforts to win FDA approval for the drug, believing it “would make it easier for our patients to get the drug.” Now, she says, she is outraged. “This financial barrier, we see it as insurmountable.”
Unbelievable. I’m torn between feelings of outrage and the desire to start purifying my own blood for beer retirement money. (Incidental point: How, exactly, is it legal to copyright a hormone? Especially when KV Pharmaceuticals didn’t fund any of the clinical trials? Inquiring minds.)
I hope this is the straw that breaks whatever political backs are necessary to prevent this from happening again.
Action Potential 
This is not dissimilar to the recent FDA “approval” of colchicine, rebranded as Colcrys. I mean, seriously, Ben Franklin was using colchicine and NOW all of the sudden it needs to be FDA approved. So now, old guys with gout are paying something like $5/tablet (without insurance) for something that used to cost them 5¢. And hey, alcohol is cheaper, so if they had to pick…well, I would have a hard time counseling them to stay compliant if those were their two options.
Awesome. And I didn’t know about the FDA approving colchicine… jeez, you’re right. From 5 cents to $5 a tab, I’d have a hard time staying compliant, too.
Wow, that is ridiculous- thankfully it is probably still cheaper for insurance companies to pay for the shots than to pay for all the time a preemie spends in the NICU… so maybe they’ll pay. I can’t believe the FDA approved this though.
Yeah, it’s so disappointing. I really feel like there’s a lot more to this story, but I don’t know if there’s a hidden but logical reason for this company to have gotten the patent, or just back room bribes. I hope more comes about about it in the press.
The problem is that these babies will still probably have to spend time in the NICU.
And another problem – FREAKIN’ MARCH FOR DIMES SUPPORTS THIS BS.
Here’s a great reference to a blog about it from a preemie mom who happens to be a physician on the side. 🙂
http://www.preemieprimer.com/march-of-dimes-response-to-makena-pricing-reveals-they-are-woefully-out-of-touch/
1) Gaaaah, why, March of Dimes – WHY?
2) That’s a really awesome post,, thanks!
3) … okay, I just checked the blog’s about page, and in addition to being a preemie mom AND a physician, she’s quadruple-board-certified. How awesome is that?
Well there are still suppositories or does the patent outlaw their use?
I used the suppositories (luteal phase defect) because those progesterone shots are hell and they leave lots of lumpy subq scar tissue.The studies say a suppository is just as effective, maybe this will change the delivery method.
M