The FDA: Doing their part to raise the cost of health care...

[Bill Mattocks]

http://abcnews.go.com/Health/Womens...ture-births-skyrockets-drug/story?id=13104588

Preventing preterm births just got 150 times more expensive, now that KV Pharmaceuticals has gained exclusive rights to produce a progesterone shot used to prevent premature births in high-risk mothers.
Although the shot has been available in unregulated form from specialty compounding pharmacies for years for $10 a pop, the Food and Drug Administration recently granted KV Pharmaceuticals sole rights to produce the drug, which will be marketed as Makena and cost $1,500 per dose -- an estimated $30,000 in total per pregnancy.

From $10 per shot to $1500 per shot. Your tax dollars at work. Yeah, that's right, you paid for the work that went into this:

"All the upfront development of the drug was done by the National Institute of Health. You and I paid for that with our tax dollars, it's not like this pharmaceutical company is trying to recoup its investments in research and development, as is usually the reason for the price of new drugs," says Dr. Kevin Ault, associate professor of gynecology and obstetrics at Emory University School of Medicine.

Doctors were hoodwinked into supporting the FDA's move:

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."

No comment from the FDA. Can't imagine why. Whose pocket are they in this time?

 

[cdunn]

Not the first time stuff like this has happened - These kind of things happen because someone has to pay for trials and scale-up, and their 'reward' is the exclusive contract.

It happened to colchicine last year, which people have been using as a treatment for gout for 7000 years, but for which there was no formal dosing schedule and the known potential for lethal diarrhea as a side effect. We've got the schedule now, and the price went up about 250-fold as a result of exclusive marketing rights.

 

[LuckyKBoxer]

Not the first time stuff like this has happened - These kind of things happen because someone has to pay for trials and scale-up, and their 'reward' is the exclusive contract.

It happened to colchicine last year, which people have been using as a treatment for gout for 7000 years, but for which there was no formal dosing schedule and the known potential for lethal diarrhea as a side effect. We've got the schedule now, and the price went up about 250-fold as a result of exclusive marketing rights.

Death by Diarrhea has to be on the 100 worst ways to die list..

 

[bushidomartialarts]

One of the most common in the world, too.

 

[K-man]

Not the first time stuff like this has happened - These kind of things happen because someone has to pay for trials and scale-up, and their 'reward' is the exclusive contract.

It happened to colchicine last year, which people have been using as a treatment for gout for 7000 years, but for which there was no formal dosing schedule and the known potential for lethal diarrhea as a side effect. We've got the schedule now, and the price went up about 250-fold as a result of exclusive marketing rights.

I find this amazing. I've been retired a while but years ago when I first graduated, the dose for treating acute gout was 1mg to start then 500mcg every hour until symptoms were relieved or nausea or diarrhoea occurred. In more recent times the dose was humanely reduced to 500mcg three times a day. I never actually heard of anyone getting into trouble with the earlier dosing schedule and the price was dead cheap. The dose has been known for many years, the signs of toxicity likewise. To allow a company exclusivity for conducting research to verify known information is unbelievable. Bureaucracy at its very best. :erg:

Can't wait until they do the trials on Vitamin C!

 

[granfire]

I find this amazing. I've been retired a while but years ago when I first graduated, the dose for treating acute gout was 1mg to start then 500mcg every hour until symptoms were relieved or nausea or diarrhoea occurred. In more recent times the dose was humanely reduced to 500mcg three times a day. I never actually heard of anyone getting into trouble with the earlier dosing schedule and the price was dead cheap. The dose has been known for many years, the signs of toxicity likewise. To allow a company exclusivity for conducting research to verify known information is unbelievable. Bureaucracy at its very best. :erg:

Can't wait until they do the trials on Vitamin C!

Oh good grief, that would mean oranges by prescription only?!

 

[K-man]

Oh good grief, that would mean oranges by prescription only?!

That's right, and only $10 each!

If you don't like that, then you'll just have to suck on a lemon.