Price of drug to prevent preemies jumps from $20 to $1,500 PER DOSE after FDA approval

[Liberal_in_LA]

Price of drug to prevent preemies jumps from $20 to $1,500 after FDA approval

The price of a drug used to delay birth in women at high risk of delivering prematurely is going to skyrocket following Food and Drug Administration approval of a prescription form of the product, a synthetic form of the hormone progesterone.

Since 2003, the American Congress of Obstetricians and Gynecologists has recommended that doctors offer the progesterone shots to high-risk women. But because there has not been a commercial product available, women have obtained the drug from so-called compounding pharmacies, which make it to order. The pharmacies have typically charged about $10 to $20 per shot for the drug, which is given weekly.

Last month, however, the FDA approved a commercial form of the drug, called Makena, manufactured by K-V Pharmaceutical Co. of St. Louis. The company said Wednesday that the drug will be available for shipping March 14 and that it will cost $1,500 per dose. The company said, however, that it would establish a "comprehensive patient assistance program" to ensure that the drug was available to every woman who needs it.

http://www.latimes.com/health/boostershots/la-heb-premature-drug-03092011,0,4847507.story

[villager]

1. Thank God for healthcare "reform!"

n/t

[tosh]

5. Yep, and that backrroom deal with Pharma.

:eyes:

[MannyGoldstein]

2. But we should still be able to get it from the compounding pharmacies

As long as docs and patients care.

[Horse with no Name]

3. Not sure here

BUT I don't think so. IT will be patented and there won't be a generic form available.

[MannyGoldstein]

6. Once it's generic, it can't be made un-generic

I'm pretty sure.

[Horse with no Name]

8. It wasn't generic. It was a compound.

And it is bullshit--I agree.

[joshcryer]

4. I was going to ask that. If it's still available from the old method, spread the word.

[Horse with no Name]

7. In the article

>>>snip
Meanwhile, women are unlikely to be able to continue to get the drug at compounding pharmacies. K-V sent letters to the pharmacies warning them of potential FDA action if they keep distributing the drug.

[Liberal_in_LA]

9. So K-V will be the only company allowed to manufacturer a drug that was already available. amazing

[Horse with no Name]

10. Sickening, isn't it? Predatory capitalism. n/t

[joshcryer]

12. It looks like they're two different drugs, actually.

New drug: http://en.wikipedia.org/wiki/17-Hydroxyprogesterone_caproate and here http://en.wikipedia.org/wiki/17-Hydroxyprogesterone

Wikipedia is slightly out of date there, I'd update the article but I'm lazy today.

Old drug (a hormone more like): http://en.wikipedia.org/wiki/Progesterone

Honestly it feels to me, from reading this, that the FDA dropped the ball. Progesterone, a well established drug in use for well over a decade, being supplanted by a drug that is new and not as well tested and indeed with preliminary studies that suggest it's not as good.

Advocates need to fight this if progesterone cannot be acquired via legal or other means (if only it means pushing the FDA to allow it to be considered for this particular purpose).

[MannyGoldstein]

16. Sadly, FDA doesn't decide "better"

Only (relative) safety and efficacy. A new drug could be far less effective than an older drug with a great safety record, but the FDA has to approve the new drug as long as it works at least a little bit and is not (in their opinion) dangerous.

[Drahthaardogs]

11. This is criminal

Just awful

[alphafemale]

13. Of course..."prolifer" lawmakers are now seeking to criminalize women who don't get it at any cost..

///sarcasm////

[golddigger]

14. How's that deal with Big Pharma working out for you Obama?

[MannyGoldstein]

17. It's working out just fine for him.

He's having a nice relaxing night, being served wonderful food by attentive servants.

Are you?

[kohodog]

15. Simple Answer

"Only reprobates have premies. It's your own fault --signed, GOD, with props to all the Libertarians and Republicans who have prayed so hard for this."

[spanone]

18. ain't that america

[bonytaosborn]

19. sadness

this makes me sad. why is it that everything needed to live a
healthy life in america becomes super expensive and nearly
inaccessible? and why do people seem to always vote against
things that would help them and make their lives so much
better? i don not understand why the working people of america
continualy vote themselves into hardship.